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临床试验/NCT02882633
NCT02882633已完成不适用

Lumbar Plexus Block vs Fascia Iliaca Block After Hip Arthroscopy: A Non-inferiority Study

University of Pennsylvania1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2015年11月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
已完成
入组人数
50
试验地点
1
主要终点
Amount of Opiate Consumption

研究概览

简要总结

The purpose of this study is to compare lumbar plexus block to fascia iliac block done in adult patients who have undergone hip arthroscopy surgery. Visual analogue scores, opioid consumption, and quality of recovery 48 hours post operatively will be used for comparison.

详细描述

If the patient is willing to participate and signs the consent, he/she will be randomized to one of the two treatment groups:

  1. Lumbar Plexus Block
  2. Fascia Iliaca Block

The patient will undergo general anesthesia as by the attending anesthesiologist assigned to the case. No intraoperative restrictions will be required for this study. Once in the PACU, the patient will be assessed and if their pain score is ≥ 4 on the NRS, the patient will be randomized to a lumbar plexus block or fascia iliaca block.

Patients will be monitored during block performance with standard ASA monitors. All patients will receive 2 L of oxygen via a nasal cannula. Sedatives will be titrated to effect. Midazolam 1-2 mg, and fentanyl 50-100 mcg will be used for sedation.

The fascia iliaca block will be performed in a standard fashion as described2. The patient will be placed in a supine position. The ipsilateral groin will be prepped and cleaned with chlorhexidine. An ultrasound machine with a linear transducer covered with a sterile tegaderm will be utilized. The transducer is placed inferior to the inguinal ligament until the femoral artery is located. The probe is then moved laterally until the Sartorius muscle is seen. A skin wheal with 3ml of 1% lidocaine is made and a 2-inch blunt tip needle is inserted in plane. The needle is seen to pierce the fascia iliaca and 1-2 ml of 0.25% Preservative Free bupivacaine with 1:200,000 epinephrine is injected to confirm correct needle placement between the fascia iliaca and iliopsoas muscle. An injection will be deemed adequate if local anesthetic is seen to separate these two layers in a medial to lateral direction. A total of 30ml of the above solution will be injected.

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
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Adult patients18 years and older scheduled for hip arthroscopy surgery
  • American Society of Anesthesiologists (ASA) physical status I -III
  • Mentally competent and able to give consent for enrollment in the study

排除标准

  • Chronic opioid use (use of any opioid daily or on most days of the week for more than 3 months)
  • Diagnosed peripheral neuropathy in the surgical lower extremity
  • Allergy to study medications

研究组 & 干预措施

Lumbar Plexus Block

Active Comparator

Subjects will receive single shot local anesthetic, 30 ml bolus of bupivacaine, given preoperatively to help with postoperative pain

干预措施: 30ml bolus of bupivacaine (Drug)

Fascia Iliac Block

Active Comparator

Subjects will receive single shot local anesthetic, 30 ml bolus of bupivacaine, given preoperatively to help with postoperative pain

干预措施: 30ml bolus of bupivacaine (Drug)

结局指标

主要结局

Amount of Opiate Consumption

时间窗: While in PACU. An average length of stay for Lumbar Plexus Block group was 165.04 min and 139.72 min for Fascia Iliaca Block group.

Participants need for pain relief as measured by opiate consumption

Pain Score Change

时间窗: Change from baseline through 15 minutes

Change in pain scores, as measured by the Visual Analog Scale (0-10). 10 is worst imaginable pain and 0 means no pain at all.

次要结局

  • Quality of Recovery(Change from baseline through 24 hours)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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