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The American Journal of Surgery 215 (2018) 570e576

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The American Journal of Surgery


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Pain control with continuous infusion preperitoneal wound catheters


versus continuous epidural analgesia in colon and rectal surgery: A
randomized controlled trial
Nicolas J. Mouawad a, *, Stefan W. Leichtle a, Christodoulos Kaoutzanis a, Kathleen Welch b,
Suzanne Winter b, Richard Lampman a, Matt McCord a, Kimberly A. Hoskins a,
Robert K. Cleary a
a
Department of Surgery, Saint Joseph Mercy Health System, Ann Arbor, MI, United States
b
Center for Statistical Consultation and Research, The University of Michigan, Ann Arbor, MI, United States

a r t i c l e i n f o a b s t r a c t

Article history: Objective: To compare continuous infusion preperitoneal wound catheters (CPA) versus continuous
Received 3 February 2017 epidural analgesia (CEA) after elective colorectal surgery.
Received in revised form Methods: An open-label equivalence trial randomizing patients to CPA or CEA. Primary outcomes were
28 May 2017
postoperative pain as determined by numeric pain scores and supplemental narcotic analgesia re-
Accepted 13 June 2017
quirements. Secondary outcomes included incidence of complications and patient health status
measured with the SF-36 Health Survey (Acute Form).
Keywords:
Results: 98 patients were randomized [CPA (N ¼ 50, 51.0%); CEA (N ¼ 48, 49.0%)]. 90 patients were
Analgesia
Epidural
included [ CPA 46 (51.1%); CEA 44 (48.9%)]. Pain scores were significantly higher in the CPA group in the
Colorectal PACU (p ¼ 0.04) and on the day of surgery (p < 0.01) as well as supplemental narcotic requirements on
Wound catheter POD 0 (p ¼ 0.02). No significant differences were noted in postoperative complications between groups,
Pain aggregate SF-36 scores and SF-36 subscale scores.
Surgery Conclusions: Continuous epidural analgesia provided superior pain control following colorectal surgery
in the PACU and on the day of surgery. The secondary endpoints of return of bowel function, length of
stay, and adjusted SF-36 were not affected by choice of peri-operative pain control.
© 2017 Elsevier Inc. All rights reserved.

1. Introduction surgical wound via continuous infusion catheters. Blockade of pa-


rietal nociceptive afferents by continuous infusion of local analge-
Perioperative analgesia is a vital part in the management of sics through these wound catheters has been used in cardiac,6
surgical patients, affecting well-being and hospital length of stay thoracic,7 biliary,8 and spinal9 surgery. Continuous preperitoneal
(LOS). Neuraxial anesthetics infused through epidural or spinal analgesia (CPA) is a promising pain management alternative, per-
catheters have become routine pain management options for pa- formed by the surgeon placing an infusion catheter directly into the
tients undergoing colon and rectal surgery. These techniques, preperitoneal plane prior to closing the wound at the end of sur-
however, are labor-intensive, expensive,1,2 and results vary with the gery. CPA has the potential to decrease systemic narcotic re-
type of operation.3,4 In colon and rectal surgery, continuous quirements and narcotic-related side effects in the immediate post-
epidural analgesia (CEA) using local anesthetics has been shown to operative period.
be significantly more effective than systemic intravenous patient- To date, there has been limited experience with CPA in
controlled analgesia within the first 2 postoperative days.5 Alter- abdominal surgery and conflicting results10 ranging from no ben-
natively, local analgesics may be administered directly to the efits11 to a significant reduction in postoperative narcotic use and
LOS have been reported.12 In the latter study, CPA was also found to
reduce the incidence of surgical site infections.
* Corresponding author. St Joseph Mercy Health System, 5333 McAuley Dr, The purpose of this study was to compare the efficacy of CPA
Reichert Health Building R-2111, Ann Arbor, MI 48106, United States. versus CEA in patients undergoing elective colorectal surgery, as
E-mail address: nmouawad@gmail.com (N.J. Mouawad).

http://dx.doi.org/10.1016/j.amjsurg.2017.06.031
0002-9610/© 2017 Elsevier Inc. All rights reserved.

