Femoroacetabular Impingement Clinical Trial
Official title:
Use of Regional Anesthesia in Hip Arthroscopy
Verified date | February 2017 |
Source | University of Missouri-Columbia |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Withdrawn |
Enrollment | 0 |
Est. completion date | October 2017 |
Est. primary completion date | October 2017 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years to 45 Years |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
United States | University of Missouri Health System | Columbia | Missouri |
Lead Sponsor | Collaborator |
---|---|
University of Missouri-Columbia |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | Record of Pain Medication given in PACU | Record narcotic requirements in PACU | immediately post-op (while in PACU, on average 1-4 hours total) | |
Secondary | Harris Hip score | Patient reported outcome. These will be completed at the pre-operative and all post-operative clinic visits. | 6 weeks | |
Secondary | Visual analog pain scale | Patient reported outcome. These will be completed at the pre-operative and all post-operative clinic visits. | 6 weeks | |
Secondary | iHOT-12 (international hip outcome tool) | Patient reported outcome. These will be completed at the pre-operative and all post-operative clinic visits. | 6 weeks | |
Secondary | HOOS (hip disability and osteoarthritis outcome score) | Patient reported outcome. These will be completed at the pre-operative and all post-operative clinic visits. | 6 weeks | |
Secondary | Duration of time in PACU | immediately post-op, on average between 1-4 hours | ||
Secondary | Reported Falls Post-op | Time inpatient, on average 12-48 hours | ||
Secondary | Unplanned admissions and/or readmissions | number of unplanned admissions/readmission | 6 weeks | |
Secondary | Days until starting rehabilitation | immediately post-op, on average 24 hours - 2 weeks | ||
Secondary | Patient satisfaction | 6 weeks |
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