"Lignocaine vs GTN Ointment for Postoperative Pain After Hemorrhoidectomy")

NCT07159334 | Recruiting DMC

• 1 other identifier: Ahmad Rauf
• Study Type: interventional
• Target: 64
• Locations: 1 country
• Sites: 1

Brief Summary

This study is being conducted at the Department of General Surgery, King Edward Medical University, Lahore, Pakistan. The purpose of the trial is to compare the effectiveness of topical Lignocaine ointment versus topical Glyceryl Trinitrate (GTN) ointment in reducing postoperative pain following hemorrhoidectomy. Patients undergoing hemorrhoidectomy will be randomly assigned to receive either Lignocaine ointment or GTN ointment applied locally after surgery. Pain relief will be assessed using a visual analog scale (VAS) at regular intervals during the postoperative period. The study aims to determine which ointment provides better pain control and improves patient comfort during recovery.

Conditions

Hemorrhoid; Postoperative Pain

Keywords

Hemorrhoidectomy; Lignocaine ointment; Glyceryl Trinitrate ointment; Anal pain

Outcome Measures

Primary Outcomes (2)

• Postoperative pain score

  Pain intensity will be assessed using the Visual Analogue Scale (VAS), which ranges from 0 (no pain) to 10 (worst imaginable pain). Higher scores indicate greater pain severity.

  Up to 1 month postoperatively.

• Wound Healing Time

  Defined as the number of days from the date of surgery until complete wound healing (full epithelialization with no discharge or open area). Shorter duration indicates a better outcome.

  Up to 1 month postoperatively.

Secondary Outcomes (7)

• patient Satisfaction Level

  6 weeks postoperatively

• Time to Request of First Analgesic Dose

  Within 24 hours postoperatively

• Amount of Analgesia Administered in First 24 Hours

  0-24 hours postoperatively

• Incidence of Wound Secretion

  1 month postoperatively

• Incidence of Itching

  1 month postoperatively

Study Arms (2)

1.Lignocaine Ointment Group

EXPERIMENTAL

Participants will receive topical lignocaine ointment applied to the anal wound post-hemorrhoidectomy for pain control.

Drug: Lignocaine Ointment; Drug: Glyceryl Trinitrate Ointment 0.2%

Glyceryl Trinitrate Ointment Group

EXPERIMENTAL

Participants will receive topical 0.2% glyceryl trinitrate ointment applied to the anal wound post-hemorrhoidectomy for pain control.

Drug: Lignocaine Ointment; Drug: Glyceryl Trinitrate Ointment 0.2%

Interventions

Lignocaine Ointment DRUG

Applied to the anal wound three time daily after hemorrhoidectomy.

1.Lignocaine Ointment Group; Glyceryl Trinitrate Ointment Group

Glyceryl Trinitrate Ointment 0.2% DRUG

Applied to the anal wound three time daily after hemorrhoidectomy.

1.Lignocaine Ointment Group; Glyceryl Trinitrate Ointment Group

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Age between 18 - 60 years
• Both genders
• Grade III and IV hemorrhoids diagnosed on the basis of history and clinical examination by consultant Surgeon.(Grade III Hemorrhoid manually reduced by patient with finger and Grade IV is prolapsed)
• ASA (American society of Anesthesia) grades I, and II

You may not qualify if:

• Previously reported allergy or reaction to lignocaine and GTN
• Pregnancy or lactation
• Concomitant perianal pathology warranting surgery
• Cardiovascular disease
• Patient taking Nitrates or Calcium channel blocker

Sponsors & Collaborators

• King Edward Medical University: lead

Study Sites (1)

King Edward Medical uUniveristy Mayo Hospital

Lahore, Punjab Province, 54000, Pakistan

RECRUITING

MeSH Terms

Conditions

Hemorrhoids; Pain, Postoperative

Condition Hierarchy (Ancestors)

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

Study Officials

• Hafiz Ahmad Rauf

  King Edward Medical University/Mayo hospital Lahore

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Hafiz Ahmad Rauf, Mbbs,Fcps

CONTACT

+923006023465; ahmadrauf498@gmail.com

KEMU/ Mayo Hospital lahore

CONTACT

+924299214819; info@kemu.edu.pk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: "Participants will be randomized into two parallel groups: one receiving topical lignocaine ointment and the other receiving topical glyceryl trinitrate ointment for postoperative pain management after hemorrhoidectomy."

Study Record Dates

• First Submitted: August 21, 2025
• First Posted: September 8, 2025
• Study Start: August 2, 2025
• Primary Completion: December 1, 2025
• Study Completion: December 1, 2025
• Last Updated: September 8, 2025

Record last verified: 2025-09

Locations

PA (1)