Effectiveness of Per-Operative Bupivicaine in Reducing Postoperative Pain at Port Site and Improving Mobility in Knee Arthoscopic Procedures

NCT ID: NCT07090928

Last Updated: 2025-07-29

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: PHASE4
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-08-01
• Study Completion Date: 2026-03-31

Brief Summary

The investigator's aim is to evaluate the effectiveness of per-operative bupivacaine infiltration at arthroscopic port sites in reducing post-operative pain compared to placebo in patients undergoing knee arthroscopic procedures.

Detailed Description

Knee arthroscopy is a minimally invasive surgical procedure widely used to diagnose and treat various knee conditions such as trauma leading to meniscal tears or ligament, patellar dislocations and post-knee arthroplasty complications. Despite its less invasive nature compared to open surgery, patients often experience postoperative pain, particularly at port sites where surgical instruments are introduced which can impair early mobilization and delay recovery, and affect patient satisfaction with the procedure.

Pain management after knee arthroscopy remains a challenge in orthopaedic practice. While various analgesic strategies have been employed, including oral analgesics such as NSAIDs or opioid, intravenous analgesics or intra-articular injections. Yet, the optimal approach in managing port site pain specifically has not been fully established. Port site pain can be troublesome as it may restrict movement and contribute to delayed functional recovery after arthroscopic procedures.

Bupivacaine, a long-acting amide local anesthetic, has been used as postoperative analgesia for many procedures. Its infiltration around surgical incisions has shown promise in reducing pain after different types of surgeries. In knee arthroscopy, bupivacaine has been used intra-articularly with varying reports of its efficacy, but less attention has been given to its specific use for port site pain control and its subsequent impact on early mobility.

Recent studies have demonstrated the potential outcomes of infiltration of local anesthesia at port sites in laparoscopic procedures, suggesting similar techniques could give successful results in arthroscopic knee surgery. The effectiveness of peri-articular infiltration has been documented in total knee arthroplasty, but evidence specifically addressing arthroscopic port sites remains limited. However, a randomized controlled trial, intra-articular levo-bupivacaine demonstrated significantly lower postoperative visual analogue scale (VAS) pain scores of mean 3.2 ± 1.1 compared to bupivacaine mean VAS pain score 4.5 ± 1.3, indicating superior analgesic effect following knee arthroscopy.

This study aims to evaluate the effectiveness of per-operative bupivacaine infiltration at arthroscopic port sites in reducing postoperative pain and improving early mobility following knee arthroscopic procedures. By precisely targeting port site pain, the investigator can postulate that patients will experience greater comfort, require fewer analgesics, and achieve earlier recovery. The findings could provide valuable evidence to establish protocols for port site pain management in knee arthroscopy, potentially improving patient outcomes.

Conditions

Arthroscopic Surgery

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Intervention group

group A (intervention group) will receive 5 ml of 0.5% bupivacaine infiltrated at each port site

Group Type: EXPERIMENTAL

5 ml of 0.5% bupivacaine infiltrated at each port site

Intervention Type: DRUG

5 ml of 0.5% bupivacaine infiltrated at each port site after the arthroscopic procedures

Control group

Group B (intervention group) will receive 5 ml of 0.9% Normal Saline infiltrated at each port site

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

5ml 0.9%normal saline infiltrated at port site

Interventions

5 ml of 0.5% bupivacaine infiltrated at each port site

5 ml of 0.5% bupivacaine infiltrated at each port site after the arthroscopic procedures

Intervention Type: DRUG

Placebo

5ml 0.9%normal saline infiltrated at port site

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

Inclusion Criteria Either Male or Female Age range: 18-70 Years Patients scheduled to undergo elective knee arthroscopic procedures Able to understand the VAS pain scale Exclusion Criteria Either Male or Female Age range: 18-70 Years Patients scheduled to undergo elective knee arthroscopic procedures Able to understand the VAS pain scale Known hypersensitivity or allergy to bupivacaine or any local anesthetics Chronic pain conditions requiring regular pain medications History of drug abuse (mainly to opioids) Pregnant women Pre-existing impaired knee mobility No willing to participate in trial

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Khyber Teaching Hospital

OTHER

Sponsor Role: lead

Responsible Party

Zeeshan Arif

Trainee Medical Officer

Responsibility Role: PRINCIPAL_INVESTIGATOR

Other Identifiers

476/DME/KMC

Identifier Type: -

Identifier Source: org_study_id