Randomised controlled trial on the effectiveness of lidocaine gel vs tetracaine drops as the sole topical anaesthetic agent for primary pterygium surgery

Abstract

Purpose To determine the effectiveness of lidocaine 2% gel vs tetracaine 1% drops in primary pterygium surgery. Methods This was a prospective, randomised controlled trial. Forty consecutive patients who had primary pterygium underwent surgical excision of primary pterygium and mitomycin C. Patients were randomised into two groups. Group 1 received tetracaine 1% drops and solcoseryl eye gel (Solco Basel AG, Switzerland). Group 2 received xylocaine 2% gel (lidocaine hydrochloride 2% gel, AstraZeneca, Sweden) topically and normal saline drops 0.9%. Additional tetracaine drops were given to patients who experienced pain preoperatively. The primary outcome was the pain experienced during and after surgery. Immediately after the operation, pain and discomfort scores were assessed by the patients and doctor using a 10-point linear analogue scale. The stages of the operation were divided into the following: stage 1Ffirst incision, stage 2Fpterygium body excision, stage 3Fconjunctival suturing, and stage 4Fimmediate postoperative after patching. Results There was no statistically significant difference in the mean pain scores experienced during pterygium excision (3.03 ± 2.35 for the lidocaine group and 3.98 ± 2.18 for the tetracaine group). However, for stage 3, there was a statistically significant difference in mean pain scores experienced during closure (P ¼ 0.03) (0.47±0.84 for the lidocaine gel group and 1.43±1.66 for the tetracaine group), with patients of group 2 experienced less pain. The mean number of additional drops required by the eyes in lidocaine gel group was also significantly (0.16±0.11) less than the tetracaine group (0.67 ± 0.09, P ¼ 0.001). Conclusions Topical administration of lidocaine 2% gel or tetracaine 1 % drops are both effective anaesthetic agents for primary pterygium surgery and mitomycin C. However, lidocaine gel is superior to tetracaine eye drops and its application is more convenient with a less frequent application and a sustained duration of action.

Safety, efficacy, and patient acceptability of lidocaine hydrochloride ophthalmic gel as a topical ocular anesthetic for use in ophthalmic procedures

“…Eight studies addressed the use of lidocaine gel in cataract surgery, [6][7][8][9][10][11][12][13] 4 in pterygium surgery, [14][15][16][17] 2 in trabeculectomy/Ahmed valve implantation, 18,19 and 1 on phaco/trabeculectomy combination procedures. 20 There were 2 papers on lidocaine gel for intravitreal injection, 21,22 and 1 on vitrectomy.…”

“…Five RCTs compared lidocaine gel with control groups and reported the total number of additional anesthetic applications required for patient comfort during cataract extraction, 8,12 pterygium excision, 17 strabismus surgery, 25 and trabeculectomy. 19 Four of these 5 studies demonstrated that the use of lidocaine gel as the primary preoperative anesthetic resulted in a statistically significantly lower number of supplemental anesthetic applications required during surgery to maintain patient comfort (P  0.001 to  0.01).…”

A novel lidocaine hydrochloride ophthalmic gel for topical ocular anesthesia

“…Five of the 13 RCTs, including the randomized trial of Akten, revealed a statistically significantly lower pain score in the lidocaine gel group compared with other modalities of ocular anesthesia. Five RCTs compared the requirement for additional anesthetic applications for patient comfort, 8,11,23,24,32 and 4 of these demonstrated that lidocaine gel resulted in a statistically significantly lower number of supplemental anesthetic applications. 8,11,23,24 Two papers found significantly higher intracameral lidocaine levels in those receiving lidocaine gel than lidocaine drops.…”

“…Five RCTs compared the requirement for additional anesthetic applications for patient comfort, 8,11,23,24,32 and 4 of these demonstrated that lidocaine gel resulted in a statistically significantly lower number of supplemental anesthetic applications. 8,11,23,24 Two papers found significantly higher intracameral lidocaine levels in those receiving lidocaine gel than lidocaine drops. 7,12 In this review of ocular anesthesia, only the Akten trial described time to onset and duration of anesthesia in detail.…”

“…Akten 3.5% provided a longer duration of approximately 15 minutes. 20 Page et al recently evaluated the use of lidocaine hydrochloride ophthalmic gel in a literature review of 25 studies, including 15 prospective randomized controlled trials (RCT), 7,8,11,20,[23][24][25][26][27][28][29][30][31][32][33] 6 nonrandomized prospective studies, 2 animal studies, 1 microbiologic study, and 2 letters to the editor. Data from the 15 prospective RCTs are summarized in Table 1.…”