Analgesic Efficacy of IPACK Versus Selective Tibial Nerve Block in Patients Scheduled for Anterior Cruciate Ligament Reconstruction Under General Anaesthesia With an Adductor Canal Block: a Randomized Controlled Double-blinded Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 80
- 试验地点
- 2
- 主要终点
- Total intravenous morphine consumption
研究概览
简要总结
The purpose of this study is to compare the analgesic efficacy of the combination of an adductor canal and selective tibial nerve blocks versus adductor canal block and IPACK after ACL reconstruction under general anaesthesia.
详细描述
The hypothesis of this study is that a combined adductor canal and selective tibial nerve block provides better analgesia than a combined adductor canal block and IPACK in patients undergoing anterior cruciate ligament reconstruction.
This randomized controlled trial will include two groups: an adductor canal block plus IPACK group (group IPACK) and an adductor canal block plus tibial selective nerve block group (group TIBIAL). After written informed consent, patients will be allocated to one of the groups, following a computer-generated list of randomization.
Prior to surgery, all patients will have an adductor canal block with 20ml of ropivacaine 0.75%. In group TIBIAL the patient will receive in addition a selective tibial nerve block with 5 ml of ropivacaine 0.75%. In group IPACK the patient will receive in addition an IPACK with 20ml of ropivacaine 0.2%. In both groups, patients will have the surgery under general anaesthesia with a multimodal analgesic regimen inclusive of iv dexamethasone 8 mg, iv magnesium sulfate 40 mg.kg-1, iv ketorolac 30 mg, and iv acetaminophen 1000 mg.
After surgery, all patients will be prescribed an iv patient-controlled analgesia (PCA) of morphine (boluses of 2 mg available every 10 min, maximum of 40 mg every 4 hours) along with oral acetaminophen (1000 mg every 6 h) and oral ibuprofen (400 mg every 8 hours). Oral ondansetron 4 mg every 8 hours will be available on request in case of nausea or vomiting.
The primary outcome will be the cumulative iv morphine consumption at 24 h postoperatively. Secondary outcomes will include pain- and functional-related outcomes. Pain-related outcomes include cumulative morphine consumption at 2h and 48h postoperatively, rest and dynamic pain scores and rate of PONV at 2 h, 24 h and 48 h postoperatively. Early functional-related outcomes include range of motion, strength and walking distance at 24 h and 48 h postoperatively. Late functional-related outcomes include range of motion, strength, hop distance, agility test, Y balance test, Anterior Cruciate Ligament Return to Sport After Injury Scale (ACL-RSI) and International Knee Documentation Committee Scale (IKDC) at 4 and 8 months postoperatively.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •ASA score I-III
- •18 years or older
- •Scheduled for elective primary ACL reconstruction
- •Signature of consent form
排除标准
- •Refusal or inability for informed consent
- •Known allergies to ropivacaine, acetaminophen, ibuprofen, ketorolac, morphine, sufentanyl, ondansetron or dexamethason
- •Secondary surgical revision
- •Opioid treatment such as morphine, hydrocodone, hydromorphone, tramadol, methadone, fentanyl, buprenorphine or codeine
- •Bleeding diathesis
- •Neurological deficit
- •Known renal insufficiency (eGFR <45 ml/min)
- •Known hepatic insufficiency (Child score B or C)
- •Pregnancy or lactating
- •Alcohol abuse
结局指标
主要结局
Total intravenous morphine consumption
时间窗: 1 day postoperatively
Consumption in mg
次要结局
- Total intravenous morphine consumption(2 hours and 2 days postoperatively)
- Resting and dynamic pain score(2 hours, 1 day and 2 days postoperatively)
- Incidence of postoperative nausea and vomiting(2 hours, 1 day and 2 days postoperatively)
- Range of motion(4 months and 8 months postoperatively)
- Walking distance(1 day and 2 days postoperatively)
- Single hop distance, triple hop distance and crossover triple hop distance(4 months and 8 months postoperatively)
- Y balance test(4 months and 8 months postoperatively)
- Quadriceps strength(1 day and 2 days postoperatively)
- Concentric quadriceps strength and concentric hamstring strength(4 months and 8 months postoperatively)
- International Knee Documentation Committee Scale score(4 months and 8 months postoperatively)
- Agility test(4 months and 8 months postoperatively)
- Anterior Cruciate Ligament Return to Sport After Injury Scale score(4 months and 8 months postoperatively)
研究者
Eric Albrecht
Prof. Dr. med. Eric Albrecht
Centre Hospitalier Universitaire Vaudois