跳至主要内容
临床试验/NCT01313546
NCT01313546Unknown早期 1 期

A Comparison of Sartorius Vs. Quadriceps Evoked Motor Response for Femoral Nerve to Prevent Secondary Catheter Failure

Sunnybrook Health Sciences Centre1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2011年5月最近更新:
适应症

试验速览

阶段
早期 1 期
入组人数
40
试验地点
1
主要终点
the number of secondary catheter failures

研究概览

简要总结

Objective: Continuous nerve block (freezing the nerve) is needed for knee replacement surgery to reduce pain, increase rehabilitation and discharge patients home fast. A lot of time, money and hospital resources are invested in inserting these catheters. The aim of this study is to compare two end points used for insertion of continuous femoral nerve block and to see which one results in fewer failures on the surgical ward.

Methodology: Patients having total knee replacement surgery will be recruited in this study. Patients will be randomized into two groups. The continuous femoral nerve block catheter will be inserted using ultrasound and nerve stimulation with two different end points (certain muscle contraction).

Patients will be followed on day 1 and 2 after surgery to observe which catheter fails, how much pain the patient suffers and how much painkiller the patients used.

详细描述

Background:

Continuous femoral nerve block (c FNB) is a widely used regional anesthetic technique for many lower limb operations. It provides superior pain relief, faster ambulation, and shorter hospital stay and less risk of side effects when compared with patient controlled analgesia (PCA).

Stimulating catheters (SC): SC were introduced back in 1999 to provide an objective end point to guide the catheter position by maintaining the desired evoked muscle response.

Stimulating catheter for continuous femoral nerve block: Salinas et al compared stimulating catheters vs. non-stimulating catheter in volunteers having femoral nerve block. They maintained a quadriceps evoked muscle twitch < 0.5 mA through the stimulating catheter . They reported a block success of 100% via the stimulating catheters versus 85% via the non-stimulating catheters (P = 0.07) and a much dense motor block and pain scores with SC as compared to NSC.

Motor responses of the femoral nerve: With peripheral nerve stimulation of the femoral nerve, two responses may be elicited, sartorius muscle contraction (contraction of the sartorius muscle through stimulation of its muscular branch) or quadriceps muscle contraction or patella twitch (contraction of the quadriceps muscle through stimulation its respective muscular branches). The two divisions of the femoral nerve are in fact medial and lateral divisions rather than anterior and posterior . The medial division supplies the sartorius muscle and the lateral division supplies the quadriceps muscle and both divisions lay within close proximity in the same fascial plane. Several regional anesthesia texts states that the anterior branch, supplying a motor branch to sartorius is above the fascia iliaca and this is partly why this stimulation should not be sought for FNB because there would be inadequate spread around the femoral nerve. An anatomical study by Gustafson et al and other anatomical text have forfeited this theory , . Furthermore, the rectus femoris of quadriceps often gets part of its innervation from the same division supplying the sartorius muscle.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Quadruple (Participant, Care Provider, Investigator, 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

入选标准

  • Patients having total knee arthroplasty AsA 1-3

排除标准

  • patients with a history of significant medical or psychiatric problems, BMI > 40, allergy to local anesthetic drugs, prior surgery in the inguinal region, neurological disease with sensory or motor deficit, and diabetic neuropathy.

结局指标

主要结局

the number of secondary catheter failures

时间窗: 12 months

to prevent the occurance of failed femoral nerve catheter on postoperative day 1

次要结局

  • total morphine consumption(12 months)

研究者

申办方类型
Other

研究点 (1)

Loading locations...

相似试验