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临床试验/NCT07090928
NCT07090928招募中4 期

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

Khyber Teaching Hospital1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2026年3月10日最近更新:
干预措施
相关药物

试验速览

阶段
4 期
状态
招募中
入组人数
60
试验地点
1
主要终点
Postoperative Port Site Pain Score

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
None

入排标准

年龄范围
18 Years 至 70 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Either Male or Female Age range: 18-70 Years Patients scheduled to undergo elective knee arthroscopic procedures Able to understand the VAS pain scale

排除标准

  • 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

研究组 & 干预措施

Intervention group

Experimental

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

干预措施: 5 ml of 0.5% bupivacaine infiltrated at each port site (Drug)

Control group

Placebo Comparator

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

干预措施: Placebo (Drug)

结局指标

主要结局

Postoperative Port Site Pain Score

时间窗: 6 hours, 12 hours, and 24 hours postoperatively

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.

次要结局

  • Proportion of Patients Achieving Early Mobility(Assessed after 6 hours of completion of procedure)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Zeeshan Arif

Trainee Medical Officer

Khyber Teaching Hospital

研究点 (1)

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