Analgesic Efficacy of Adductor Canal Block (ACB) Before and After Primary Total Knee Arthroplasty (TKA): A Prospective Randomized Trial to Compare Postoperative Clinical Outcomes
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Pain score associated with knee motion following TKA
研究概览
简要总结
Total knee arthroplasty (TKA) is associated with severe postoperative pain. Multimodal analgesia, including peripheral nerve block, is recommended for post-operative pain relief 1. Perineural analgesia offers the advantage of extended pain relief up to 24 hours after surgery2.
This is a prospective, randomized control trial designed to compare the analgesic efficacy of the adductor canal block (ACB) performed immediately before or immediately after primary total knee arthroplasty (TKA). The primary objective of this study is to measure pain score associated with knee motion following TKA among patients receiving ACB as part of their analgesic regimen for TKA. Secondary end points include assessment of postoperative ambulation, range of motion, pain at rest, opioid consumption, and patient satisfaction between the two analgesic approaches. The investigators hypothesize that ACB before the surgery will reduce a patient's postoperative pain and improve patient satisfaction.
All consecutive patients undergoing primary TKA will be recruited for enrollment in the study. Patients will be for randomized preoperatively to receive either preemptive ABC (PreACB) or postoperative ABC (PostACB). Patients randomized to the PreACB group will receive the block prior to incision. Patients randomized to the PostACB group will receive the block at the end of the surgery. Both techniques are in accordance to the standard of care at our institute. All patients will have the ACB done by a regional anesthesiologist in the regional anesthesia unit, or in the operating room. Patient medical history will be obtained and blocks will be placed per usual protocol. Operative and anesthetic details, including medications given, will be recorded.
Pain scores and pain medications given in the PACU will be recorded. Supplementary analgesics will be provided per institutional PACU protocol. Study data will be recorded for up to 72 hours or until patient discharge. A follow-up will occur in 4- 6 weeks at the orthopedic follow-up appointment to evaluate the patient's late pain scores and overall satisfaction. Data will be analyzed both at the conclusion of the study and at several intervals prior to completion of the study.
详细描述
D. Research Design and Methods
Inclusion Criteria:
The study is a prospective, randomized controlled clinical trial comparing two methods of regional analgesia for primary TKA. All adult primary TKA patients are eligible for inclusion in the study.
Exclusion criteria:
- Allergy to local anesthetics or to systemic opioids
- Contraindication to regional anesthesia technique, such as local infection or coagulopathy
- Sensory/motor disorder involving operative limb
- Requirements of more than 30 mg morphine equivalent daily prior to surgery
- ASA 4 or greater
- Psychiatric or cognitive disorders
- Incarceration
- Renal insufficiency with Cr > 2.0
- Hepatic failure
- Pregnancy
- Age under 18 years Potential risks for the procedure, which will be explained to the patient, include: bleeding, local infection, local anesthetic toxicity. All are commonly listed as rare complications of the procedures.
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
- None
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
- •The study is a prospective, randomized controlled clinical trial comparing two methods of regional analgesia for primary TKA. All adult primary TKA patients are eligible for inclusion in the study.
排除标准
- •Allergy to local anesthetics or to systemic opioids
- •Contraindication to regional anesthesia technique, such as local infection or coagulopathy
- •Sensory/motor disorder involving operative limb
- •Requirements of more than 30 mg morphine equivalent daily prior to surgery
- •ASA 4 or greater
- •Psychiatric or cognitive disorders
- •Incarceration
- •Renal insufficiency with Cr > 2.0
- •Hepatic failure
- •Pregnancy
- •Age under 18 years
研究组 & 干预措施
Patients receiving ACB before primary TKA
Patients receiving adductor canal block (ACB) before primary total knee arthroplasty (TKA).
Patients randomized to this group will receive the block prior to incision after induction of general anesthesia
干预措施: 0.5% ropivacaine (Drug)
Patients receiving ACB after primary TKA
Patients receiving adductor canal block (ACB) immediately after primary total knee arthroplasty (TKA).
Patients randomized to this group will receive the block at the end of the surgery.
干预措施: 0.5% ropivacaine (Drug)
结局指标
主要结局
Pain score associated with knee motion following TKA
时间窗: 4-6 Weeks postoperatively
This study's primary endpoint the change in the patient's reported pain score on the preoperative visit, on postoperative day (POD) 1, and the patient's pain score reported on the 4-6 week follow- up visit. Pain score will be measured using a numeric verbal analogue scale (1-10). Pain will be measured using this scale on the pre-operative visit, and on POD1 prior to manipulation, with active (patient driven) movement and with passive (physician elicited) movement.
次要结局
- Blood transfusion(Up to 24 weeks)
- Patient satisfaction with the two analgesic approaches 4-6 weeks postopertively(4-6 weeks postoperatively)
- Abnormal hemoglobin concentration values(Up to 24 weeks)
- Duration of hospital stay(Up to 24 weeks)
- Opioid consumption(4-6 weeks postoperatively)
- Patient satisfaction between the two analgesic approaches.(24 hours postoperatively)
- Non opioid analgesia consumption(4-6 weeks postoperatively)
- Assessment of postoperative ambulation.(4-6 weeks postoperatively)
- Assessment of postoperative pain at rest(4-6 weeks postoperatively)
- Thrombo-embolic complications(Up to 24 weeks)