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Fig. 1. CONSORT Flow Diagram.

measured by the Numeric Pain Scale (NPS), the need for supple- 2.2. Participants
mental narcotic analgesics, and quality of life using Short Form 36
(SF-36) Health Survey Questionnaire subscale scores. We hypoth- Patients eligible for enrollment were male or female, 18 years of
esized that postoperative pain control via CPA was equivalent to age or older, who presented for elective colon and rectal surgery at
CEA. our institution, and were able to give informed consent and com-
plete a patient questionnaire. Exclusion criteria were any docu-
mented allergic reactions to morphine, hydromorphone, lidocaine,
2. Methods bupivacaine and/or fentanyl; anatomic contra-indications to
placement of an epidural catheter such as spinal stenosis or spinal
2.1. Trial design fusion; emergent surgery; systemic infections; unwillingness to
participate in follow-up assessments; and vulnerable populations.
This prospective randomized controlled single-center clinical No recruitment incentives were employed.
trial was conducted over a 21-month period at St Joseph Mercy
Hospital Ann Arbor (SJMH). It was a parallel assignment interven- 2.3. Randomization
tional model with open label masking, managed per the principles
outlined in the Declaration of Helsinki and approved by the Insti- Randomization was performed using a computer-generated
tutional Review Board at SJMH (HSR 09-1061). The trial has been random numbers table with permutated blocks of ten. The pa-
registered on clinicatrials.gov (NCT01552226). All patients pro- tients were randomized using a 1:1 ratio after providing written
vided written informed consent, obtained by a trained research informed consent in the outpatient clinic. Following randomiza-
coordinator before enrollment (Fig. 1). tion, health care providers, research staff, and patients were not

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blinded to study treatment arm. forced-air warming upper body blanket system.

