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

ConditionsHemorrhoidPostoperative Pain
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-60
SponsorKing Edward Medical University

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

Previously reported allergy or reaction to lignocaine and GTN

Pregnancy or lactation

Concomitant perianal pathology warranting surgery

Cardiovascular disease

Trial design

Design model

Parallel

Treatments tested in this trial

  • Lignocaine Ointment

    Drug

    Applied to the anal wound three time daily after hemorrhoidectomy.

  • Glyceryl Trinitrate Ointment 0.2%

    Drug

    Applied to the anal wound three time daily after hemorrhoidectomy.

Treatment groups

64 Participants
are divided into 2 treatment groups
Group A: 1.Lignocaine Ointment GroupExperimental treatment 2 interventions
Group B: Glyceryl Trinitrate Ointment GroupExperimental treatment 2 interventions

Trial outcomes

Primary outcomes

1

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.

Time frame
Up to 1 month postoperatively.
2

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.

Time frame
Up to 1 month postoperatively.

Secondary outcomes

1

patient Satisfaction Level

Overall satisfaction with postoperative care and treatment, assessed using a 5-point Likert scale (1 = very dissatisfied, 5 = very satisfied). Higher scores indicate greater satisfaction.

Time frame
6 weeks postoperatively
2

Time to Request of First Analgesic Dose

Time (in minutes/hours) from end of surgery to first request for analgesia. Shorter time indicates earlier need for pain control.

Time frame
Within 24 hours postoperatively
3

Amount of Analgesia Administered in First 24 Hours

Total rescue analgesic dose administered in first 24 hours, recorded in mg (converted to morphine-equivalent dose if applicable). Lower values indicate better pain control.

Time frame
0-24 hours postoperatively
4

Incidence of Wound Secretion

Presence of wound secretion (yes/no) as noted on clinical examination.

Time frame
1 month postoperatively

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

King Edward Medical University

Lead sponsor

Source ClinicalTrials.gov
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