Clinical trial NCT06420388: 2% Lidocaine Gel in Reducing Postoperative Pain Following Haemorrhoidectomy
Official title: Efficacy of 2% Lidocaine Gel in Reducing Postoperative Pain and Analgesic Consumption Following Haemorrhoidectomy: A Randomized, Double-Blind, Controlled Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Surgery
Pain, Postoperative
Keywords: hemorrhoids
pain management
Lead sponsor: E-DA Hospital
Sponsor class: OTHER
First posted: 2024-05-20
Enrollment: 400
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This study is a single-center, randomized, double-blind, controlled clinical trial comparing the efficacy of 2% lidocaine gel versus a non-anaesthetic lubricant gel control in reducing postoperative pain and analgesic consumption following haemorrhoidectomy. Patients were randomly assigned in a 1:1 ratio to either the intervention group receiving 5 mL 2% lidocaine gel three times per day postoperatively or the control group receiving 5 mL of a non-anaesthetic water-based lubricant gel.
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Postoperative pain
timeFrame: Assessed at 12 hours, 24 hours, 2 days, 3 days, and 7 days after surgery
Secondary outcomes:
Other outcomes:
Locations:
city: Kaohsiung
country: Taiwan
facility: E-Da hospital
Study officials:
affiliation: E-DA Hospital
name: Chen Chih-I
role: STUDY_DIRECTOR
References: