2% Lidocaine Gel in Reducing Postoperative Pain Following Haemorrhoidectomy

NCT ID: NCT06420388

Last Updated: 2024-06-12

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 400 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-05-01
• Study Completion Date: 2024-10-01

Brief 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.

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.

Study Design: This study is a single-center, randomized, double-blind, controlled trial. Patients will be randomly assigned in a 1:1 ratio to receive either 2% lidocaine gel or a non-anaesthetic water-based lubricant gel (control) using a computer-generated randomization list. The randomization will be stratified by hemorrhoid grade (III or IV). The study medication will be prepared by the hospital pharmacy and provided in identical, pre-filled syringes to ensure blinding of participants and investigators.

Intervention: The intervention group will receive 5 mL of 2% lidocaine gel, while the control group will receive 5 mL of a non-anaesthetic water-based lubricant gel. The study medication will be applied to the perianal region three times per day for 7 days following surgery. Patients will be instructed on the proper application technique and will be provided with a diary to record the time and date of each application.

Outcome Assessment: Postoperative pain will be assessed using a 100 mm visual analog scale (VAS), with 0 representing no pain and 100 representing the worst imaginable pain. Pain scores will be recorded at 12 and 24 hours, and 2, 3, and 7 days after surgery. Patients will also record their analgesic consumption in a diary, including the type, dose, and frequency of analgesics used. Postoperative complications, such as bleeding, infection, or urinary retention, will be assessed by the treating surgeon at each follow-up visit.

Sample Size: A sample size of 222 patients (111 per group) was calculated based on a power of 80%, a significance level of 0.05, and an expected difference in mean VAS scores of 15 mm between the groups, with a standard deviation of 30 mm.

Conditions

Surgery; Pain, Postoperative

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

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

Group Type: EXPERIMENTAL

2% Lidocaine Gel

Intervention Type: DRUG

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.

Standard Postoperative Analgesics

Intervention Type: DRUG

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

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

Group Type: PLACEBO_COMPARATOR

Water-based Lubricant Gel (K-Y Gel)

Intervention Type: DRUG

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.

Standard Postoperative Analgesics

Intervention Type: DRUG

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

Interventions

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.

Intervention Type: 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.

Intervention Type: 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

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

E-DA Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Chen Chih-I

Role: STUDY_DIRECTOR

E-DA Hospital

Locations

E-Da hospital

Kaohsiung City, , Taiwan

Site Status: RECRUITING

Countries

Taiwan

Central Contacts

Chen Chih-i

Role: CONTACT

ed111988@edah.org.tw

+886978060015

Facility Contacts

Chen Chih-I

Role: primary

ed111988@edah.org.tw

+886978060015

Other Identifiers

EMRP28112N

Identifier Type: -

Identifier Source: org_study_id