Regional Anesthesia in Hip Arthroscopy
- Conditions
- Femoroacetabular Impingement
- Interventions
- Drug: regional anesthesia placebo
- Registration Number
- NCT02674113
- Lead Sponsor
- University of Missouri-Columbia
- 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).
Recruitment & Eligibility
- Status
- WITHDRAWN
- Sex
- All
- Target Recruitment
- Not specified
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description regional anesthesia bupivacaine regional anesthesia bupivacaine regional anesthesia (a single shot fascia iliaca block using bupivacaine) prior to hip arthroscopy regional anesthesia placebo regional anesthesia placebo subcutaneous injection procedure placebo (0.9% sodium chloride in water)
- Primary Outcome Measures
Name Time Method Subject log to record number of pain pills taken by subject for 7 days 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
Name Time Method Duration of time in PACU immediately post-op, on average between 1-4 hours Visual analog pain scale 6 weeks Patient reported outcome. These will be completed at the pre-operative and all post-operative clinic visits.
Reported Falls Post-op Time inpatient, on average 12-48 hours iHOT-12 (international hip outcome tool) 6 weeks Patient reported outcome. These will be completed at the pre-operative and all post-operative clinic visits.
Record of Pain Medication given in PACU immediately post-op (while in PACU, on average 1-4 hours total) Record narcotic requirements in PACU
Harris Hip score 6 weeks Patient reported outcome. These will be completed at the pre-operative and all post-operative clinic visits.
Unplanned admissions and/or readmissions 6 weeks number of unplanned admissions/readmission
HOOS (hip disability and osteoarthritis outcome score) 6 weeks Patient reported outcome. These will be completed at the pre-operative and all post-operative clinic visits.
Days until starting rehabilitation immediately post-op, on average 24 hours - 2 weeks Patient satisfaction 6 weeks
Trial Locations
- Locations (1)
University of Missouri Health System
🇺🇸Columbia, Missouri, United States
University of Missouri Health System🇺🇸Columbia, Missouri, United States