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2% Lidocaine Gel in Reducing Postoperative Pain Following Haemorrhoidectomy

NCT06420388 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 400

Last updated 2024-06-12

No results posted yet for this study

Summary

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.

Conditions

  • Surgery
  • Pain, Postoperative

Interventions

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

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.

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 cyclooxygenase-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

Sponsors & Collaborators

  • E-DA Hospital

    lead OTHER

Principal Investigators

  • Chen Chih-I · E-DA Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-05-01
Primary Completion
2024-07-01
Completion
2024-10-01

Countries

  • Taiwan

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06420388 on ClinicalTrials.gov