PRCT of FICB vs LAI for Hip Arthroscopy

March 10, 2016 updated by: Vikas Khanduja MA FRCS (Orth), Cambridge University Hospitals NHS Foundation Trust

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

46

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Procedure - FICB
Fascia Iliaca Block following Hip Arthroscopy - Drug - Levobupivacaine 0.125% - 40ml
Procedure: Fascia Iliaca Compartment Block (FICB)
Fascia Iliaca Compartment Block
Drug: Levobupivacaine
Levobupivacaine 0.125% - 40ml
Active Comparator: Procedure - LAI
Local Anaesthetic Infiltration following Hip Arthroscopy - Drug - Levobupivacaine 0.125% - 40ml
Drug: Levobupivacaine
Levobupivacaine 0.125% - 40ml
Procedure: Local Anaesthetic Infiltration (LAI)
Local Anaesthetic Infiltration (LAI) of the portal tracts

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Level of pain as assessed by Numeric Pain Score
Time Frame: 6 hours after surgery
6 hours after surgery

Secondary Outcome Measures

Outcome Measure
Time Frame
Frequency of morphine consumed
Time Frame: 1 and 24 hours after surgery
1 and 24 hours after surgery
Total dose of morphine consumed
Time Frame: 1 and 24 hours after surgery
1 and 24 hours after surgery
Total dose of codeine consumed
Time Frame: 1 and 24 hours after surgery
1 and 24 hours after surgery
Nausea and Vomiting
Time Frame: 1 and 24 hours after surgery
1 and 24 hours after surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cambridge University Hospitals NHS Foundation Trust

Investigators

  • Study Director: Vikas Khanduja, MA, FRCS (Orth), Cambridge University Hospitals NHS Foundation Trust

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2013

Primary Completion (Actual)

November 1, 2013

Study Completion (Actual)

April 1, 2014

Study Registration Dates

First Submitted

February 24, 2016

First Submitted That Met QC Criteria

March 3, 2016

First Posted (Estimate)

March 9, 2016

Study Record Updates

Last Update Posted (Estimate)

March 11, 2016

Last Update Submitted That Met QC Criteria

March 10, 2016

Last Verified

March 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • A092336

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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