2% Lidocaine Gel in Reducing Postoperative Pain Following Haemorrhoidectomy

Efficacy of 2% Lidocaine Gel in Reducing Postoperative Pain and Analgesic Consumption Following Haemorrhoidectomy: A Randomized, Double-Blind, Controlled Trial

The study is a randomized, double-blind, controlled trial evaluating the efficacy of 2% lidocaine gel in reducing postoperative pain and analgesic consumption after haemorrhoidectomy. 222 patients undergoing Ferguson haemorrhoidectomy will be randomly assigned to receive either 2% lidocaine gel or a non-anaesthetic lubricant gel control. Pain scores using a visual analog scale (VAS) will be assessed at 12 and 24 hours, and 2, 3, and 7 days postoperatively. Analgesic consumption will also be measured.

Study Overview

• Status: Recruiting
• Conditions: Pain, Postoperative; Surgery
• Intervention / Treatment: Drug: 2% Lidocaine Gel; Drug: Standard Postoperative Analgesics; Drug: Water-based Lubricant Gel (K-Y Gel)

Detailed Description

Title: Efficacy of 2% Lidocaine Gel in Reducing Postoperative Pain and Analgesic Consumption Following Haemorrhoidectomy: A Randomized, Double-Blind, Controlled Trial Objective: To assess the effect of 2% lidocaine gel on postoperative pain intensity and analgesic consumption following haemorrhoidectomy.

Endpoints:

Primary: Postoperative pain measured using a VAS at 12 and 24 hours and 2, 3, and 7 days after surgery Secondary: Analgesic consumption and postoperative complications

Intervention:

Intervention group: 5 mL 2% lidocaine gel three times per day postoperatively Control group: 5 mL non-anaesthetic water-based lubricant gel

Key eligibility criteria:

Inclusion: Age ≥18 years, Grade III-IV haemorrhoids, candidate for Ferguson haemorrhoidectomy Exclusion: Not a candidate for Ferguson haemorrhoidectomy, recurrent hemorrhoidal disease, concurrent anal pathology, history of diabetes/liver disease/IBD/neuropathy/coagulopathy, on anticoagulants, allergy to study drugs

Planned statistical analyses:

Descriptive statistics will be used for qualitative and quantitative variables. Chi-square test, Student's t-test, and ANOVA will be used depending on the nature of the data. A p-value <0.05 will be considered statistically significant.

• Study Type: Interventional
• Enrollment (Estimated): 400
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Chen Chih-I; Phone Number: +886978060015; Email: ed111988@edah.org.tw

Study Locations

• Taiwan
  • Kaohsiung, Taiwan, 812
    • Recruiting
    • E-DA hospital
    • Contact: Chen Chih-I; Phone Number: +886978060015; Email: ed111988@edah.org.tw

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Age 18 years or older
• Diagnosed with Grade III or IV hemorrhoids
• Candidate for Ferguson haemorrhoidectomy

Exclusion Criteria:

• Not a candidate for Ferguson haemorrhoidectomy
• Recurrent hemorrhoidal disease
• Concurrent anal pathology diagnosed preoperatively, including:
• Anal fistula
• Anal fissure
• Anal polyp
• History of diabetes mellitus
• History of liver cirrhosis
• History of inflammatory bowel disease
• Documented neuropathy
• Coagulation disorders
• Currently on anticoagulants
• Documented allergy to any of the drugs included in the protocol

