Back to resultsRegional Anesthesia in Hip Arthroscopy
Primary Purpose
Femoroacetabular Impingement
Status
Withdrawn
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
regional anesthesia bupivacaine
regional anesthesia placebo
Sponsored by
About this trial
This is an interventional health services research trial for Femoroacetabular Impingement
Eligibility Criteria
Inclusion Criteria:
- Patient undergoing primary hip arthroscopy with labral repair and osteoplasty for hip impingement
- Age 18-45 years old
- Not pregnant
- No history of neuropathic pain
- No radiographic signs of osteoarthritis of the operative hip (Tönnisgrade 1)
- Willing and able to comply with post-operative hip arthroscopy protocol
- No documented allergy to anesthetic agents
- Able to attend follow up appointments
Exclusion Criteria:
- Allergy to regional anesthetic
- Age <18 or >45 years
- Pregnant females
- History of neuropathic pain
- Radiographic signs of osteoarthritis (Tönnis grade 2)
- Unable to speak/understand English
- Currently imprisoned
- Unwilling/unable to provide consent
Sites / Locations
- University of Missouri Health System
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
regional anesthesia bupivacaine
regional anesthesia placebo
Arm Description
regional anesthesia (a single shot fascia iliaca block using bupivacaine) prior to hip arthroscopy
subcutaneous injection procedure placebo (0.9% sodium chloride in water)
Outcomes
Primary Outcome Measures
Subject log to record number of pain pills taken by subject for 7 days
A log that is used by the subject to record how many oral pain medications they take for 7 days.
Secondary Outcome Measures
Record of Pain Medication given in PACU
Record narcotic requirements in PACU
Harris Hip score
Patient reported outcome. These will be completed at the pre-operative and all post-operative clinic visits.
Visual analog pain scale
Patient reported outcome. These will be completed at the pre-operative and all post-operative clinic visits.
iHOT-12 (international hip outcome tool)
Patient reported outcome. These will be completed at the pre-operative and all post-operative clinic visits.
HOOS (hip disability and osteoarthritis outcome score)
Patient reported outcome. These will be completed at the pre-operative and all post-operative clinic visits.
Duration of time in PACU
Reported Falls Post-op
Unplanned admissions and/or readmissions
number of unplanned admissions/readmission
Days until starting rehabilitation
Patient satisfaction
Full Information
NCT ID
NCT02674113
First Posted
November 7, 2015
Last Updated
February 9, 2017
Sponsor
University of Missouri-Columbia
1. Study Identification
Unique Protocol Identification Number
NCT02674113
Brief Title
Regional Anesthesia in Hip Arthroscopy
Official Title
Use of Regional Anesthesia in Hip Arthroscopy
Study Type
Interventional
2. Study Status
Record Verification Date
February 2017
Overall Recruitment Status
Withdrawn
Why Stopped
determined not to be feasible at our site
Study Start Date
October 2015 (undefined)
Primary Completion Date
October 2017 (Anticipated)
Study Completion Date
October 2017 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Missouri-Columbia
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The purpose of this research is to determine differences in outcomes in patients who receive regional anesthesia (a fascia iliaca block) versus placebo prior to undergoing hip arthroscopy with labral repair and/or debridement and osteoplasty for hip impingement.
Detailed Description
Methods: After informed consent is obtained at a routine/pre-surgical clinic visit, all patients who meet eligibility criteria will undergo randomization into one of two groups. These groups are 1) to receive regional anesthesia (a single shot fascia iliaca block using bupivacaine) prior to hip arthroscopy, or 2) undergo a subcutaneous injection procedure using a normal saline placebo (0.9% sodium chloride in water) instead of bupivacaine. Intra-operatively, both groups will receive general anesthesia and local anesthesia (lidocaine and bupivacaine in the peripheral compartment).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Femoroacetabular Impingement
7. Study Design
Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
regional anesthesia bupivacaine
Arm Type
Active Comparator
Arm Description
regional anesthesia (a single shot fascia iliaca block using bupivacaine) prior to hip arthroscopy
Arm Title
regional anesthesia placebo
Arm Type
Placebo Comparator
Arm Description
subcutaneous injection procedure placebo (0.9% sodium chloride in water)
Intervention Type
Drug
Intervention Name(s)
regional anesthesia bupivacaine
Other Intervention Name(s)
Exparel, Sensorcaine, Marcaine
Intervention Description
a single shot fascia iliaca block using bupivacaine prior to hip arthroscopy
Intervention Type
Drug
Intervention Name(s)
regional anesthesia placebo
Other Intervention Name(s)
Sodium Chloride Injection
Intervention Description
subcutaneous injection procedure using a normal saline placebo (0.9% sodium chloride in water)
Primary Outcome Measure Information:
Title
Subject log to record number of pain pills taken by subject for 7 days
Description
A log that is used by the subject to record how many oral pain medications they take for 7 days.
Time Frame
7 days
Secondary Outcome Measure Information:
Title
Record of Pain Medication given in PACU
Description
Record narcotic requirements in PACU
Time Frame
immediately post-op (while in PACU, on average 1-4 hours total)
Title
Harris Hip score
Description
Patient reported outcome. These will be completed at the pre-operative and all post-operative clinic visits.
Time Frame
6 weeks
Title
Visual analog pain scale
Description
Patient reported outcome. These will be completed at the pre-operative and all post-operative clinic visits.
Time Frame
6 weeks
Title
iHOT-12 (international hip outcome tool)
Description
Patient reported outcome. These will be completed at the pre-operative and all post-operative clinic visits.
Time Frame
6 weeks
Title
HOOS (hip disability and osteoarthritis outcome score)
Description
Patient reported outcome. These will be completed at the pre-operative and all post-operative clinic visits.
Time Frame
6 weeks
Title
Duration of time in PACU
Time Frame
immediately post-op, on average between 1-4 hours
Title
Reported Falls Post-op
Time Frame
Time inpatient, on average 12-48 hours
Title
Unplanned admissions and/or readmissions
Description
number of unplanned admissions/readmission
Time Frame
6 weeks
Title
Days until starting rehabilitation
Time Frame
immediately post-op, on average 24 hours - 2 weeks
Title
Patient satisfaction
Time Frame
6 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Patient undergoing primary hip arthroscopy with labral repair and osteoplasty for hip impingement
Age 18-45 years old
Not pregnant
No history of neuropathic pain
No radiographic signs of osteoarthritis of the operative hip (Tönnisgrade 1)
Willing and able to comply with post-operative hip arthroscopy protocol
No documented allergy to anesthetic agents
Able to attend follow up appointments
Exclusion Criteria:
Allergy to regional anesthetic
Age <18 or >45 years
Pregnant females
History of neuropathic pain
Radiographic signs of osteoarthritis (Tönnis grade 2)
Unable to speak/understand English
Currently imprisoned
Unwilling/unable to provide consent
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ajay Aggarwal, MD
Organizational Affiliation
University of Missouri Health System
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Missouri Health System
City
Columbia
State/Province
Missouri
ZIP/Postal Code
65212
Country
United States
12. IPD Sharing Statement
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Regional Anesthesia in Hip Arthroscopy
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