Topical Lidocaine 23%/Tetracaine 7% Ointment for Post-Hemorrhoidectomy Analgesia: A Randomized Controlled Trial

Summary

The goal of this clinical trial is to learn if a topical ointment containing two local anesthetics (lidocaine 23% and tetracaine 7%) can reduce pain after hemorrhoid surgery in adults. The main questions it aims to answer are: * Does the ointment lower post-defecation pain movements in the first 10 days after surgery? * Does the ointment lower overall daily pain in the 10 days after surgery? * Does the ointment reduce the need for rescue pain medication (tramadol)? Researchers will compare the lidocaine/tetracaine ointment to a placebo (a look-alike ointment that contains no active drug) to see if the active ointment works better to reduce pain after hemorrhoid surgery. Participants will: * Apply the ointment or placebo to the anal area every 12 hours for 10 days after surgery * Rate their pain on a scale from 0 to 10 each day, including pain after bowel movements/defecation * Record how many times they take rescue pain medication each day * Receive check-in calls/mesages from the research team after surgery

Timeline

Start

2023-05-24

Primary completion

2025-10-09

Completion

2026-05-12

Publications

• Background Bikfalvi A, Faes C, Freys SM, Joshi GP, Van de Velde M, Albrecht E. PROSPECT guideline for haemorrhoid surgery: A systematic review and procedure-specific postoperative pain management recommendations. Eur J Anaesthesiol Intensive Care. 2023 May 26;2(3):e0023. doi: 10.1097/EA9.0000000000000023. eCollection 2023 Jun.
• Background Chen H, Zhang W, Sun Y, Jiao R, Liu Z. The Role of Acupuncture in Relieving Post-Hemorrhoidectomy Pain: A Systematic Review of Randomized Controlled Trials. Front Surg. 2022 Mar 28;9:815618. doi: 10.3389/fsurg.2022.815618. eCollection 2022.
• Background Hatami M, Talebi M, Heiranizadeh N, Vaziribozorg S. The Effect of Perianal Tramadol Infiltration on Postoperative Pain Following Hemorrhoidectomy. Am Surg. 2022 Jan;88(1):98-102. doi: 10.1177/0003134820981683. Epub 2020 Dec 28.
• Background Hopewell S, Chan AW, Collins GS, Hrobjartsson A, Moher D, Schulz KF, Tunn R, Aggarwal R, Berkwits M, Berlin JA, Bhandari N, Butcher NJ, Campbell MK, Chidebe RCW, Elbourne D, Farmer A, Fergusson DA, Golub RM, Goodman SN, Hoffmann TC, Ioannidis JPA, Kahan BC, Knowles RL, Lamb SE, Lewis S, Loder E, Offringa M, Ravaud P, Richards DP, Rockhold FW, Schriger DL, Siegfried NL, Staniszewska S, Taylor RS, Thabane L, Torgerson D, Vohra S, White IR, Boutron I. CONSORT 2025 statement: updated guideline for reporting randomised trials. BMJ. 2025 Apr 14;389:e081123. doi: 10.1136/bmj-2024-081123.
• Background McCleskey PE, Patel SM, Mansalis KA, Elam AL, Kinsley TR. Serum lidocaine levels and cutaneous side effects after application of 23% lidocaine 7% tetracaine ointment to the face. Dermatol Surg. 2013 Jan;39(1 Pt 1):82-91. doi: 10.1111/dsu.12064. Epub 2012 Dec 26.
• Background Linares-Gil MJ, Valls J, Hereu-Boher P, Nebot FJ, De-Ramon B, Diaz-Munio E, Sanzol R, De-Oca J, Perez-Lozano P, Sune-Negre JM, Garcia-Montoya E. Topical Analgesia with Lidocaine Plus Diclofenac Decreases Pain in Benign Anorectal Surgery: Randomized, Double-blind, and Controlled Clinical Trial. Clin Transl Gastroenterol. 2018 Nov 23;9(11):210. doi: 10.1038/s41424-018-0075-7.