2.4. Outcome measures 2.8. Preperitoneal catheter placement technique

The primary aim of the study was to compare post-operative Prior to fascial closure, two small stab incisions were made
pain control, as measured by a visual analog NPS number ranging about 4e5 cm left and right of the cephalad midline incision. The
from 0 (no pain at all) to 10 (worst pain ever) between the CPA introducer and peel-away sheath were placed into the preper-
group and the CEA group. This was evaluated immediately after itoneal space under direct vision at a 30e45 angle in a “roof-top”
surgery in the post-anesthesia care unit (PACU), on the day of configuration, from cephalad to caudad, via these incisions. After
surgery and on post-operative days (POD) 1 through 4. In the PACU priming the catheters with saline, the catheters were passed
patients were asked about their current pain. For POD 1 through 4, through the sheath thereby positioning them in the preperitoneal
patients were asked to record their average, current, and maximum space on the left and right side. The size of the catheter used (5 in,
NPS score for the previous 24 h. 10 in, 15 in) was based on the length of the incision. For minimally
The secondary outcome measures were: (1) Amount of sup- invasive procedures (laparoscopic and robotic), if there was a port
plemental narcotic analgesia required by the study groups in incision available in the upper quadrants, this was used instead of a
morphine equivalents; (2) Time to return of bowel function; (3) separate stab incision. The catheter was connected to the *ON-Q
Incidence of complications; (4) LOS; (5) Quality of life (QoL) as Painbuster Pump (*ON-Q® PainBuster® Post-Op Pain Relief System,
measured with the SF-36 Health Survey Questionnaire (Acute I-Flow Corporation), which was filled with 540 mL of 0.5% bupi-
Form)®. vacaine that delivered 4e5 ml per hour. The peritoneum, fascia, and
The SF-36 is a well-recognized, extensively validated, self- skin were closed in the standard fashion.
administered tool that assesses health status on physical, social, Post-operatively, both study groups were managed in a similar
and emotional levels.13e15 It contains questions about a patient's fashion, receiving back-up Patient Controlled Analgesia with
pain level and therefore, can be complementary to the NPS and intravenous hydromorphone until oral analgesics were sufficient,
patient narcotic requirement measurements. The SF-36 has an at which point the epidural and preperitoneal catheters were
overall aggregate scale and eight subscales. Each subscale ranges discontinued.
from 0 to 100, with a higher score indicating a more favorable
health state. This form was completed by consenting patients on 2.9. Statistical analysis
the day of surgery scheduling (survey 1), as well as at two and four
weeks post-operatively (surveys 2 and 3). Sample size calculations were based on the goal of demon-
strating equivalence between the CEA and CPA methods of deliv-
2.5. Study procedures ering post-operative analgesia, using the confidence interval
approach to establish equivalence.16
Patients randomly assigned to the CEA group or CPA group The sample size calculations for the NPS analysis were based on
received this intervention in the preoperative preparation suite or the trial of Carli et al.5 We assumed that average CPA pain scores
intraoperatively, respectively. would be considered equivalent to those of CEA if the mean CPA
pain score was no more than 1 mm higher than mean CEA pain
2.6. Epidural technique score on a 10 mm scale. Based on this assumption, 51 patients in
each group were required to determine if CPA is equivalent to CEA
Standard thoracic epidural (T6-T12) via a loss-of-resistance for providing pain control, with a power of 80% at a significance
technique using a BD Continuous Epidural Tray #406151 (Becton, level of 0.05. To allow for 10% participant drop-out, a recruitment
Dickenson and Company, Franklin Lakes, New Jersey) was goal of 57 patients per group was planned for this study.
employed in the CEA group after premedication with midazolam The hospital Data Monitoring Committee requested an interim
(0.02e0.04 mg/kg) and fentanyl (0.5e1 mcg/kg). After satisfactory analysis once patient accrual was greater than 50%. At the time of
placement, each catheter was tested with 3e5 ml of 1.5% Lidocaine interim analysis, 110 patients were assessed for eligibility. Twelve
with 1:200,000 epinephrine. Prior to completion of the surgical patients were excluded (did not meet inclusion criteria or they
procedure, all patients received an 8e10 ml bolus of 0.125% bupi- declined to participate). After randomization, 8 cancelled surgery (4
vacaine without epinephrine. In the PACU, an epidural infusion of in each group). Therefore, the data were analyzed with a total of 90
6e10 ml of 0.0625% bupivacaine was initiated using a Hospira patients (78.9% of anticipated accrual) on an intention to treat basis.
Gemstar pump (Hospira, Lake Forest, Illinois). Initial comparisons were carried out in terms of demographic
characteristics, co-morbidities, perioperative factors, and baseline
2.7. Anesthetic technique: intra-operative care SF-36 scores. Continuous variables with symmetric distributions
(e.g., age) were compared using independent samples t-tests. Cat-
All patients received general endotracheal anesthesia. Anes- egorical variables with a large number of cases (e.g., gender) were
thesia was induced with fentanyl (1.0e3.0 mg/kg), propofol compared using Pearson chi-square tests, while those with insuf-
(0.5e2.5 mg/kg), and succinylcholine (1e1.5 mg/kg) or rocuronium ficient cases for a Pearson chi-square test (e.g., tobacco use) were
(0.4e0.6 mg/kg) for muscle relaxation. All patients were main- compared using Fisher's exact test. Pre-operative co-morbidities
tained with a balanced technique using isoflurane, desflurane, or and intra-operative factors were compared for CPA vs. CEA using
sevoflurane, and muscle relaxant as needed. Unless otherwise Fisher's exact test.
contraindicated, all patients received 0.1e0.15 mg/kg of intrave- Post-operative NPS scores in the PACU were compared using an
nous dexamethasone near procedure initiation and 15e30 mg of independent samples t-test. Average NPS on POD 0 through 4 were
intravenous ketorolac near procedure termination. Thirty minutes compared using a repeated measures analysis of variance (ANOVA)
prior to case completion, local anesthetic (bupivacaine) was infused model, with an autoregressive correlation structure, to take into
into the epidural or wound catheter. Reversal of residual neuro- account correlation among observations on the same subject.
muscular relaxation was accomplished with neostigmine and Treatment group (CPA vs. CEA) was a between-subjects factor and
atropine if necessary. Body temperature was maintained with a POD (0 through 4) was a within-subjects factor; the interaction

