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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
64
Applied to the anal wound three time daily after hemorrhoidectomy.
Applied to the anal wound three time daily after hemorrhoidectomy.
King Edward Medical uUniveristy Mayo Hospital
Lahore, Punjab Province, Pakistan
RECRUITINGPostoperative 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
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