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

King Edward Medical University

Status: Enrolling

Conditions: Postoperative Pain; Hemorrhoid

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

Study type: Interventional

Funder types: Other

Identifiers

NCT07159334

Ahmad Rauf

Details and patient eligibility

About

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.

Full description

This study aims to compare the effectiveness of lignocaine versus 0.2% glyceryl trinitrate (GTN) ointment as postoperative analgesics in patients who have undergone hemorrhoidectomy.

Background

Hemorrhoids are swollen veins in the anal region, commonly treated through Milligan-Morgan hemorrhoidectomy. Postoperative pain is a major concern, affecting mobility and delaying recovery.

Various treatments have been explored to alleviate post-hemorrhoidectomy pain, including anal dilatation, NSAIDs, opioids, and topical treatments like nifedipine, botulinum toxin, lignocaine, and GTN ointment.

Both GTN and lignocaine have been shown to reduce pain, but the most effective and safe option is still unclear.

Study Objective

To compare the outcomes of lignocaine versus 0.2% GTN ointment in reducing pain and promoting wound healing in post-hemorrhoidectomy patients.

Hypothesis

There is a difference in the pain relief and wound healing outcomes between lignocaine and GTN ointment in hemorrhoidectomy patients.

Study Design

Randomized clinical trial conducted at the Department of Surgery, Mayo Hospital, Lahore.

Duration: 3-6 months after synopsis approval.

Sample Size: 64 patients (32 in each group).

Inclusion Criteria: Age 18-60, both genders, Grade III/IV hemorrhoids, ASA grades I & II.

Exclusion Criteria: Allergies to lignocaine or GTN, pregnancy, concomitant perianal pathology, cardiovascular issues, use of nitrates or calcium channel blockers.

Methods

Participants will undergo hemorrhoidectomy under spinal anesthesia/saddle block/general anesthesia.

Group A will receive lignocaine cream, and Group B will receive 0.2% GTN ointment post-operatively (applied 3 times daily).

Both groups will receive standard postoperative care (sitz baths, stool softeners, and paracetamol for pain).

Outcome Measures:

Pain Score using Visual Analogue Scale (VAS) at various time points (6, 12, 24, 48, 72 hours; 7, 14, 21, and 28 days post-surgery).

Time to complete wound healing (measured in days).

Level of patient satisfaction after 6 weeks using a 5-point Likert scale.

Data Analysis

Data will be analyzed using SPSS. Descriptive statistics for quantitative variables (e.g., age, pain scores) and qualitative variables (e.g., gender, patient satisfaction).

Independent t-tests will be used to compare outcomes between groups. A p-value < 0.05 will be considered statistically significant.

Patient Follow-Up

Patients will be followed for 6 weeks post-surgery to monitor pain levels, wound healing, and satisfaction.

Conclusion

This trial aims to determine which topical analgesic-lignocaine or GTN ointment-is more effective for postoperative pain management and wound healing in hemorrhoidectomy patients.

Enrollment: 64 estimated patients

Sex: All

Ages: 18 to 60 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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

Exclusion criteria

• 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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64 participants in 2 patient groups

1.Lignocaine Ointment Group

Experimental group

Description:

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

Treatment:

Drug: Glyceryl Trinitrate Ointment 0.2%

Drug: Lignocaine Ointment

Glyceryl Trinitrate Ointment Group

Experimental group

Description:

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

Treatment:

Drug: Glyceryl Trinitrate Ointment 0.2%

Drug: Lignocaine Ointment