Fernandez et al.

British Journal of Anaesthesia 102 (2): 21620 (2009)

doi:10.1093/bja/aen369

Compa rative study of topical anaesthesia with lidocaine 2% vs levobupivacaine 0.75% in cataract surgery
S. A. Fern a ndez 1*, E. Dios2 and J. C. Diz3 4
Department of Anaesthesiology and Resuscitation and Department of Ophthalmology, Pontevedra 3 Provincial Hospital Complex, Pontevedra, Spain. Department of Functional Biology and Health Sciences, 4 University of Vigo, Spain. Department of Anaesthesiology, Complejo Hospitalario Universitario de Vigo, Spain
*Corresponding author. E-mail: soledad.abel.fernandez.lopez@sergas.es
Background. This study compa red the efficacy of topical a naesthesia with levobupiv acaine 0 .75 %vs lidocain e2% during cataract surgery by phacoem ulsifiction. a Methods. A prospecti e, random ize , double v d -blind study comparing two agen ts for topical a nae sthesia in cataract surgery. Two hundred and forty-six consecuti patients ve undergoing corneal phacoemulsific tion were enrolled into two groups to recei e either topical a v levobupiva- caine0.75%(n126) or lidocaine2% (n120). The m ain outcom e variablesof the study were intraoperative and postoperative pain, requirement for additonal anaesthesia, i patient comfort and cooperation, surgeonsatisfaction, and corneal epithelial toxicity induced by topical drugs. Results. Levobupivacaine 0.75%provided significantly better analg esiath an lidocaine2% during cataract surgery (P,0.001) at the end of surgery (P,0.002), and up to 30 min after surgery (P,0.001). There were no statistically signific differences between the two groups ant 5 h after surge Epithelial toxicity was sim ilar in both groups, and patient comfort and ry. surgeonassessment of patient cooperation were better in the levobupiv acaine group. Conclusions. Topical anae sthesiawith levobupivacaine 0.75%was more effective than lidocaine 2 % in preventing pain and improving patient and surgeoncomfort during cataract surge with ry, similar toxicity. B r J A na e 20 09; 102: 21620 sth Keywo rds: anae sthetic techniqu topical; levobupiv es, acaine;lidocain surge cataract e; ry, Acceptedfor publication: December 2, 2008
1

Cataract is a major cause of blindness worldwide, and the only effective treatment is surgery. Topical anaesthesia has become the anaesthetic technique of choice for this type 2 of surgery in the USA. Although topical anaesthesia was described by Koller in 3 1884, Fichman was the first to use topical anaesthesia in 4 cat- aract surgery in 1992. Since then, lidocaine has been the most widely used anaesthetic in this type of surgical technique.5 Lidocaine belongs to the amine amide chemical class of local anaesthetics, which determines its liposolubility properties and anaesthetic potency. Its basic mechanism of action is to inhibit membrane depolarization and thus block nerve conduction. Despite being a very safe drug, lidocaine has potential neurotoxic, cardiotoxic, and 6 cytoxic effects. Levobupivacaine,7 the levorotatory isomer of the

racemic mixture of bupivacaine, has advantages over lidocaine: lower arrhythmogenic potential, lesser inotropic effect on cardiac muscle, and less depressing action on the 8 central nervous system.

The aim of this study was to determine which of the two study anaesthetics (lidocaine 2% vs levobupivacaine 0.75%) was more effective and safe for topical use in cataract surgery by phacoemulsification.