• Background Khan KI, Waqas A, Akmal M, Mahmood S, Iqbal A. Efficacy of combination of 0.2% GTN and lignocaine ointments in wound healing and pain relief after Milligan Morgan hemorrhoidectomy--a comparison with lignocaine and 0.2% GTN ointments separately. Int J Surg. 2014;12(4):329-33. doi: 10.1016/j.ijsu.2014.01.013. Epub 2014 Jan 29.
• Background Shiau JM, Su HP, Chen HS, Hung KC, Lin SE, Tseng CC. Use of a topical anesthetic cream (EMLA) to reduce pain after hemorrhoidectomy. Reg Anesth Pain Med. 2008 Jan-Feb;33(1):30-5. doi: 10.1016/j.rapm.2007.07.012.
• Background Rahimi M, Kazemeini AR, Pourtabatabaei N, Honarmand AR. Comparison of topical anesthetic cream (EMLA) and diclofenac suppository for pain relief after hemorrhoidectomy: a randomized clinical trial. Surg Today. 2012 Dec;42(12):1201-5. doi: 10.1007/s00595-012-0222-9. Epub 2012 Jun 19.
• Background Xia W, Barazanchi AWH, MacFater WS, MacCormick AD, Svirskis D, Sammour T, Hill AG. Topical Versus Oral Metronidazole After Excisional Hemorrhoidectomy: A Double-Blind Randomized Controlled Trial. Dis Colon Rectum. 2022 Nov 1;65(11):1362-1372. doi: 10.1097/DCR.0000000000002163. Epub 2021 Dec 9.
• Background Sugimoto T, Tsunoda A, Kano N, Kashiwagura Y, Hirose K, Sasaki T. A randomized, prospective, double-blind, placebo-controlled trial of the effect of diltiazem gel on pain after hemorrhoidectomy. World J Surg. 2013 Oct;37(10):2454-7. doi: 10.1007/s00268-013-2124-4.
• Background Xia W, Park B, Otutaha BF, MacFater WS, MacCormick AD, Sammour T, Hill AG. Topical analgesia following excisional haemorrhoidectomy: a systematic review and meta-analysis of randomised controlled trials. Int J Colorectal Dis. 2020 Feb;35(2):181-197. doi: 10.1007/s00384-019-03497-7. Epub 2020 Jan 2.
• Background Sammour T, Barazanchi AW, Hill AG; PROSPECT group (Collaborators). Evidence-Based Management of Pain After Excisional Haemorrhoidectomy Surgery: A PROSPECT Review Update. World J Surg. 2017 Feb;41(2):603-614. doi: 10.1007/s00268-016-3737-1.
• Background Lohsiriwat V, Jitmungngan R, Chadbunchachai W, Ungprasert P. Enhanced recovery after surgery in emergency resection for obstructive colorectal cancer: a systematic review and meta-analysis. Int J Colorectal Dis. 2020 Aug;35(8):1453-1461. doi: 10.1007/s00384-020-03652-5. Epub 2020 Jun 22.
• Background Van Backer JT, Jordan MR, Leahy DT, Moore JS, Callas P, Dominick T, Cataldo PA. Preemptive Analgesia Decreases Pain Following Anorectal Surgery: A Prospective, Randomized, Double-Blinded, Placebo-Controlled Trial. Dis Colon Rectum. 2018 Jul;61(7):824-829. doi: 10.1097/DCR.0000000000001069.
• Background Mongelli F, Treglia G, La Regina D, Di Giuseppe M, Galafassi J, Majno-Hurst PE, Christoforidis D. Pudendal Nerve Block in Hemorrhoid Surgery: A Systematic Review and Meta-analysis. Dis Colon Rectum. 2021 May;64(5):617-631. doi: 10.1097/DCR.0000000000001985.
• Background Ceulemans A, De Looze D, Van de Putte D, Stiers E, Coppens M. High post-operative pain scores despite multimodal analgesia in ambulatory anorectal surgery: a prospective cohort study. Acta Chir Belg. 2019 Aug;119(4):224-230. doi: 10.1080/00015458.2018.1500802. Epub 2018 Sep 7.
• Background Davis BR, Lee-Kong SA, Migaly J, Feingold DL, Steele SR. The American Society of Colon and Rectal Surgeons Clinical Practice Guidelines for the Management of Hemorrhoids. Dis Colon Rectum. 2018 Mar;61(3):284-292. doi: 10.1097/DCR.0000000000001030. No abstract available.

Drugs

Indications