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IRCT20260528069554N1 IRCT 2026-06-03 Fatima Memorial Hospital Lahore Can Ropivacaine Help Reduce Pain After Perianal Procedures? Role of Ropivacaine Infiltration in Postoperative Analgesia for Perianal Procedures: A Randomized Controlled Trial 2026-10-01 anticipated 100 Pending https://irct.ir/trial/90443 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Eligible participants will be randomly assigned in a 1:1 ratio to either the intervention group or the control group using permuted block randomization with a fixed block size of eight. A computer-generated randomization sequence will be prepared by an investigator who is not involved in patient recruitment or outcome assessment. The allocation sequence will be placed in sequentially numbered, opaque, sealed envelopes. After obtaining informed consent and confirming eligibility, the recruiting investigator will open the next envelope in numerical order to determine the participant's group assignment. This process will ensure both random allocation and allocation concealment until the time of assignment, Blinding description: There is double blinding. Both the participants and the investigator involved will be blinded to treatment allocation. Participants randomized to the intervention group will receive ropivacaine injection, while those in the control group will receive 20 mL of normal saline placebo. The solutions will be prepared in identical syringes containing equal volumes, making them indistinguishable in appearance. An independent individual not involved in participant enrollment, intervention administration, outcome assessment, or data analysis will prepare the solutions. 4 Condition 1: Peri-Anal Surgical Conditions-( Fistula in ANO + Chronic Anal Fissure). Condition 2: Peri-Anal Surgical Conditions( Haemorrhoids). Intervention 1: Intervention group: 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 24hr Mode of Delivery: Local surgical site infiltration (perianal wound infiltration). Intervention 2: Control group: International Non-proprietary Name (INN):Normal Saline Dose: 20 mL of 0.9% Normal Saline infiltration administered once at the end of surgery Duration of Treatment: Single intraoperative administration with postoperative assessment over 24hr Mode of Delivery: Local surgical site infiltration (perianal wound infiltration). Yes - There is a plan to make this available What will be shared: De-identified individual participant data: • Published results • Primary outcome When: From: After publication of main results To: No end date To whom: 1)Anyone 2)Researchers Conditions: 1)Systematic reviews and meta-analyses 2)Health economic analyses 3)Studies testing whether findings can be repeated or confirmed 4)Teaching research methods or developing new statistical techniques Where to obtain: Email of trial custodian, sponsor or committee: rana.jee789@gmail.com How to obtain: Requires approval by an ethics committee Requires a data sharing agreement between data requester and trial custodian or sponsor Comments:
public Abdullah Ayub
Agro Flats Shadman-1 Lahore.
Lahore Pakistan 54000 +92 316 7135772 rana.jee789@gmail.com Fatima Memorial Hospital Lahore scientific Abdullah Ayub
Agro flats, Shadman-1 Lahore
Lahore Pakistan 54000 +92 316 7135772 rana.jee789@gmail.com Fatima Memorial Hospital Lahore Pakistan • Patients aged 20–60 years • Either gender • Patients undergoing elective perianal procedures • ASA physical status I or II 20 years 60 years Both Known allergy to local anesthetics Chronic opioid or analgesic use Previous perianal surgery Coagulopathy Local infection at the site of infiltration K60 K64.2 Fissure and fistula of anal and rectal regions Third degree hemorrhoids Treatment - Drugs Placebo Intervention group: 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 24hr Mode of Delivery: Local surgical site infiltration (perianal wound infiltration) Control group: International Non-proprietary Name (INN):Normal Saline Dose: 20 mL of 0.9% Normal Saline infiltration administered once at the end of surgery Duration of Treatment: Single intraoperative administration with postoperative assessment over 24hr Mode of Delivery: Local surgical site infiltration (perianal wound infiltration) Post-operative Pain. Timepoint: It will be assessed at 6, 12 and 24 hours post-operatively. Method of measurement: Visual Analog Score for Pain 0-3 Mild 4-7 Moderate 8-10 Severe. Requirement of Post-operative analgesic requirements. Timepoint: 24hours post-operatively. Method of measurement: Milligrams of analgesics used in both the groups. Time to first rescue analgesia. Timepoint: 24 hours post-operatively. Method of measurement: Hours post-operatively when analgesia was asked. Fatima Memorial Hospital Lahore Approved 2026-05-04 Institutional Review Board Shadman-1 Lahore Lahore Punjab Pakistan