None listed
Conditions
Brief summary
Title: Role of Ropivacaine Infiltration in Postoperative Analgesia for Perianal Procedures: A Randomized Controlled Trial Objective: To determine whether infiltration of ropivacaine at the surgical site reduces postoperative pain and analgesic consumption in patients undergoing perianal procedures (hemorrhoidectomy, fistulectomy, lateral Internal Sphincterotomy). Design: Double-blinded, placebo-controlled randomized controlled trial. Setting: Department of General Surgery, Fatima Memorial Hospital, Lahore. Sample Size: 100 patients (50 per group). Intervention: Group A (Intervention): 20 ml of 0.25% ropivacaine infiltration at surgical site Group B (Control): 20 ml of normal saline (placebo) infiltration Primary Outcome: Postoperative pain score measured by Visual Analog Scale (VAS) at 6, 12, and 24 hours. Secondary Outcomes: Total analgesic consumption in first 24 hours Time to first rescue analgesia Conclusion Expected: If proven effective, ropivacaine infiltration may reduce postoperative pain, decrease need for systemic analgesics, improve patient comfort, and help establish standardized pain management protocols for perianal surgery in local practice. Null Hypothesis: No significant difference in pain scores or analgesic requirements between the two groups.
Interventions
International Non-proprietary Name (INN):
Ropivacaine
Dose:
20 mL of 0.25% ropivacaine infiltration administered once at the end of surgery
Duration of Treatment:
Single intraoperative administration with postoperative assessment over 24 hours
Mode of Delivery:
Local surgical site infiltration (perianal wound infiltration)
Adherence:
Intervention administered intraoperatively by a designated surgical resident according to randomized allocation; adherence ensured through direct administration
International Non-proprietary Name (INN): Ropivacaine Dose: 20 mL of 0.25% ropivacaine infiltration administered once at the end of surgery Duration of Treatment: Single intraoperative administration with postoperative assessment over 24 hours Mode of Delivery: Local surgical site infiltration (perianal wound infiltration) Adherence: Intervention administered intraoperatively by a designated surgical resident according to randomized allocation; adherence ensured through direct administration and allocation record monitoring
Sponsors
Fatima Memorial Hospital Lahore
Study design
Allocation
Randomised controlled trial
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
20 Years to 60 Years
Healthy volunteers
No
Inclusion criteria
• Patients aged 20–60 years • Either gender • Patients undergoing elective perianal procedures •American Society of Anesthesiologists (ASA) physical status I or II
Exclusion criteria
• Known allergy to local anesthetics • Chronic opioid or analgesic use • Previous perianal surgery • Coagulopathy • Local infection at the site of infiltration
Outcome results
None listed