Comparing Postoperative Functional Recovery and Analgesic Efficacy of a Single Shot Sciatic Nerve Block Versus Posterior Capsule/Fat Pad Infiltration of Local Anesthetic for Total Knee Arthroplasty
2014年11月19日 更新者：Dr. Ben Safa、Sunnybrook Health Sciences Centre
A Prospective, Unicenter, Randomized, Placebo Controlled, Clinical Interventional Trial, Comparing the Postoperative Functional Recovery as Well as Analgesic Efficacy of a Single Shot Sciatic Nerve Block Versus Posterior Capsule/Fat Pad Infiltration of Local Anesthetic for Total Knee Arthroplasty.
Many methods of pain relief have been implemented in an attempt to provide safe and effective analgesia for patients following total knee arthroplasty.
Numerous studies have demonstrated that nerve blocks can provide superior pain control and reduce side effects.
There are two major nerves that provide sensation to the knee: the femoral nerve provides sensation to the front of the knee and sciatic nerve provides sensation to the back of the knee.
Putting local anesthetic close to these nerves provides superior pain control.
The literature has supported the use of femoral nerve block for analgesia as well as improved functional outcome after total knee arthroplasty.
The purpose of this study is to see if the same is true for sciatic nerve block for the back of the knee.
We also would like to study an alternative approach to make the back of the knee pain free.
This involves injecting local anesthetic directly into this area at the end of your surgery.Patients will be randomized into 3 groups: sciatic block, posterior infiltration of local anesthetic and placebo.This study will help further define the role of sciatic nerve block as well as the alternative technique of local anesthetic infiltration in the perioperative analgesic regimen of total knee arthroplasty surgery, in an effort to develop a standardized perioperative protocol for this patient population.
The advent of this protocol should allow reduced risk, improved analgesia, and potentially earlier discharged from hospital with better function.
研究概览
地位
完全的
详细说明
The objectives of this study are:
- Evaluate the role of sciatic nerve block in total knee replacement. There is conflicting data as to whether sciatic nerve block would provide significant analgesic benefit in addition to femoral nerve block and the usual multimodal and preemptive analgesic regimen for TKA.
- Investigate the efficacy of single-shot sciatic nerve block on early rehabilitation, functional recovery and patient satisfaction.
- Evaluate the previously described technique of local anesthetic infiltration into the posterior capsule/fat pad of the knee as an alternative technique to sciatic nerve block in providing analgesia to the posterior aspect of the knee in this select group of patients.
- Investigate the efficacy of local anesthetic infiltration into the posterior capsule/fat pad of the knee on early rehabilitation, functional recovery and patient satisfaction.
Study Design:
All patients will have a femoral nerve block (FNB) and spinal anesthesia.
Patients will be randomized into one of the 3 possible groups:
Group 1: Femoral nerve block + Sciatic nerve block + Spinal anesthesia + Infiltration of normal saline at the end of surgery
Group 2: Femoral nerve block + Sham Sciatic nerve block + Spinal anesthesia + Infiltration of local anesthetic at the end of surgery.
Group 3: Femoral nerve block + Sham Sciatic nerve block + Spinal anesthesia. + Infiltration of normal saline at the end of surgery.
In summary, this study will help further define the role of sciatic nerve block as well as the alternative technique of local anesthetic infiltration in the perioperative analgesic regimen of total knee arthroplasty surgery, in an effort to develop a standardized perioperative protocol for this patient population. The advent of this protocol should allow reduced risk, improved analgesia, and potentially earlier discharged from hospital with better function.
研究类型
介入性
注册 (实际的)
104
阶段
- 不适用
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习地点
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Ontario
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Toronto、Ontario、加拿大、M2N-3Y7
- Holland Orthopedic and Arthritic Centre
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参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
18年 至 75年 (成人、年长者)
接受健康志愿者
不
有资格学习的性别
全部
描述
Inclusion Criteria:
- American Society of Anesthesiologists physical status I and III
- Scheduled for total knee arthroplasty
Exclusion Criteria:
- Patients not providing informed consent.
- Refusal of treatment plan.
- Preexisting medical/neurological/hematologic conditions contraindicated for spinal anesthesia or peripheral nerve blocks.
- Revision total knee arthroplasty.
- Known allergy to any of the medications being used.
- History of drug or alcohol abuse.
- Patients with chronic pain on slow-release preparations of opioid in excess of 30mg of morphine equivalence per day.
- Patients with Rheumatoid Arthritis.
- Patients with psychiatric disorders.
- Patients unable or unwilling to use Patient Controlled Analgesia.
- Diabetic patients or those with impaired renal function (Creatinine >106).
- Obese patients (i.e. BMI >45).
- Postoperatively, patients will be excluded if they have had additional operative procedures requiring a change in the usual rehabilitation protocol of care.
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：三倍
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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实验性的：1个
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Patients randomized to Group 1 will receive a single sciatic nerve block using the infragluteal parabiceps approach, using 20 ml of 0.5 % Ropivacaine.
A sham injection of the posterior capsule and fat pad using 50 cc of normal saline will be conducted at the conclusion of the surgery.
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实验性的：2个
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Patients randomized to Group 2 will receive a Sham sciatic nerve block using 20cc of normal saline as described above as well as extensive local anesthetic infiltration of the posterior capsule and fat pad with a solution of 50 ml of 0.2% ropivicaine.
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假比较器：3个
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Patients randomized to group 3 will only receive a continuous femoral nerve catheter, A sham sciatic nerve block with 20cc of normal saline as well as a sham injection of the posterior capsule and fat pad will be performed with 50cc of normal saline.
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研究衡量的是什么？
主要结果指标
结果测量 |
大体时间 |
|---|---|
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Visual Analog Scale (VAS) for pain will be used (0=no pain, 100mm = terrible pain) as our primary outcome, for 72 hours post-operatively (at rest and during mobilization).
大体时间：On arrival to PACU and every 4 hours thereafter.
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On arrival to PACU and every 4 hours thereafter.
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次要结果测量
结果测量 |
大体时间 |
|---|---|
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The TUG (Timed up and go test) and Range of motion.
大体时间：Performed on day 2 and 3.
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Performed on day 2 and 3.
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合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
调查人员
- 首席研究员：Ben Safa, MD, FRCPC、Staff Anesthesiologist, Sunnybrook Health Sciences Centre.
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始
2008年6月1日
初级完成 (实际的)
2012年9月1日
研究完成 (实际的)
2012年11月1日
研究注册日期
首次提交
2008年5月12日
首先提交符合 QC 标准的
2008年5月13日
首次发布 (估计)
2008年5月14日
研究记录更新
最后更新发布 (估计)
2014年11月21日
上次提交的符合 QC 标准的更新
2014年11月19日
最后验证
2011年7月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.
全膝关节置换术的临床试验
Sciatic Nerve Block的临床试验
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Queen Mary University of LondonNational Health Service, United Kingdom未知
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University of PennsylvaniaUniversity of Wisconsin, Madison; Philips Healthcare; National Aeronautics and Space Administration...完全的