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临床试验/NCT02299271
NCT02299271终止4 期

Fascia Iliaca Block for Post-Operative Pain Control After Total Hip Arthroplasty: A Prospective, Randomized, Double-Blind, Placebo-Controlled Study

The Christ Hospital1 个研究点 分布在 1 个国家目标入组 72 人开始时间: 2014年6月最近更新:
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
72
试验地点
1
主要终点
Opioid Consumption

研究概览

简要总结

This study evaluates post-operative pain management and narcotic consumption in patients receiving a fascia iliaca block with local anesthetic versus patients receiving fascia iliaca block with saline for total hip arthroplasty.

详细描述

Although many improvements have been made in implant technology and surgical approaches for total hip arthroplasty, management of post-operative pain remains a major clinical issue. Inadequate pain control can lead to numerous unwanted side effects and limited physical function, especially in a older population. Most surgeons have adopted a multi-modality pain management approach using a variety of pharmaceuticals, including nerve block with local anesthetic. In the literature, there are a number of technical variations described for the fascia iliaca nerve block. At The Christ Hospital, Cincinnati, Ohio, anesthesiologists use a more proximal approach to the fasica iliaca block enabling a significantly easier cephalad spread of the local anesthetic into the pelvis targeting all three nerves; the femoral, lateral femoral cutaneous, and the obturator.

This prospective, double-blinded, randomized, single-center study is designed to test the primary hypothesis that fascia iliaca block with a local anesthestic decreases narcotic consumption and provides improved pain control compared to placebo in the first 24 hours after surgery in patients undergoing total hip arthroplasty.

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
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 75 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • anterior approach total hip arthroplasty (THA) for unilateral osteoarthritis
  • English-speaking
  • age 18 to 75 years
  • American Society of Anesthesiologists (ASA) physical status 1 to 3
  • BMI < 40 kg/m2
  • Minimum weight of 50 kg.
  • No contraindications to study procedures

排除标准

  • Hip revision surgery
  • Allergy to local anesthetics
  • Allergy to oxycontin
  • Allergy to pregabalin
  • Allergy to fentanyl
  • Allergy to midazolam
  • Allergy to hydromorphone
  • BMI > 40 kg/m2
  • Chronic pre-operative opioid use

研究组 & 干预措施

ropivacaine block

Active Comparator

Ropivacaine 0.375% as a one-time 60 milliliter injection.

干预措施: Ropivacaine (Drug)

saline block

Placebo Comparator

Sodium chloride 0.9% as a one-time 60 milliliter injection.

干预措施: Saline (Drug)

结局指标

主要结局

Opioid Consumption

时间窗: 24 hours

Measured by IV narcotic consumption beginning in the post-operative care unit and continuing 24 hours on the post-operative floor.

Pain Control

时间窗: 24 hours

Measured by NRS-11 beginning in post-operative care unit and continuing 24 hours on the post-operative floor.

次要结局

  • Post-Operative Care Unit (PACU) Length of Stay(From 60 minutes to 6 hours)

研究者

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

Brian Vaughan

Brian Vaughan, MD

The Christ Hospital

研究点 (1)

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