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between these two factors was also included as a predictor in the between the CPA and CEA groups (all p-values  0.25). However,
model. Based on this model, the post-hoc differences between the the average preoperative SF-36 aggregate score was significantly
mean NPS for CPA and CEA were calculated for POD 0e4. Pain higher (better) (p ¼ 0.03) and physical functioning score was
scores were considered to be equivalent if the 90% confidence limit marginally higher for the CPA than the CEA group (p ¼ 0.06). All
for the difference was between 1.0 and 1.0.16 Results for the other SF-36 subscale scores did not differ significantly between the
comparisons between NPS for CPA and CEA were reported in terms two groups (all remaining subscale p-values  0.10).
of equivalence based on an assessment of the pre-specified confi-
dence limits for differences between the groups, and also using p- 3.1. Postoperative analgesia
values.
Supplemental narcotic usage (morphine equivalent dose) was Postoperative NPS scores were significantly higher (worse) in
examined for POD 0 through 4. Because this variable was highly the CPA group than in the CEA group in the PACU (p ¼ 0.04) and on
skewed, a natural log transformation was used to make the distri- the day of surgery (POD 0, p < 0.01), and were declared to be non-
bution more symmetrical (after adding 1 to allow values of zero to equivalent. Although there was not a significant difference in the
be included in the analysis). As had been done for post-operative NPS between the two groups on POD 1, the pain scores were
NPS, we used a repeated-measures ANOVA model with an autor- declared non-equivalent on this day because the upper 90% CI for
egressive correlation structure. Because NPS was analyzed on the the difference was greater than 1.0 (the pre-specified limit for
natural log scale, comparisons between the two treatment groups equivalence). The average NPS for the CPA group were declared
were expressed as the ratio of mean narcotic dose for the CPA group equivalent to those in the CEA group for POD 2, 3, and 4. The NPS in
vs. the CEA group. A ratio greater than 1.0 indicates a higher the PACU and on POD 0e4, along with the 90% CI for the difference
narcotic dose for the CPA group, while a ratio less than 1.0 indicates (CPA score minus CEA score), an assessment of the equivalence of
a higher dose for the CEA group. The 95% confidence intervals (CI) the pain scores, and the p-value for the comparison between the
for these ratios were calculated for each POD. Supplemental groups are shown in Table 2.
narcotic usage was not used for one patient in the CPA group due to Supplemental narcotic use was significantly higher in the CPA
incorrectly entered data. The supplemental narcotic usage for one group than in the CEA group on POD 0 (p ¼ 0.02), but not on POD 1
patient in the CEA group was only available up until the time of through 4 (Table 3).
intubation for a second surgery to correct a small bowel injury, and
was included up until this point. 3.2. Patient health status
The SF-36 quality of life aggregate scale and eight subscales
were calculated for Surveys 1 through 3 (survey 1 was administered Post-operative SF-36 data was available for 45 (97.8%) patients
pre-operatively, while survey 2 and 3 were administered at two in the CPA group, and for 42 (95.5%) patients in the CEA group.
weeks and four weeks post-operatively, respectively) for each pa- Thirty-six (80%) in the CPA group and thirty-five (83%) in the CEA
tient based on the scoring instructions from the Rand 36-Item group completed all three questionnaires. In the unadjusted anal-
Health Survey.14 A higher score on any subscale indicates a more ysis, there was a significantly higher (better) aggregate score for
favorable outcome. Pre-operative SF-36 scores (survey 1) were CPA than for CEA (p ¼ 0.03 and p ¼ 0.02, respectively) and for the
compared as part of the baseline comparisons of the two groups, physical functioning subscale at 2 weeks and at 4 weeks (p ¼ 0.02
using independent samples t-tests. Unadjusted post-operative SF- and p ¼ 0.01, respectively) as well as for the energy subscale at 4
36 scores (surveys 2 and 3) were compared using a repeated weeks (p ¼ 0.04). None of these differences remained significant
measures ANOVA model. The outcome was the subscale score and after adjusting for their corresponding baseline (preoperative)
the predictors were group (CPA vs. CEA), time (survey 2 or 3), and subscale scores (Table 4).
their interaction. An initial unadjusted comparison was made for
the postoperative SF-36 surveys per the research protocol, and a 3.3. Postoperative return to bowel activity and complications
later analysis, adjusted for preoperative SF-36 scores, was also
performed. The adjusted analysis could not be carried out for role The median time to return of bowel activity in the CEA group
limitation due to emotional problems due to insufficient was 22.5 h (CI ¼ 20.0e23.3 h) and in the CPA group was 23.3 h
participants. (CI ¼ 15.0e30.0 h), which was not statistically significant (p ¼ 0.53).
A Kaplan-Meier survival analysis was used for time (hours) until Complications occurred in 2 patients (4.4%) of the CPA group,
return of gastrointestinal function; groups were compared using a and in 4 patients (9.1%) of the CEA group (p ¼ 0.43). Complications
log-rank chi-square test. LOS was defined as day of discharge minus were independent of pain control method (CPA: ureteral injury;
day of operation, and compared between the CPA and CEA groups CEA: 2 intra-abdominal hemorrhage, deep venous thrombosis,
using an independent samples t-test. A composite score of “any small bowel injury).
complication” was constructed (score ¼ 1 for complication;
score ¼ 0 no complication); this score was compared for the two 3.4. Hospital length of stay
groups using Fisher's exact test due to the very small number of
patients with complications. A significance level of 0.05 was used The LOS did not differ significantly between patients in the CPA
for statistical tests. All analyses were carried out using SAS soft- group with a LOS (mean ± SD) of 4.5 ± 3.0 (range 1.0e14.0 days),
ware, release 9.3 (©SAS Institute, 2002e2010, Cary, NC). and patients in the CEA group with a LOS (mean ± SD) of 5.0 ± 4.0
(range 2.0e26.0 days), p ¼ 0.47.
3. Results
4. Discussion
Ninety-eight patients were randomized to receive either CPA
(N ¼ 50, 51.0%) or CEA (N ¼ 48, 49.0%). Ninety patients underwent In this comprehensive assessment of pain management and
the surgical procedure and received the allocated intervention (46 quality of life after elective colorectal surgery, CEA provided supe-
(51.1%) CPA and 44 (48.9%) CEA). Table 1 demonstrates that there rior pain control compared to CPA, particularly in the early post-
were no significant differences in demographic characteristics, co- operative period. The superiority of CEA in the PACU and on POD
morbidities, operative indications, and perioperative factors 0 was not seen from POD 1 through 4, although the confidence