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Lidocaine Gel; Description: Patients in this group received 5 mL of 2% lidocaine gel applied to the perianal region three times per day postoperatively. The gel was self-administered by the patient or applied by a nurse if the patient was unable to do so. Treatment continued for 7 days after the haemorrhoidectomy procedure. Arm Sample Size: 200	Drug: 2% Lidocaine Gel; The intervention group received 5 mL of 2% lidocaine gel applied topically 3 times per day after undergoing Ferguson hemorrhoidectomy surgery. The control group received 5 mL of a non-anesthetic water-based lubricant gel applied topically 3 times per day after surgery. The application of the gels began immediately after surgery and continued for the postoperative period evaluated in the study. Both groups received standard postoperative analgesics (acetaminophen, celecoxib, Dynastat/parecoxib as needed) in addition to the topical gel applications.; Drug: Standard Postoperative Analgesics; Acetaminophen (Paracetamol) Dosage: 500 mg per tablet Frequency: Every 6 hours Route: Oral Acetaminophen is a common over-the-counter pain reliever and fever reducer. It works by blocking the production of prostaglandins, which are responsible for causing pain and inflammation. Celecoxib Dosage: 200 mg per tablet Frequency: Every 12 hours Route: Oral Celecoxib is a nonsteroidal anti-inflammatory drug (NSAID) that specifically inhibits the COX-2 enzyme. By reducing the production of prostaglandins, celecoxib helps alleviate pain and inflammation. Dynastat (Parecoxib) Dosage: 40 mg per injection Frequency: Every 12 hours as needed for poorly controlled pain Route: Intravenous
Placebo Comparator: Controlled; Description: Patients in this group received 5 mL of a non-anaesthetic, water-based lubricant gel (K-Y gel) applied to the perianal region three times per day postoperatively. The gel was self-administered by the patient or applied by a nurse if the patient was unable to do so. Treatment continued for 7 days after the haemorrhoidectomy procedure. This group served as a control to compare the efficacy of 2% lidocaine gel in reducing postoperative pain and analgesic consumption. Arm Sample Size: 200	Drug: Standard Postoperative Analgesics; Acetaminophen (Paracetamol) Dosage: 500 mg per tablet Frequency: Every 6 hours Route: Oral Acetaminophen is a common over-the-counter pain reliever and fever reducer. It works by blocking the production of prostaglandins, which are responsible for causing pain and inflammation. Celecoxib Dosage: 200 mg per tablet Frequency: Every 12 hours Route: Oral Celecoxib is a nonsteroidal anti-inflammatory drug (NSAID) that specifically inhibits the COX-2 enzyme. By reducing the production of prostaglandins, celecoxib helps alleviate pain and inflammation. Dynastat (Parecoxib) Dosage: 40 mg per injection Frequency: Every 12 hours as needed for poorly controlled pain Route: Intravenous; Drug: Water-based Lubricant Gel (K-Y Gel); The intervention group received 5 mL of mL of a non-anesthetic water-based lubricant gel (K-Y gel) applied topically 3 times per day after undergoing Ferguson hemorrhoidectomy surgery.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Postoperative pain	Postoperative pain measured by Visual Analog Scale (VAS) The Visual Analog Scale (VAS) is a unidimensional measure of pain intensity. Patients mark their pain level on a 10-cm line, where 0 represents "no pain" and 10 represents "the worst pain imaginable". Higher scores indicate greater pain intensity.	Assessed at 12 hours, 24 hours, 2 days, 3 days, and 7 days after surgery

Collaborators and Investigators

• Sponsor: E-DA Hospital
• Investigators: Study Director: Chen Chih-I, E-DA hospital

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2023
• Primary Completion (Estimated): July 1, 2024
• Study Completion (Estimated): October 1, 2024

Study Registration Dates

• First Submitted: May 12, 2024
• First Submitted That Met QC Criteria: May 16, 2024
• First Posted (Actual): May 20, 2024

Study Record Updates

• Last Update Posted (Actual): May 20, 2024
• Last Update Submitted That Met QC Criteria: May 16, 2024
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Keywords: pain management; hemorrhoids
• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Pain; Neurologic Manifestations; Pain, Postoperative; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Anti-Arrhythmia Agents; Central Nervous System Depressants; Peripheral Nervous System Agents; Sensory System Agents; Anesthetics; Membrane Transport Modulators; Anesthetics, Local; Voltage-Gated Sodium Channel Blockers; Sodium Channel Blockers; Lidocaine; Analgesics
• Other Study ID Numbers: EMRP28112N

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: The study is a randomized, double-blind, controlled trial evaluating the efficacy of 2% lidocaine gel in reducing postoperative pain and analgesic consumption after haemorrhoidectomy. 222 patients undergoing Ferguson haemorrhoidectomy were randomly assigned to receive either 2% lidocaine gel or a non-anaesthetic lubricant gel control. Pain scores using a visual analog scale (VAS) were assessed at 12 and 24 hours, and 2, 3, and 7 days postoperatively. Analgesic consumption was also measured.
• IPD Sharing Time Frame: 1 year
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No