NCT03864588Unknown4 期
A Randomized Controlled Trial Comparing Intraoperative Surgeon-Performed Versus Anesthesiologist-Performed Adductor Canal Blockade After Primary Total Knee Arthroplasty
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 入组人数
- 164
- 试验地点
- 1
- 主要终点
- Change in visual analog scale pain score
研究概览
简要总结
The purpose of this study is to evaluate the efficacy of two methods of administering an adductor canal block (ACB) following total knee arthroplasty (TKA); intraoperative surgeon performed intra-articular adductor canal block (IACB) and anesthesiologist ultrasound guided ADC in the post-anesthesia recovery unit (PACU).
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients undergoing unilateral primary TKA with underlying diagnosis of osteoarthritis
- •ASA I - III
- •Spinal anesthesia
- •All patients will have cemented total knee utilizing a medial parapatellar approach with posterior stabilized or cruciate retaining implants. A tourniquet will be used in all cases.
- •Patients must be between 18 and 80 years of age.
- •Active and valid email address for the participant.
排除标准
- •Allergy to anesthetics or study analgesic medications.
- •Contraindication to regional anesthesia
- •Non-english speaking
- •ASA IV or greater
- •Renal insufficiency with Cr > 2.0 or hepatic failure
- •General or epidural anesthesia
- •Sensory/motor disorder involving the operative limb
- •Patients who consume preoperative opioids for pain control.
- •Pregnant women
- •Mentally disabled patients and patients with psychiatric disorders that would prevent them from properly understanding and evaluating an informed consent process.
- •Prisoners
研究组 & 干预措施
Control
Placebo Comparator
Anesthesiologist preforms ultrasound guided adductor canal block post-operatively
干预措施: Ropivacaine (Drug)
Intervention
Experimental
Surgeon preforms inter-operative adductor canal block
干预措施: Ropivacaine (Drug)
结局指标
主要结局
Change in visual analog scale pain score
时间窗: Up to 6 weeks post-surgery
The primary end point is the patients' reported visual analogue pain score (VAS). 0-100mm scale
次要结局
- Change in daily opioid consumption(up to 6 weeks post-surgery)
- Change in range of motion(up to 6 weeks post-surgery)
- Change in timed up and go(up to 6 weeks post-surgery)
研究者
研究点 (1)
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