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Table 1
Comparison of demographic characteristics, co-morbidities, and perioperative factors between the continuous preperitoneal analgesia (CPA) and the continuous epidural
anesthesia (CEA) group.

CPA (N ¼ 46) CEA (N ¼ 44) P-value

Male (N, %) 28 (60.9%) 23 (52.3%) 0.41a


Age years (mean ± SD) 59.4 ± 12.2 60.8 ± 12.6 0.49b
BMI kg/m2 (mean ± SD) 29.1 ± 6.6 29.6 ± 5.9 0.68b
Tobacco use (N, %) 8 (17.4%) 4 (9.1%) 0.25a
Narcotics use (N, %) 4 (8.7%) 2 (4.6%) 0.68c
Diabetes (N, %) 4 (8.7%) 3 (6.8%) >0.99c
Blood Thinners (N, %) 3 (6.5%) 3 (6.8%) >0.99c
Primary Diagnosis (N, %) 0.70c
Malignancy 21 (45.7%) 24 (54.6%)
Diverticulitis 19 (41.3%) 13 (29.6%)
IBD 2 (4.4%) 3 (6.8%)
Other 4 (8.7%) 4 (9.1%)
Surgical Approach (N, %) 0.85c
Open 8 (17.4%) 6 (13.6%)
Laparoscopic 3 (6.5%) 2 (4.6%)
Robotic 35 (76.1%) 36 (81.8%)
Procedure Type (N, %) 0.47c
Partial Colectomy 33 (71.7%) 35 (79.6%)
Lower Pelvic Anastomosis 13 (28.3%) 9 (20.4%)
Wound class II (clean contaminated; N, %) 45 (97.8%) 43 (97.7%) >0.99c
Preoperative SF-36d subscale
Aggregate score 74.7 ± 14.6 (N ¼ 44) 67.0 ± 17.9 (N ¼ 42) 0.03b*
Physical Functioning 83.3 ± 21.4 (N ¼ 44) 73.3 ± 26.0 (N ¼ 41) 0.06b
Role limitations PHe 65.6 ± 48.1 (N ¼ 8) 55.0 ± 49.7 (N ¼ 10) 0.65b
Role limitations EPf 75.0 ± 50.0 (N ¼ 4) 60.0 ± 54.8 (N ¼ 5) 0.68b
Energy 61.8 ± 17.0 (N ¼ 42) 55.3 ± 18.8 (N ¼ 41) 0.10b
Emotional 69.5 ± 13.2 (N ¼ 42) 64.6 ± 19.0 (N ¼ 41) 0.18b
Social 84.1 ± 23.9 (N ¼ 44) 75.0 ± 27.3 (N ¼ 42) 0.10b
Pain 76.4 ± 27.5 (N ¼ 43) 74.1 ± 23.4 (N ¼ 42) 0.68b
General Health 70.7 ± 19.1 (N ¼ 44) 65.4 ± 21.0 (N ¼ 42) 0.22b
*
Statistically significant.
a
P-value based on Pearson Chi-square test.
b
p-value based on independent samples t-test.
c
p-value based on Fisher's Exact test.
d
Higher SF-36 score indicates greater well-being.
e
PH: physical health.
f
EP: emotional problems.

