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PRCT of FICB vs LAI for Hip Arthroscopy

Primary Purpose

Femoroacetabular Impingement

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Fascia Iliaca Compartment Block (FICB)
Local Anaesthetic Infiltration (LAI)
Levobupivacaine
Sponsored by
Cambridge University Hospitals NHS Foundation Trust
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Femoroacetabular Impingement focused on measuring Fascia Iliaca Block, Local Anaesthetic Infiltration, Hip Arthroscopy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    Procedure - FICB

    Procedure - LAI

    Arm Description

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

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

    Outcomes

    Primary Outcome Measures

    Level of pain as assessed by Numeric Pain Score

    Secondary Outcome Measures

    Frequency of morphine consumed
    Total dose of morphine consumed
    Total dose of codeine consumed
    Nausea and Vomiting

    Full Information

    First Posted
    February 24, 2016
    Last Updated
    March 10, 2016
    Sponsor
    Cambridge University Hospitals NHS Foundation Trust
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02702661
    Brief Title
    PRCT of FICB vs LAI for Hip Arthroscopy
    Official Title
    Fascia Iliaca Compartment Block and Local Anaesthetic Infiltration for Pain Control Following Hip Arthroscopic Surgery
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    March 2016
    Overall Recruitment Status
    Completed
    Study Start Date
    March 2013 (undefined)
    Primary Completion Date
    November 2013 (Actual)
    Study Completion Date
    April 2014 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Cambridge University Hospitals NHS Foundation Trust

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Femoroacetabular Impingement
    Keywords
    Fascia Iliaca Block, Local Anaesthetic Infiltration, Hip Arthroscopy

    7. Study Design

    Primary Purpose
    Supportive Care
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    Participant
    Allocation
    Randomized
    Enrollment
    46 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Procedure - FICB
    Arm Type
    Experimental
    Arm Description
    Fascia Iliaca Block following Hip Arthroscopy - Drug - Levobupivacaine 0.125% - 40ml
    Arm Title
    Procedure - LAI
    Arm Type
    Active Comparator
    Arm Description
    Local Anaesthetic Infiltration following Hip Arthroscopy - Drug - Levobupivacaine 0.125% - 40ml
    Intervention Type
    Procedure
    Intervention Name(s)
    Fascia Iliaca Compartment Block (FICB)
    Intervention Description
    Fascia Iliaca Compartment Block
    Intervention Type
    Procedure
    Intervention Name(s)
    Local Anaesthetic Infiltration (LAI)
    Intervention Description
    Local Anaesthetic Infiltration (LAI) of the portal tracts
    Intervention Type
    Drug
    Intervention Name(s)
    Levobupivacaine
    Intervention Description
    Levobupivacaine 0.125% - 40ml
    Primary Outcome Measure Information:
    Title
    Level of pain as assessed by Numeric Pain Score
    Time Frame
    6 hours after surgery
    Secondary Outcome Measure Information:
    Title
    Frequency of morphine consumed
    Time Frame
    1 and 24 hours after surgery
    Title
    Total dose of morphine consumed
    Time Frame
    1 and 24 hours after surgery
    Title
    Total dose of codeine consumed
    Time Frame
    1 and 24 hours after surgery
    Title
    Nausea and Vomiting
    Time Frame
    1 and 24 hours after surgery

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    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
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Vikas Khanduja, MA, FRCS (Orth)
    Organizational Affiliation
    Cambridge University Hospitals NHS Foundation Trust
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

    PRCT of FICB vs LAI for Hip Arthroscopy

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