King Edward Medical uUniveristy Mayo Hospital
Lahore, Punjab Province, 54000, Pakistan
Location status: Recruiting
Location contact
Hafiz Ahmad Rauf, Mbbs
CONTACT
Hafiz Ahmad Rauf, Mbbs
PRINCIPAL_INVESTIGATOR
NCT Number: NCT07159334
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.
Interested in participating?
Request Info18 year–60 year
All sexes
Interventional
Not applicable
Lahore, Punjab Province, 54000, Pakistan
Location status: Recruiting
Hafiz Ahmad Rauf, Mbbs
CONTACT
Hafiz Ahmad Rauf, Mbbs
PRINCIPAL_INVESTIGATOR
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Applied to the anal wound three time daily after hemorrhoidectomy.
Applied to the anal wound three time daily after hemorrhoidectomy.
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.
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.
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.
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.
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.
Time frame: 1 month postoperatively
Presence of wound secretion (yes/no) as noted on clinical examination.
Time frame: 1 month postoperatively
Patient-reported pruritus at wound site (yes/no)
Time frame: 1 month postoperatively
Occurrence of wound bleeding postoperatively (yes/no).
Time frame: 1 month postoperatively
Patient-reported headache severity measured using a Numerical Rating Scale (0 = no headache, 10 = worst imaginable).
Contact information is provided by the study sponsor or research team.
Hafiz Ahmad Rauf, Mbbs,Fcps
CONTACT
KEMU/ Mayo Hospital lahore
CONTACT
King Edward Medical University
Other
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
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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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