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
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
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
NCT ID
NCT02702661
First Posted
February 24, 2016
Last Updated
March 10, 2016
Sponsor
Cambridge University Hospitals NHS Foundation Trust
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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