PRCT of FICB vs LAI for Hip Arthroscopy

NCT ID: NCT02702661

Last Updated: 2016-03-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

46 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-03-31

Study Completion Date

2014-04-30

Brief Summary

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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

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Conditions

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Femoroacetabular Impingement

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

SINGLE

Participants

Study Groups

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Procedure - FICB

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

Group Type EXPERIMENTAL

Fascia Iliaca Compartment Block (FICB)

Intervention Type PROCEDURE

Fascia Iliaca Compartment Block

Levobupivacaine

Intervention Type DRUG

Levobupivacaine 0.125% - 40ml

Procedure - LAI

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

Group Type ACTIVE_COMPARATOR

Local Anaesthetic Infiltration (LAI)

Intervention Type PROCEDURE

Local Anaesthetic Infiltration (LAI) of the portal tracts

Levobupivacaine

Intervention Type DRUG

Levobupivacaine 0.125% - 40ml

Interventions

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Fascia Iliaca Compartment Block (FICB)

Fascia Iliaca Compartment Block

Intervention Type PROCEDURE

Local Anaesthetic Infiltration (LAI)

Local Anaesthetic Infiltration (LAI) of the portal tracts

Intervention Type PROCEDURE

Levobupivacaine

Levobupivacaine 0.125% - 40ml

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Cambridge University Hospitals NHS Foundation Trust

OTHER

Sponsor Role lead

Responsible Party

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Vikas Khanduja MA FRCS (Orth)

Consultant Orthopaedic Surgeon & Associate Lecturer

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Vikas Khanduja, MA, FRCS (Orth)

Role: STUDY_DIRECTOR

Cambridge University Hospitals NHS Foundation Trust

Other Identifiers

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A092336

Identifier Type: -

Identifier Source: org_study_id

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