Saphenous Nerve Block Versus Femoral Nerve Block for Total Knee Arthroplasty
Saphenous (Adductor Canal) Nerve Block Versus Femoral Nerve Block for Total Knee Arthroplasty: A Novel Approach for Postoperative Analgesia
Currently, the regional anesthetic standard of care for total knee replacement surgery is combined spinal/epidural, with or without a femoral nerve block, or FNB. Lasting approximately 18 hours, the FNB works by numbing the femoral nerve (and its branches), which is the major nerve controlling the knee joint. The femoral nerve also provides movement and sensation. While this regional anesthetic technique offers significant postoperative pain relief, it is possible that it may cause muscle weakness and increase patients' recovery time. Hence there is a need for an alternative technique, one that may help minimize postoperative pain as effectively as the FNB, while not causing weakness of the quadriceps muscle.
The saphenous nerve, a branch of the femoral nerve, provides sensation to the knee. Thus it is hypothesized that by "blocking" or anesthetizing the saphenous nerve with local anesthetic closer to where it branches off, the area around and below the knee will feel numb. Yet unlike with the FNB, the quadriceps muscle itself will still be able to function.
Patients will be randomized to receive FNB or saphenous nerve block. Quadriceps strength will be tested using a dynamometer before surgery (baseline), 6-8 hours following anesthesia administration, and on postoperative days 1 and 2. It is hypothesized that patients who receive FNB will experience a 50% decrease in quadriceps strength compared to baseline.
研究概览
研究类型
注册 (实际的)
阶段
- 不适用
联系人和位置
学习地点
-
-
New York
-
New York、New York、美国、10021
- Hospital for Special Surgery
-
-
参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- All patients ages 18-90 undergoing primary unilateral total knee arthroplasty
- Planned use of neuraxial anesthesia
- Ability to follow study protocol
- American Society of Anesthesiology (ASA) Class 1-3
Exclusion Criteria:
- Contraindication to a spinal or epidural anesthetic
- Chronic opioid use (defined as daily or almost daily use of opioids for >3 months)
- Hypersensitivity and/or allergy to local anesthetics
- Intraoperative use of any volatile anesthetic
- Patients with a pre-existing neuropathy on the operative limb
- Contraindication to a femoral nerve block or saphenous nerve block
- Allergy to any of the study medications
- Non-English speaking patients
学习计划
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:双倍的
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
实验性的:Experimental
Saphenous (Adductor Canal) Nerve Block
|
The study group will receive the saphenous nerve block, at the level of the adductor canal.
The block will be under ultrasound guidance.
The local anesthetic will be 15 ml of 0.5% bupivicaine.
The study group will also receive a combined spinal epidural, with 2.5 ml of 0.5% bupivacaine as the spinal agent.
Additional drugs include anti-emetics, specifically Ondansetron (4 mg).
其他名称:
|
|
有源比较器:Control
Femoral Nerve Block
|
The control group will receive the femoral nerve block.
The block will be under ultrasound guidance.
The local anesthetic will be 30 ml of 0.25% bupivicaine.
The control group will also receive a combined spinal epidural, with 2.5 ml of 0.5% bupivacaine as the spinal agent.
Additional drugs include anti-emetics, specifically Ondansetron (4 mg).
其他名称:
|
研究衡量的是什么?
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Quadriceps Muscle Strength
大体时间:48 hours following administration of anesthesia.
|
Measurements were made by a handheld dynamometer while patients perform isometric exercises.
Results are presented in kilogram-force (kgF) units.
One kgF is equal to 9.80665 N.
|
48 hours following administration of anesthesia.
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Total Opioid Usage
大体时间:Postoperative day 4.
|
Opioid consumption data were collected and converted to oral morphine equivalents.
|
Postoperative day 4.
|
|
NRS Pain Scores at Rest
大体时间:Postoperative day 4.
|
Patients rated pain on a scale of 0-10, with 0 representing no pain and 10 representing worst pain.
|
Postoperative day 4.
|
|
Patient Satisfaction With the Nerve Block.
大体时间:24 hours following administration of anesthesia.
|
Patient satisfaction was measured on a 0-10 scale (0=not satisfied; 10=very satisfied).
|
24 hours following administration of anesthesia.
|
|
Incidence of Postoperative Complications.
大体时间:Postoperative day 4.
|
Postoperative day 4.
|
|
|
Total Length of Hospital Stay
大体时间:Total length of hospital stay
|
Total length of hospital stay
|
合作者和调查者
调查人员
- 首席研究员:David H. Kim, MD、Hospital for Special Surgery, New York
出版物和有用的链接
一般刊物
- Akkaya T, Ersan O, Ozkan D, Sahiner Y, Akin M, Gumus H, Ates Y. Saphenous nerve block is an effective regional technique for post-menisectomy pain. Knee Surg Sports Traumatol Arthrosc. 2008 Sep;16(9):855-8. doi: 10.1007/s00167-008-0572-4. Epub 2008 Jun 24.
- Capdevila X, Barthelet Y, Biboulet P, Ryckwaert Y, Rubenovitch J, d'Athis F. Effects of perioperative analgesic technique on the surgical outcome and duration of rehabilitation after major knee surgery. Anesthesiology. 1999 Jul;91(1):8-15. doi: 10.1097/00000542-199907000-00006.
- Bohannon RW. Measuring knee extensor muscle strength. Am J Phys Med Rehabil. 2001 Jan;80(1):13-8. doi: 10.1097/00002060-200101000-00004.
- Singelyn FJ, Deyaert M, Joris D, Pendeville E, Gouverneur JM. Effects of intravenous patient-controlled analgesia with morphine, continuous epidural analgesia, and continuous three-in-one block on postoperative pain and knee rehabilitation after unilateral total knee arthroplasty. Anesth Analg. 1998 Jul;87(1):88-92. doi: 10.1097/00000539-199807000-00019.
- Horn JL, Pitsch T, Salinas F, Benninger B. Anatomic basis to the ultrasound-guided approach for saphenous nerve blockade. Reg Anesth Pain Med. 2009 Sep-Oct;34(5):486-9. doi: 10.1097/AAP.0b013e3181ae11af.
- Kandasami M, Kinninmonth AW, Sarungi M, Baines J, Scott NB. Femoral nerve block for total knee replacement - a word of caution. Knee. 2009 Mar;16(2):98-100. doi: 10.1016/j.knee.2008.10.007. Epub 2008 Nov 28.
- Maffiuletti NA. Assessment of hip and knee muscle function in orthopaedic practice and research. J Bone Joint Surg Am. 2010 Jan;92(1):220-9. doi: 10.2106/JBJS.I.00305.
研究记录日期
研究主要日期
学习开始
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
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.