2% Lidocaine Gel in Reducing Postoperative Pain Following Haemorrhoidectomy

NCT06420388 | Recruiting

• 1 other identifier: EMRP28112N
• Study Type: interventional
• Target: 400
• Locations: 1 country
• Sites: 1

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.

Conditions

Surgery; Pain, Postoperative

Keywords

hemorrhoids; pain management

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Lidocaine Gel

EXPERIMENTAL

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; Drug: Standard Postoperative Analgesics

Controlled

PLACEBO COMPARATOR

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: Water-based Lubricant Gel (K-Y Gel); Drug: Standard Postoperative Analgesics

Interventions

2% Lidocaine Gel 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.

Lidocaine Gel

Water-based Lubricant Gel (K-Y Gel) 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.

Controlled

Standard Postoperative Analgesics 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; Lidocaine Gel

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• E-DA Hospital: lead

Study Sites (1)

E-Da hospital

Kaohsiung City, 812, Taiwan

RECRUITING

MeSH Terms

Conditions

Pain, Postoperative; Hemorrhoids; Agnosia

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms; Rectal Diseases; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Vascular Diseases; Cardiovascular Diseases; Perceptual Disorders; Neurobehavioral Manifestations; Nervous System Diseases

Study Officials

• Chen Chih-I

  E-DA Hospital

  STUDY DIRECTOR

Central Study Contacts

Chen Chih-i

CONTACT

+886978060015; ed111988@edah.org.tw

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: This study employed a double-blind masking approach to minimize potential bias. Patients, surgeons, and outcome assessors were blinded to treatment allocation. The randomization scheme was generated by a third party not involved in patient care, and sealed envelopes containing the allocation were opened only after the haemorrhoidectomy procedure was completed. The study gels were packaged identically to maintain blinding. Unblinding occurred only after data analysis was completed. This double-blind design ensured that knowledge of treatment allocation did not influence postoperative care, patient-reported pain scores, or the assessment of outcomes.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: May 12, 2024
• First Posted: May 20, 2024
• Study Start: May 1, 2023
• Primary Completion: July 1, 2024
• Study Completion: October 1, 2024
• Last Updated: June 12, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: 1 year

Locations

TW (1)