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NCT Number: NCT07159334

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

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.

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Key information

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

King Edward Medical uUniveristy Mayo Hospital

Lahore, Punjab Province, 54000, Pakistan

Location status: Recruiting

Location contact

Hafiz Ahmad Rauf, Mbbs

CONTACT

[email protected]

+923006023465

Hafiz Ahmad Rauf, Mbbs

PRINCIPAL_INVESTIGATOR

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. Postoperative pain score

    Time frame: Up to 1 month postoperatively.

    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.

  2. Wound Healing Time

    Time frame: Up to 1 month postoperatively.

    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.

Secondary outcomes

  1. patient Satisfaction Level

    Time frame: 6 weeks postoperatively

    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.

  2. Time to Request of First Analgesic Dose

    Time frame: Within 24 hours postoperatively

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

  3. Amount of Analgesia Administered in First 24 Hours

    Time frame: 0-24 hours postoperatively

    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.

  4. Incidence of Wound Secretion

    Time frame: 1 month postoperatively

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

  5. Incidence of Itching

    Time frame: 1 month postoperatively

    Patient-reported pruritus at wound site (yes/no)

  6. Incidence of Postoperative Bleeding

    Time frame: 1 month postoperatively

    Occurrence of wound bleeding postoperatively (yes/no).

  7. Incidence and Severity of Headache

    Time frame: 1 month postoperatively

    Patient-reported headache severity measured using a Numerical Rating Scale (0 = no headache, 10 = worst imaginable).

Study contacts

Contact information is provided by the study sponsor or research team.

Hafiz Ahmad Rauf, Mbbs,Fcps

CONTACT

[email protected]

+923006023465

KEMU/ Mayo Hospital lahore

CONTACT

[email protected]

+924299214819

Sponsors and collaborators

Lead sponsor

King Edward Medical University

Other

Registry information

Official study title

Role of Topical Application of Lignocaine Versus 0.2% Glyceryl Trinitrate (GTN) Ointment as a Postoperative Local Analgesic in Hemorrhoidectomy in Terms of Pain Score,Wound Healing Time and Patient Satisfaction Level

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Sep 8, 2025
Registry last updated
Sep 8, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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