2% Lidocaine Gel in Reducing Postoperative Pain Following Haemorrhoidectomy

E-DA Hospital

Status: Enrolling

Conditions: Surgery; Pain, Postoperative

Treatments: Drug: 2% Lidocaine Gel; Drug: Standard Postoperative Analgesics; Drug: Water-based Lubricant Gel (K-Y Gel)

Study type: Interventional

Funder types: Other

Identifiers

NCT06420388

EMRP28112N

Details and patient eligibility

About

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.

Full 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.

Enrollment: 400 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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400 participants in 2 patient groups, including a placebo group

Lidocaine Gel

Experimental group

Description:

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

Treatment:

Drug: Standard Postoperative Analgesics

Drug: 2% Lidocaine Gel

Controlled

Placebo Comparator group

Description:

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

Treatment:

Drug: Water-based Lubricant Gel (K-Y Gel)

Drug: Standard Postoperative Analgesics