An interventional study of Lignocaine Ointment and Glyceryl Trinitrate Ointment 0.2% in Hemorrhoid and Postoperative Pain, sponsored by King Edward Medical University. Recruiting at 1 site in Pakistan. Open to participants aged 18 Years to 60 Years. Per ClinicalTrials.gov, last updated 2025-09-08.
Sponsored by King Edward Medical University · Not applicable, Interventional, and Treatment
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.
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.
238 studies on the registry are indexed under Hemorrhoids; 73 are open to participants now.
This study's planned enrollment of 64 is below the median of 100 across 183 interventional studies indexed under Hemorrhoids.
Browse Hemorrhoids studies →King Edward Medical University is the lead sponsor of 82 studies on the registry; 27 are open to participants now.
Counted across the registry records on this site, refreshed daily.
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Exclusion Criteria:
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%
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%
Applied to the anal wound three time daily after hemorrhoidectomy.
Applied to the anal wound three time daily after hemorrhoidectomy.
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.
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.
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
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
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
Incidence of Wound Secretion
Presence of wound secretion (yes/no) as noted on clinical examination.
Time frame: 1 month postoperatively
Incidence of Itching
Patient-reported pruritus at wound site (yes/no)
Time frame: 1 month postoperatively
Incidence of Postoperative Bleeding
Occurrence of wound bleeding postoperatively (yes/no).
Time frame: 1 month postoperatively
Incidence and Severity of Headache
Patient-reported headache severity measured using a Numerical Rating Scale (0 = no headache, 10 = worst imaginable).
Time frame: 1 month postoperatively
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: Undecided
Started Aug 2025 (actual). Primary completion is estimated for Dec 2025, 4 months after the start.
Of 65 non-industry interventional studies with no phase under Hemorrhoids, half reached primary completion within 23 months of starting (the median), counting those still running; a quarter within 12 and three quarters within 35. This study's planned 4 months is below that.
Counting every sponsor, half of 70 studies reached it within 23 months; a quarter within 10 and three quarters within 35.
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Studies of the drugs tested here: Lidocaine · Nitroglycerin
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