intervals for the differences between the two groups indicated that subscale score at four weeks post-operatively, although these dif-
CPA was non-equivalent to CEA for numeric pain score (i.e., not ferences were no longer present in the adjusted analysis. The SF-36
within 1 unit on the 10-unit scale) on POD 0 and 1. Our study is pain subscale did not show any significant differences between the
unique in that the majority of patients had the robotic approach groups. These findings, which seem in contradiction to those for
and rectal resections were included. pain control and supplemental narcotic usage, may be explained by
It is noteworthy that the CPA group had more favorable QoL the fact that the pain scores and supplemental narcotic require-
scores based on the unadjusted SF-36 aggregate scale, physical ment comparisons were made in the acute recovery phase, while
functioning subscale, and energy subscale at two weeks post- the SF-36 surveys were made at two weeks and four weeks post-
operatively. It also had a significantly higher physical functioning operatively, after patients had more time to recover. Importantly,

Table 2
Comparison of Postoperative Numerical Pain Scores (NPS)g between the continuous preperitoneal analgesia (CPA) and the continuous epidural anesthesia (CEA) group in the
post-operative anesthesia unit (PACU) and on post-operative day (POD) 0 through 4.

Time Point CPA CEA Mean Difference (CI)b Equivalencec P-value


a a
N NPS Mean (SD) N NPS Mean (SD)

PACU 44 3.5 (2.8) 41 2.3 (2.5) 1.16 (0.21e2.10) Not equivalent 0.04d,f
POD 0 45 3.9 (2.0) 44 2.6 (1.7) 1.20 (0.56e1.84) Not equivalent <0.01e,f
POD 1 46 3.2 (1.8) 44 2.6 (1.9) 0.61 (0.03 to 1.25) Not equivalent 0.11e
POD 2 45 2.6 (1.7) 43 2.1 (1.7) 0.33 (0.39 to 0.98) Equivalent 0.39e
POD 3 37 2.9 (1.9) 39 2.7 (1.9) 0.08 (0.59 to 0.76) Equivalent 0.84e
POD 4 26 3.1 (2.1) 26 2.7 (1.8) 0.15 (0.63 to 0.94) Equivalent 0.75e
a
Number included in analysis differs by post-operative day.
b
CI: 90% confidence interval for the difference in mean NPS for CPA minus CEA.
c
Equivalence is demonstrated if the 90% confidence interval is between 1.0 and 1.0.
d
p-value based on an independent samples t-test.
e
p-value based on post-hoc comparisons from the repeated measures analysis of variance model.
f
Indicates a significant difference between groups, p < 0.05.
g
NPS ranges from 0 to 10, with higher score indicating greater level of pain.

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Table 3
Comparison of supplemental narcotic usagee between the continuous preperitoneal analgesia (CPA) and the continuous epidural anesthesia (CEA) groups.

