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临床试验/NCT02702661
NCT02702661已完成不适用

Fascia Iliaca Compartment Block and Local Anaesthetic Infiltration for Pain Control Following Hip Arthroscopic Surgery

Cambridge University Hospitals NHS Foundation Trust0 个研究点目标入组 46 人开始时间: 2013年3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
46
主要终点
Level of pain as assessed by Numeric Pain Score

研究概览

简要总结

A prospective randomised controlled trial involving patients undergoing hip arthroscopy. Participants were randomised to receiving either Fascia Iliaca Compartment Block (FICB) or Local Anaesthetic Infiltration (LAI) of the portal tracts with local anaesthetic. Supplemental analgesia was also used in both groups on an on-demand basis. Pain level is assessed at 1,3,6, and 24 hours post surgery. The primary outcome measure was the post-operative level of pain as assessed by Numeric Pain Score 6 hours after surgery. Secondary outcome measures were the frequency and the dose of morphine and other medications consumed at 1 and 24 hours after surgery as well as any other adverse events relating to pain or medications used for pain relief in both the groups.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
Single (Participant)

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

  • Patients over the age of 18 years
  • Primary elective hip arthroscopy on a native hip for combined soft tissue injuries and FAI pathology
  • Able to read, write and communicate in English

排除标准

  • Patients who did not want to be involved in the Trial
  • Unable to give informed consent
  • Previous hip surgery
  • Patients younger than 18 years of age
  • Chronic opioids users
  • Patients known to have an allergy or intolerance to local anaesthetic agents or none steroidal anti-inflammatory medications

研究组 & 干预措施

Procedure - FICB

Experimental

Fascia Iliaca Block following Hip Arthroscopy - Drug - Levobupivacaine 0.125% - 40ml

干预措施: Fascia Iliaca Compartment Block (FICB) (Procedure)

Procedure - FICB

Experimental

Fascia Iliaca Block following Hip Arthroscopy - Drug - Levobupivacaine 0.125% - 40ml

干预措施: Levobupivacaine (Drug)

Procedure - LAI

Active Comparator

Local Anaesthetic Infiltration following Hip Arthroscopy - Drug - Levobupivacaine 0.125% - 40ml

干预措施: Local Anaesthetic Infiltration (LAI) (Procedure)

Procedure - LAI

Active Comparator

Local Anaesthetic Infiltration following Hip Arthroscopy - Drug - Levobupivacaine 0.125% - 40ml

干预措施: Levobupivacaine (Drug)

结局指标

主要结局

Level of pain as assessed by Numeric Pain Score

时间窗: 6 hours after surgery

次要结局

  • Total dose of codeine consumed(1 and 24 hours after surgery)
  • Nausea and Vomiting(1 and 24 hours after surgery)
  • Total dose of morphine consumed(1 and 24 hours after surgery)
  • Frequency of morphine consumed(1 and 24 hours after surgery)

研究者

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

Vikas Khanduja MA FRCS (Orth)

Consultant Orthopaedic Surgeon & Associate Lecturer

Cambridge University Hospitals NHS Foundation Trust

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