Methods
A prospective, randomized, double-blind study was conducted in 246 patients undergoing elective cataract surgery

by phacoemulsification under topical anaesthesia and sedation at the Pontevedra Hospital Complex (CHOP). The study was approved by the Clinical Research Ethics Committee of Galicia. All patients signed informed consent to participate in the study. Patients were divided into two groups and received a topical instillation of one drop every 2 min for 6 min before surgery and one drop before intraocular lens insertion either of lidocaine 2% (L group, 120 patients) or levobupivacaine 0.75% (LB group, 126 patients). Patients were

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Age (yr) 74.7 (33 - 91) 75.3 (44 - 89) Sex 0.56

0.51 F 76 (63.3) 74 (58.7)

Lidocaine vs levobupivacaine in cataract surgery

ASA

excluded if they were younger than 65 yr, had any psychiatric illness (including significant anxiety), nystagmus, insufficient pupil dilatation, allergy to local anaesthetics, inability to understand language, or if the patient refused 9 the topical anaesthesia technique. All surgical procedures were performed by the same surgeon (E.D.) and anaesthesiologist (S.A.F.) using the same surgical and anaesthetic technique in all patients.

Table 1 Pain assessment 0 1 2 3 4 5 No pain or discomfort Occasional burning or stinging sensation I Sensation of0gravel or sand in the eye, burning, or pressure (0) Sensations in point 2 intensified 2 (1.7) Continuous discomfort 0.61 Mild painII 81 (67.2) 83 (66.1)

(5) very comfortable, does not interfere with the surgical III technique. 39 (32.8) Pain (the main study variable) was scored during phacoemulsification and at the end of the surgery, and at 30 min and 5 h after surgery using the modified Stevens test (Table 1). In addition, any increase of 20% or greater for baseline heart rate and arterial pressure values was con14 sidered an abnormality caused by pain or anxiety. Other variables assessed were the need for supplementary use of intracameral anaesthetic and corneal epithelial alterations observed by slit-lamp examination on the day after surgery, which was classified as: the absence of corneal epithelial alterations, mild alteration, or the presence of signifi15 16 cant alterations in the form of an epithelial punctate. Finally, the degree of patient satisfaction was scored by interview by the surgeon as poor, good, or excellent. The data obtained were analysed using the SPSS 11.0 program. Descriptive statistics including the mean, standard deviation, and ranges were calculated for quantitative variables. Qualitative variables were expressed as percentages. Comparisons between qualitative variables were 2 performed using the x test or Fishers exact test. Quantitative variables were compared with paired data Students t-test after checking the normality of the distributions by the Kolmogorov Smirnov test. A value of P,0.05 was considered significant.
41 (32.2)

Anaesthetic technique
Baseline vital signs were taken in all patients on arrival at the day-case surgery room, followed by placement of an i.v. line with normal saline solution and application of the pupil dilatation protocol previously established by the surgeon (topical application of tropicamide 1%, cyclopentolate 1%, and phenylephrine 10%). Patients received i.m. sedation with clorazepate dipotassium 25 mg rv20 min before entering the 10 operating theatre, where after starting monitoring, the study anaes- thetics were administered in a random, double-blind fashion. A nurse prepared the assigned medication accord- ing to the predetermined randomization table in syringes labelled with the study and patient codes, whose content was unknown to the 11 anaesthesiologist or surgeon. Haemodynamic variables were recorded on arrival at the operating theatre, at the start of the procedure, at the time of phacoemulsification, on completion of the procedure in the operating theatre, and on patient discharge from the day surgery room.

Surgical technique
Surgery was performed after prior conjunctival and periocular cleansing with povidone iodine 5% and 10% sol12 ution, respectively. In all patients, a 2.8 mm clear corneal incision was made at the most curved axis. Phacoemulsification was performed by the divide and w conquer technique using the Legacy unit (Alcon, USA) with implantation of an acrylic intraocular lens into the capsular bag through a sutureless incision. The study variables recorded were discomfort on instil- lation of the anaesthetic (the presence or absence of burning or stinging, scored by anaesthesiologist), degree of patient cooperation (scored from 1, poor cooperation, to 5, excellent cooperation, 13 scored by surgeon); and surgeon comfort scored on the following scale: (1) severe discomfort, surgeon is unable to continue the surgical technique; (2) moderate discomfort, the surgical technique is performed with great difficulty; (3) mild discomfort, restricts the surgical technique at some moments during the procedure; (4) comfortable, interferes with the surgical technique at some moments because of movement of the eyeball;