POD CPA CEA Ratio of Meansc (95% CI)d P value

Na Geometric Mean Median (25th/75th)b Na Geometric Mean Median (25th/75th)b

0 45 20.5 (14.2e29.5) 25.6 (9.6/47.4) 44 11.0 (7.1e16.6) 13.8 (4.4/29.8) 1.80 (1.09e2.96) 0.02*
1 45 29.0 (20.1e41.8) 38.4 (14.7/60.8) 44 23.0 (14.4e36.4) 31.2 (11.4/55.2) 1.25 (0.73e2.16) 0.42
2 43 22.4 (14.2e35.1) 21.2 (9.6/64.8) 43 21.2 (13.9e32.0) 31.1 (10.4/48.0) 1.01 (0.58e1.77) 0.98
3 34 17.4 (10.4e28.6) 15.7 (8.8/32.6) 37 16.0 (10.7e23.7) 20.0 (10/30.2) 0.94 (0.54e1.65) 0.83
4 29 6.9 (3.7e12.3) 10.0 (5.0/15.4) 29 9.2 (5.1e15.9) 15.0 (5.0/27.0) 0.74 (0.38e1.43) 0.36
a
Number included in analysis differs by post-operative day.
b
25th percentile, 75th percentile.
c
Ratio of Mean narcotic usage for CPA to mean narcotic usage for CEA.
d
CI ¼ 95% confidence interval for the ratio of mean narcotic usage for CPA to mean narcotic usage for CEA.
e
Supplemental narcotic usage measured in mg/kg/day morphine equivalent.

there were no differences between the groups with regard to the peripheral vasoconstriction, and subsequent reduction in inflam-
incidence of complications. matory mediator release from neutrophils, decreased neutrophil
Satisfactory postoperative pain control is of utmost importance adhesion to exposed endothelium, and reduced formation of oxy-
for colorectal surgery patients. Thirty to 80% of patients experience gen free radicals.23,24 Local anesthetics may have antimicrobial
moderate to severe pain in the postoperative period, and often feel properties against a wide spectrum of human pathogens, making
that physician and non-physician providers do not sufficiently local infiltration and continuous wound infusion potentially ad-
emphasize the importance of pain relief.17e19 vantageous with respect to surgical site infections.25 The etiology is
Numerous studies have compared various methods of pain thought to be bacteriostatic/bactericidal acid-base changes of the
control, including CEA and CPA after various types of oper- local milieu by the local analgesic agent. Our study did not confirm
ations.20e22 In a randomized trial, Jouve et al. compared CEA and the results of these studies as there was no difference in surgical
CPA after open partial colectomies and found an outcome similar to site infections between CPA and CEA groups.
ours,20 although their study design included traditional open sur- This study has inherent limitations and potential for bias. It is a
gery and none had a minimally invasive approach. Their trial single-center single-surgeon study; blinding was not possible
stopped enrollment after only 50 patients, because of significantly because the routes of treatment administration after randomiza-
lower pain scores (ranging from 0 to 100) after 24 h in the CEA tion were obvious in both groups. Patient perceptions may vary and
group (10, range 1.6e20) than in the CPA group (37, range 30e49; we made no attempt to control for previous patient experiences
P < 0.001). In another randomized controlled trial including pa- and what information patients may have received from family and
tients undergoing open surgery only, Bertoglio et al. demonstrated friends. Many institutions administer fentanyl with the local
non-inferiority of CPA compared to CEA in the first 24 h post- anesthetic for epidural infusion and this option may have improved
operatively in 106 patients after open partial and total colectomy.21 pain scores for the CEA treatment arm had it been used in this
Moreover, CPA was found to be superior to CEA with regard to pain study. We decided not to administer fentanyl in the CEA arm so as
scores and supplemental narcotics after 48 h. to compare 2 primary perioperative pain management treatment
Supplemental opioids and unrelieved pain have been implicated methods without narcotics, and use narcotics only as back up pain
as risk factors for the development of surgical site infections due to options. Multimodal pain management regimens typically employ
inhibition of the local inflammatory response to injury through non-steroidal and other non-narcotic pain medication options. No

Table 4
Comparison of unadjusted and adjusted SF-36a aggregate score and eight subscale scores between the continuous preperitoneal analgesia (CPA) and the continuous epidural
anesthesia (CEA) groups.

