PRCT of FICB vs LAI for Hip Arthroscopy

Not Applicable

Completed

• Conditions: Femoroacetabular Impingement
• Interventions: Procedure: Fascia Iliaca Compartment Block (FICB); Procedure: Local Anaesthetic Infiltration (LAI); Drug: Levobupivacaine

• Registration Number: NCT02702661
• Lead Sponsor: Cambridge University Hospitals NHS Foundation Trust

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-03
• Primary Completion: 2013-11
• Study Completion: 2014-04
• Study First Submitted: 2016-02-24
• Status Verified: 2016-03
• Study First Submitted QC: 2016-03-03
• Study First Posted: 2016-03-09
• Last Update Submitted: 2016-03-10
• Last Update Posted: 2016-03-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 46

Inclusion Criteria

• 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

Exclusion Criteria

• 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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Procedure - FICB	Fascia Iliaca Compartment Block (FICB)	Fascia Iliaca Block following Hip Arthroscopy - Drug - Levobupivacaine 0.125% - 40ml
Procedure - LAI	Local Anaesthetic Infiltration (LAI)	Local Anaesthetic Infiltration following Hip Arthroscopy - Drug - Levobupivacaine 0.125% - 40ml
Procedure - FICB	Levobupivacaine	Fascia Iliaca Block following Hip Arthroscopy - Drug - Levobupivacaine 0.125% - 40ml
Procedure - LAI	Levobupivacaine	Local Anaesthetic Infiltration following Hip Arthroscopy - Drug - Levobupivacaine 0.125% - 40ml

Primary Outcome Measures

Name	Time	Method
Level of pain as assessed by Numeric Pain Score	6 hours after surgery

Secondary Outcome Measures

Name	Time	Method
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