Results
Baseline characteristics of the sample are shown in Table 2. The results for the study variables are shown in Table 3. No differences were found in burning sensation on instillation of the anaesthetic (78.3% in the L group vs 73% in the LB group, P0.37). This burning sensation was mild in all cases and less than that caused by instillation of the cycloplegic agent.
Table 2 Baseline characteristics of the sample. Values are shown as number 2 (%) or mean (range) for age. P-values derived from x tests or Fishers exact test for sex, or Students t-test for age Lidocaine (n5120) Levobupiva caine (n5126) P-value

Ferna?ndez et al.
Table 3 Study outcome variables. Values are shown as number (%) or mean 2 (SD) for surgical duration. P-values derived from x tests or Fishers exact test or Students t-test for surgical duration Lidocaine (n5120) Levobupiv acaine (n5126) Burning with anaesthetic 94 (78.3) Burning with antiseptic 36 (30) Haemodynamic 14 (11.7) disturbances Surgical duration 18.1 (6.9) Patient satisfaction Poor 0 (0.0) Good 40 (33.3) Excellent 78 (65) Patient cooperation 1 0 (0) 2 7 (5.8) 3 20 (16.7) 4 44 (36.7) 5 49 (40.8) Surgeon comfort 1 2 (1.7) 2 5 (4.2) 3 19 (15.8) 4 42 (35) 5 52 (43.3) Epithelial alterations None 86 (71.7) Mild 27 (22.5) Significant 7 (5.8) 92 (73) 31 (24.6) 6 (4.8) 17.2 (6.5) 1 (0.8) 40 (31.7) 85 (56.5) 1 0 14 43 68 (0.8) (0.0) (11.1) (34.1) (54) P-value

Table 4 Intraoperative and postoperative pain (according to the modified 2 Stevens scale). Values are shown as number (%). P-values derived from x test Lidocaine (n5120) Levobupiv acaine (n5126) P-value

0.37 0.39 0.06 0.30 0.37

0.017

0 (0) 1 (0.8) 10 (7.9) 41 (32.5) 74 (58.7) 101 (80.2) 22 (17.5) 3 (2.4)

0.025

0.21

There were no differences in haemodynamic alterations or surgical duration between the two groups. Patient satisfaction was similar. Patient cooperation during the prosurgeon comfort was also better (P0.025). No differences in corneal epithelial alterations were observed on the day after operation. Only three patients from the LB group and seven from the L group showed significant alterations in the form of an epithelial punctate (Table 3). The main study variable, pain, was significantly higher during the procedure (Table 4 and Fig. 1) in the L group, in which 21.6% of patients reported continuous discomfort or mild pain, compared with 4% of patients in the LB group (P,0.001). No patients were given supplementary local anaesthesia during surgery. There were significant differences in the values obtained for pain at the end and 30 min after operation: no pain or discomfort was reported by 81.7% and 95.3% of patients in the LB group, respectively, compared with 58.3% and 79.2% in the L group (P0.002 and 0.001). No statisti- cally significant differences were found in the pain assess- ment at 5 h after operation (P0.80). No severe adverse reaction related to the study drugs was observed.

Intraoperative pain 0 1 2 3 4 5 Pain at end of surgery 0 1 2 3 4 5 Pain at 30 min 0 1 2 3 4 5 Pain at 5 h 0 1 2 3 4 5

16 33 33 12 22 4 48 22 41 4 4 1 72 23 23 0 2 0

(13.3) (27.5) (27.5) (10.0) (18.3) (3.3) (40.0) (18.3) (34.2) (3.3) (3.3) (0.8) (60.0) (19.2) (19.2) (0) (1.7) (0)

