Role of Ropivacaine Infiltration in Postoperative Analgesia for Perianal Procedures: A Randomized Controlled Trial

To determine whether infiltration of ropivacaine at the surgical site reduces postoperative pain and analgesic consumption in patients undergoing perianal procedures.

Two-arm parallel-group randomized placebo-controlled trial comparing perianal wound infiltration with 20 mL of 0.25% ropivacaine versus 20 mL of 0.9% normal saline at the end of surgery. Participants will be allocated in a 1:1 ratio. The study includes blinded postoperative care and blinded outcome assessment, with postoperative follow-up for 24 hours.

This trial will be conducted in Fatima Memorial Hospital Lahore,Pakistan. Patients will be recruited from the surgical OPD coming for elective Peri-Anal procedures. Study is double blinded, Particpant and the data analyser/Investigator will be blinded.

Inlcsuion: • Patients aged 20–60 years • Either gender • Patients undergoing elective perianal procedures • ASA physical status I or II Exclusion: • Known allergy to local anesthetics • Chronic opioid or analgesic use • Previous perianal surgery • Coagulopathy • Local infection at the site of infiltration

Interventional Group 20 mL of 0.25% ropivacaine infiltration administered once at the end of surgery Single intraoperative administration with postoperative assessment over 24 hours Local surgical site infiltration (perianal wound infiltration) Control Group(Placebo) 20 mL of 0.9% Normal Saline infiltration administered once at the end of surgery Single intraoperative administration with postoperative assessment over 24 hours Local surgical site infiltration (perianal wound infiltration)

1)Post-operative Pain. Visual Analog Score for Pain 0-3 Mild 4-7 Moderate 8-10 Severe 2)Requirement of Post-operative analgesic requirements. 3)Time to first rescue analgesia

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.

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.

De-identified individual participant data: • Published results • Primary outcome

From: After publication of main results To: No end date

1)Anyone 2)Researchers

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

Email of trial custodian, sponsor or committee: rana.jee789@gmail.com

Requires approval by an ethics committee Requires a data sharing agreement between data requester and trial custodian or sponsor