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临床试验/NCT02788019
NCT02788019终止4 期

Adductor Canal Mid-thigh and Adductor Canal Distal Thigh: Is Cutaneous Sensory Blockade Similar Among Block Techniques?

University of Texas Southwestern Medical Center1 个研究点 分布在 1 个国家目标入组 52 人开始时间: 2016年5月26日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
4 期
状态
终止
入组人数
52
试验地点
1
主要终点
Number of Grid Points With Change of Sensation to Pinprick After Blockade

研究概览

简要总结

This is a randomized noninferiority interventional study to determine the equivalence of two adductor canal block (ACB) methods: mid-thigh and distal thigh in patients undergoing medial foot, medial ankle, or medial leg surgery. Sixty eight patients will be identified during their orthopedic presurgical clinic visit, anesthesia preoperative clinic visit or Day Surgery Unit (Zale Lipshy Hospital, Clements University Hospital, and University of Texas Southwestern Outpatient Surgery Center) for eligibility. Eligible individuals may be introduced to the study in the orthopedic presurgical clinic or the anesthesia preoperative clinic by staff. After consent patients will be randomized (break-seal method) to receive either a mid-thigh or distal thigh block using ropivacaine prior to foot, ankle, or leg surgery. The following measurements will be obtained to determine the change in sensory distribution: pinprick test with Neuropen, maximum voluntary isometric contraction before and after block, postoperative pain scores (24 hrs and at discharge) and postoperative opiate consumption.

详细描述

Potential subjects will be identified at the orthopedic presurgical clinic, the anesthesia preoperative clinic or the Day Surgery Unit. The electronic medical record (Epic) will also be used for prescreening potential subjects. Recruitment and consenting at will occur at anesthesia preoperative clinics, Day Surgery Unit. A computer generated randomization list will be used for randomization list. The research intervention of this study will take place within the standard clinical context. The patient will receive an ACB regardless of their participation in this research in accordance with their anesthetic plan and their desires The experiment will be conducted as follows: A 20-point grid will be drawn on the subject's leg that will receive medial foot, ankle or leg surgery. Two baseline measurements will be taken prior to administration of the adductor block: distribution of sensation using pinprick (Neuropen) method, and muscle contraction strength using a dynamometer. The number of grid cells with sensation will be counted and recorded. The randomized block will be administered allowing 20 minutes for anesthetic to take full effect. Post-block measurements include pinprick in each of the grid cells, where patient will indicate whether sensation is felt or not. The cells where sensation is perceived will be circled and number of cells will be recorded. After sensation is recorded, maximum voluntary isometric contraction (MVIC) will again be measured with the dynamometer to record the maximal contraction strength. Within 24 hours of surgery, the subject will be asked to rate their pain on a scale of 0-10, and will be recorded again after discharge, in conjunction with opiates required to reduce pain. A more detailed explanation of experimental steps can be read below.

20-Point Grid: The 20-point grid will be marked starting with anatomical landmarks at the knee joint: the medial inter-knee joint where the tibia meets the femur, the mid medial patella, the mid lateral patella, and along the same line at the semitendinosus tendon at 5 cm posterior from that point. Then 5 cm intervals will be plotted progressing cephalad to a total of 15 cm.

Neuropen test:

Prior to administration of randomized blockade technique a pinprick test will be administered using a Neuropen on a scale of 0-1, with 1-normal sharp sensation and 0=dull change of sensation. Mechanical stimulation with pinprick testing is routinely used to test nociception in the bedside neurologic examination. Sharpness can be considered a surrogate for nociception because whereas sharpness is not necessarily painful, mechanical thresholds for sharpness closely parallel those for pain. The subject will be asked to determine whether the stimulus feels sharp. The number of grid-points with a change in sensation from baseline will be recorded at baseline and 20 minutes after the block.

MVIC:

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 (Participant)

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

  • Adults aged 18 years or older
  • Individuals undergoing surgery of the medial foot, medial ankle, or medial leg for which the anesthetic plan includes an adductor canal nerve block

排除标准

  • Any known deficit of the ipsilateral lumbar nerve roots, ipsilateral lumbar plexus, ipsilateral femoral nerve, obturator nerve or saphenous nerve including diabetic peripheral neuropathy
  • Any local disorder of the skin or otherwise where blockade is to be performed
  • Body mass index >50
  • American Society of Anesthesiologists (ASA) classification greater than 3
  • Allergy to amide local anesthetic medications
  • Incarceration
  • Inability to understand study procedures including inability to understand the English language

研究组 & 干预措施

Mid-Thigh Adductor Block

Experimental

Subject will receive a mid-thigh adductor block method using ropivacaine (0.5%, 15 mL).

干预措施: Ropivacaine (Drug)

Distal-Thigh Adductor Block

Active Comparator

Subject will receive a distal-thigh adductor block method using ropivacaine (0.5%, 15 mL).

干预措施: Ropivacaine (Drug)

结局指标

主要结局

Number of Grid Points With Change of Sensation to Pinprick After Blockade

时间窗: 20 minutes

The distribution of cutaneous sensation affected by the different techniques of adductor canal blockade is assessed using a monofilament Neuropen to prick points on a 20 point grid applied to the skin in a standard fashion according to this method: A grid will be marked starting with anatomical landmarks at the knee joint: the medial inter-knee-joint point where the tibia meets the femur, the mid medial patella, the mid lateral patella, and along the same line at the semitendinosus tendon and 5cm posterior from that point. Then 5cm intervals will be plotted progressing cephalad to a total of 15 centimeters. This will yield 20 grid points (5x4 points). Once the grid is made, testing proceeds with a Neuropen on a scale of 0-1, with 1 = normal sharp sensation, 0 = change of sensation. The Neuropen is used for the standardization of force.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Anthony Machi

Assistant Professor

University of Texas Southwestern Medical Center

研究点 (1)

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