42 (33.3) 46 (36.5) 21 (16.7) 12 (9.5) 5 (4.0) 0 (0) 77 (61.1) 26 (20.6) 18 (14.3) 4 (3.2) 1 (0.8) 0 (0) 98 (77.8) 22 (17.5) 6 (4.8) 0 (0) 0 (0) 0 (0) 46 (36.5) 38 (30.2) 28 (22.2) 10 (7.9) 2 (1.6) 0 (0)

,0.001

0.002

0.001

43 (35.8) 41 (34.2) 25 (20.8) 7 (5.8) 1 (0.8) 0 (0)

0.80

procedure and rapid

Discussion
The current trend in anaesthetic techniques for cataract surgery is towards increasingly less aggressive methods that allow safe performance of the surgical

4 3 2 1 0 Surgery End

Lidocaine vs levobupivacaine in cataract surgery (SD) according to modified Stevens scale. Using Students t-test: P,0.001 Lidocaine for the comparison of Groups LB and L at surgery, end, and at 30 min, Levobupivacaine and P0.77 for the comparison of Groups LB and L at 5 h.
3

30 min

5h

Fig 1 Intraoperative and postoperative pain. The bars indicate mean pain

recovery of the patient. More than 61% of cataract surgeries in the USA are now done under topical anaesthesia, largely as a result of the great advances in 2 surgical techniques. There are few randomized safety and efficacy clinical trials on which is the best anaesthetic technique or local anaesthetic for cataract surgery or even on which pharma17 18 ceutical form should be applied (gel and eye drops). It is known that the ideal anaesthetic should have low systemic toxicity and not be harmful or cause permanent

Pain mean (SD)

Ferna?ndez et al.

changes to tissues; it should be effective in topical use with a rapid onset of action and a sufficient duration of the anaesthetic effect to perform the procedure with short recovery period. Since the use of cocaine, a potent topical anaesthetic with vasoconstrictive properties, but with severe side19 effects that cause irreversible scarring of the corneal epithelium, to the present, the use of other drugs such as 20 tetracaine has been proposed, but its short duration of action makes its use unrecommendable and today it is only used in brief ocular examinations (tonometry). Other drugs such as ropivacaine never achieved good results as a 21 topical anaesthetic for cataract surgery. Lidocaine (in concentrations ranging from 2% to 5%) remains the most widely used local anaesthetic today because of its intermediate potency, intermediate latency, short duration (1 2 h), weak systemic toxicity, and high therapeutic index, but it shows cytotoxicity 22 directly related to its concentration. On the other hand, levobupivacaine, a recent local anaesthetic, meets sufficient conditions for safety because it is the levorotatory isomer 23 24 of bupivacaine. Although the efficacy of lidocaine has been well 25 documented to date, this is one of the first studies on the use of levobu- pivacaine as a topical anaesthetic in cataract surgery. The results obtained allow us to state that although both anaesthetics are effective for this type of surgical technique, pain reported by patients during the surgery was less in the levobupivacaine group. In the lidocaine group, a greater proportion of patients had discomfort or mild pain, although no patient required additional analgesia. The results for pain at the end of surgery remained favourable to levobupivacaine, which maintained this advantage in the pain assessment at 30 min after operation. This difference decreased over time and pain scores were similar in both groups at 5 h after surgery (Fig. 1). With regard to the other study variables, the greater surgeon comfort and better patient cooperation in the LB group was notable. Both were probably influenced by the main study variable, pain, since the better the analgesia, the better the patient cooperation and surgeon comfort. It is also notable that there were no differences between the two groups in postoperative corneal epithelial punctate, indicating a similar iatrogenic effect of both drugs. On the basis of the results of our study, we can conclude that levobupivacaine 0.75% was more effective in preventing pain during cataract surgery. Furthermore, surgeon comfort and patient cooperation were better in the group treated with levobupivacaine 0.75%. No difference was observed in corneal epithelial toxicity between the groups.

Hospital Complex.

Funding
The cost of this work was exclusively supported by the Department of Anaesthesiology of Pontevedra Provincial

Lidocaine vs levobupivacaine in cataract surgery

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