Overview
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.
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.
Eligibility
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