Clinical trial NCT02674113: Regional Anesthesia in Hip Arthroscopy
Official title: Use of Regional Anesthesia in Hip Arthroscopy
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Femoroacetabular Impingement
Lead sponsor: University of Missouri-Columbia
Sponsor class: OTHER
First posted: 2016-02-04
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

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).

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

Primary outcomes:
measure: Subject log to record number of pain pills taken by subject for 7 days
timeFrame: 7 days
Secondary outcomes:
measure: Record of Pain Medication given in PACU
timeFrame: immediately post-op (while in PACU, on average 1-4 hours total)
measure: Harris Hip score
timeFrame: 6 weeks
measure: Visual analog pain scale
timeFrame: 6 weeks
measure: iHOT-12 (international hip outcome tool)
timeFrame: 6 weeks
measure: HOOS (hip disability and osteoarthritis outcome score)
timeFrame: 6 weeks
measure: Duration of time in PACU
timeFrame: immediately post-op, on average between 1-4 hours
measure: Reported Falls Post-op
timeFrame: Time inpatient, on average 12-48 hours
measure: Unplanned admissions and/or readmissions
timeFrame: 6 weeks
measure: Days until starting rehabilitation
timeFrame: immediately post-op, on average 24 hours - 2 weeks
measure: Patient satisfaction
timeFrame: 6 weeks
Other outcomes:
Locations:
city: Columbia
country: United States
facility: University of Missouri Health System
state: Missouri
Study officials:
affiliation: University of Missouri Health System
name: Ajay Aggarwal, MD
role: PRINCIPAL_INVESTIGATOR
References: