Study Stopped
determined not to be feasible at our site
Regional Anesthesia in Hip Arthroscopy
Use of Regional Anesthesia in Hip Arthroscopy
1 other identifier
interventional
N/A
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
Started Oct 2015
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2015
CompletedFirst Submitted
Initial submission to the registry
November 7, 2015
CompletedFirst Posted
Study publicly available on registry
February 4, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2017
CompletedFebruary 10, 2017
February 1, 2017
2 years
November 7, 2015
February 9, 2017
Conditions
Outcome Measures
Primary Outcomes (1)
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.
7 days
Secondary Outcomes (10)
Record of Pain Medication given in PACU
immediately post-op (while in PACU, on average 1-4 hours total)
Harris Hip score
6 weeks
Visual analog pain scale
6 weeks
iHOT-12 (international hip outcome tool)
6 weeks
HOOS (hip disability and osteoarthritis outcome score)
6 weeks
- +5 more secondary outcomes
Study Arms (2)
regional anesthesia bupivacaine
ACTIVE COMPARATORregional anesthesia (a single shot fascia iliaca block using bupivacaine) prior to hip arthroscopy
regional anesthesia placebo
PLACEBO COMPARATORsubcutaneous injection procedure placebo (0.9% sodium chloride in water)
Interventions
a single shot fascia iliaca block using bupivacaine prior to hip arthroscopy
subcutaneous injection procedure using a normal saline placebo (0.9% sodium chloride in water)
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of Missouri Health System
Columbia, Missouri, 65212, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Ajay Aggarwal, MD
University of Missouri Health System
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, OUTCOMES ASSESSOR
- Purpose
- HEALTH SERVICES RESEARCH
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Assistant Professor of Orthopedic Surgery
Study Record Dates
First Submitted
November 7, 2015
First Posted
February 4, 2016
Study Start
October 1, 2015
Primary Completion
October 1, 2017
Study Completion
October 1, 2017
Last Updated
February 10, 2017
Record last verified: 2017-02