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

NCT07688031 | Completed Phase 4

• 1 other identifier: 220531005
• Study Type: interventional
• Target: 74
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

Pain Management; Hemorrhoids Third Degree; Hemorrhoids Fourth Degree; Hemorrhoids Second Degree

Keywords

Hemorrhoidectomy; Postoperative pain; Topical analgesia; Lidocaine; Opioid-sparing; Anorectal surgery; Pain management

Outcome Measures

Primary Outcomes (1)

• Post-defecatory pain score during the first 10 postoperative days

  Self-reported post-defecatory pain intensity assessed using a 0-10 visual analogue scale (VAS), recorded by participants immediately after each bowel movement. The primary outcome is the mean of available daily post-defecatory VAS scores across postoperative days 1 through 10. On days with more than one bowel movement, the daily score represents the mean of all recordings. Days without a bowel movement are excluded from the calculation.

  Postoperative days 1 through 10

Secondary Outcomes (6)

• Mean daily pain score

  Postoperative days 1 through 10

• Cumulative rescue opioid consumption

  Postoperative days 1 through 10

• Adverse effects related to the study ointment

  Postoperative days 0 through 10

• Postoperative complications within 30 days

  30 days postoperatively

• Mean post-defecatory pain score during postoperative days 1-5

  Postoperative days 1 through 5

Study Arms (2)

Lidocaine/Tetracaine Ointment

EXPERIMENTAL

Participants applied approximately 2 g of compounded lidocaine 23%/tetracaine 7% ointment to the perianal area every 12 hours, beginning on the day of surgery (postoperative day 0) and continuing through postoperative day 10. All participants also received a standardized perioperative analgesic protocol consisting of scheduled oral ketorolac and acetaminophen, with oral tramadol 25 mg per dose available on demand as rescue analgesia.

Drug: Lidocaine 23% / Tetracaine 7% topical ointment (compounded)

Placebo

PLACEBO COMPARATOR

Participants applied an identical-appearing placebo ointment to the perianal area every 12 hours following the same schedule as the intervention group (postoperative days 0 to 10). The placebo was prepared by the same independent compounding pharmacy and was identical in color, texture, and packaging to the active ointment. All participants also received the same standardized perioperative analgesic protocol consisting of scheduled oral ketorolac and acetaminophen, with oral tramadol 25 mg per dose available on demand as rescue analgesia.

Other: Placebo ointment

Interventions

Lidocaine 23% / Tetracaine 7% topical ointment (compounded) DRUG

Compounded topical ointment containing lidocaine 23% and tetracaine 7%, prepared by an independent compounding pharmacy. Approximately 2 g applied to the perianal area every 12 hours from postoperative day 0 through day 10.

Lidocaine/Tetracaine Ointment

Placebo ointment OTHER

Inert topical ointment identical in appearance, color, texture, and packaging to the active intervention, prepared by the same independent compounding pharmacy. Applied following the same schedule as the active ointment

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 18 years or older
• Scheduled for elective hemorrhoidectomy
• Recruited consecutively on the day of surgery
• Able to provide written informed consent

You may not qualify if:

• Inflammatory bowel disease
• Immunosuppression
• Pregnancy
• Chronic pain requiring ongoing analgesic treatment
• Known hypersensitivity to any of the study medications
• Significant cardiovascular disease
• Peripheral vascular disease
• Cerebrovascular disease
• Hepatic disease
• Seizure disorders

Sponsors & Collaborators

• Sociedad Chilena de Coloproctología: collaborator
• Pontificia Universidad Catolica de Chile: lead

Study Sites (1)

Red UC Christus Hospital

Santiago, RM, Chile

Location

Related Publications (18)

• 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.

  PMID: 39917290 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.

  PMID: 35419404 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.

  PMID: 33371715 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.

  PMID: 40228833 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.

  PMID: 23278914 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.

  PMID: 30467335 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.

  PMID: 24486687 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.

  PMID: 18155054 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.

  PMID: 22711185 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.

  PMID: 34897211 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.

  PMID: 23775515 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.

  PMID: 31897645 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.

  PMID: 27766395 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.

  PMID: 32572602 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.

  PMID: 29771804 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.

  PMID: 33591044 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.

  PMID: 30189793 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.

  PMID: 29420423 BACKGROUND

MeSH Terms

Conditions

Agnosia; Pain, Postoperative

Interventions

Lidocaine; Tetracaine; Ointments

Condition Hierarchy (Ancestors)

Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Postoperative Complications; Pathologic Processes; Pain

Intervention Hierarchy (Ancestors)

Acetanilides; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; para-Aminobenzoates; Aminobenzoates; Benzoates; Acids, Carbocyclic; Carboxylic Acids; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Dosage Forms; Pharmaceutical Preparations

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Masking Details: Statistical analysis was performed while the investigative team remained blinded to group allocation, with groups identified only as "Group A" and "Group B". Treatment allocation was revealed only after the analysis was complete and the results had been interpreted.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr.

Study Record Dates

• First Submitted: June 30, 2026
• First Posted: July 7, 2026
• Study Start: May 24, 2023
• Primary Completion: October 9, 2025
• Study Completion: May 12, 2026
• Last Updated: July 7, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share

Locations

CL (1)