A Phase 4 interventional study of 5 ml of 0.5% bupivacaine infiltrated at each port site and Placebo in Arthroscopic Surgery, sponsored by Khyber Teaching Hospital. Recruiting at 1 site in Pakistan. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2026-06-25.
Sponsored by Khyber Teaching Hospital · Phase 4, Interventional, and Prevention
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.
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.
5,640 studies on the registry are indexed under Pain, Postoperative; 1,230 are open to participants now.
This study's planned enrollment of 60 is below the median of 75 across 4,821 interventional studies indexed under Pain, Postoperative.
Browse Pain, Postoperative studies →Khyber Teaching Hospital is the lead sponsor of 29 studies on the registry; 19 are open to participants now.
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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 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
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
group A (intervention group) will receive 5 ml of 0.5% bupivacaine infiltrated at each port site
Drug: 5 ml of 0.5% bupivacaine infiltrated at each port site
Group B (intervention group) will receive 5 ml of 0.9% Normal Saline infiltrated at each port site
Drug: Placebo
5 ml of 0.5% bupivacaine infiltrated at each port site after the arthroscopic procedures
5ml 0.9%normal saline infiltrated at port site
Postoperative Port Site Pain Score
Pain will be measured using the Visual Analog Scale (VAS) ranging from 0 (no pain) to 10 (worst pain), at the port site following knee arthroscopy.
Time frame: 6 hours, 12 hours, and 24 hours postoperatively
Proportion of Patients Achieving Early Mobility
Early mobility is defined as the ability to perform prescribed physical therapy exercises and ambulate (with assistance from a caregiver or ambulatory aids) within 6 hours after knee arthroscopic surgery. This will be recorded as a binary outcome (Yes/No) based on physiotherapist evaluation
Time frame: Assessed after 6 hours of completion of procedure
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Khyber Teaching Hospital