SF-36 Subscale Unadjusted Comparison Adjusted Comparisonb

Two Weeks Post-Surgery Four Weeks Post-Surgery Two Weeks Post-Surgery Four Weeks Post-Surgery

CPA N ¼ 37 CEA N ¼ 36 P CPA N ¼ 43 CEA N ¼ 38 P CPA N ¼ 37 CEA N ¼ 36 P CPA N ¼ 43 CEA N ¼ 38 P


Mean (SE) Mean (SE) Mean (SE) Mean (SE) Mean (SE) Mean (SE) Mean (SE) Mean (SE)

Aggregate Score 62.3 (2.4) 53.8 (2.8) 0.03f 72.6 (2.2) 64.5 (2.7) 0.02f 60.6 (2.3) 55.9 (2.3) 0.15 71.3 (2.1) 66.4 (2.3) 0.13
Physical 55.6 (3.2) 43.8 (3.6) 0.02f 71.5 (2.7) 59.3 (4.2) 0.01f 53.8 (3.0) 47.0 (3.1) 0.12 69.5 (2.8) 62.2 (3.0) 0.09
Functioning
Role Limitation 56.9 (7.4) 52.1 (9.0) 0.68 85.4 (7.6) 67.6 (11.3) 0.23 52.0 (23.7) 48.9 (19.6) 0.92 92.9 (27.6) 80.3 (22.3) 0.74
PHc
e
Role Limitation 51.5 (14.5) 39.7 (12.5) 0.55 75.0 (17.1) 62.5 (15.7) 0.68 – e e e e e
EPd
Energy 49.3 (3.1) 59.7 (2.6) 0.08 59.7 (2.7) 52.2 (2.9) 0.04f 47.6 (2.8) 42.5 (2.7) 0.20 58.7 (2.7) 53.6 (2.7) 0.19
Emotional 71.2 (2.6) 65.9 (2.3) 0.16 70.1 (2.8) 67.5 (2.5) 0.43 69.7 (2.5) 67.6 (2.4) 0.54 68.3 (2.4) 69.5 (2.4) 0.72
Social 64.5 (4.7) 58.3 (5.2) 0.34 79.9 (3.6) 75.3 (4.2) 0.47 64.5 (4.4) 59.0 (4.5) 0.39 79.7 (4.2) 75.8 (4.4) 0.52
Pain 59.9 (4.7) 54.5 (4.4) 0.37 78.7 (3.0) 69.7 (4.0) 0.09 60.4 (4.1) 54.9 (3.9) 0.33 78.8 (3.9) 69.8 (3.8) 0.10
General Health 74.1 (3.2) 67.1 (3.3) 0.21 75.9 (2.9) 70.0 (3.2) 0.15 71.6 (2.4) 69.2 (2.5) 0.50 74.8 (2.3) 71.8 (2.4) 0.38
a
Higher SF-36 score indicates greater well-being.
b
Adjusted for corresponding preoperative SF-36 subscale score.
c
PH: physical health.
d
EP: emotional problems.
e
Insufficient cases for adjusted analysis.
f
Indicates a significant difference between groups, p < 0.05.

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576 N.J. Mouawad et al. / The American Journal of Surgery 215 (2018) 570e576

attempt was made to control for these other pain medication op- 918e923.
7. Wheatley 3rd GH, Rosenbaum DH, Paul MC, et al. Improved pain management
tions in this study. Furthermore, delivery of local anesthetic to the
outcomes with continuous infusion of a local anesthetic after thoracotomy.
preperitoneal space via a previous port site may leak the anesthetic J Thorac Cardiovasc Surg. 2005;130:464e468.
into the general peritoneal space such that the anesthetic would 8. Gupta A, Thorn SE, Axelsson K, et al. Postoperative pain relief using intermit-
not remain “local” and effective relieving pain at the abdominal tent injections of 0.5% ropivacaine through a catheter after laparoscopic cho-
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This study has led to the preference of CEA over CPA as the pain ropivacaine continuous wound instillation after spine fusion surgery. Anesth
management option of choice for elective colon and rectal surgery Analg. 2004;98:166e172.
10. Liu SS, Richman JM, Thirlby RC, Wu CL. Efficacy of continuous wound catheters
patients at our institution. The exceptions to this standard are pa- delivering local anesthetic for postoperative analgesia: a quantitative and
tients who are not candidates for epidural catheters due to qualitative systematic review of randomized controlled trials. JACS. 2006;203:
anatomic, systemic or patient factors. Other pain management 914e932.
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options currently under future investigation at our institution for electronic patient-controlled analgesia device and a double-catheter system
this patient population include transversus abdominis plane does not decrease postoperative pain or opioid requirements after major
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laparotomy. Br J Surg. 2001;88:357e359.
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