Use of Regional Anesthesia in Hip Arthroscopy
1 other identifier
interventional
70
1 country
1
Brief Summary
The purpose of this research is to determine differences in outcomes in patients who do, or do not, receive regional anesthesia (a fascia iliaca block) 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
participants targeted
Target at P25-P50 for phase_4
Started Jul 2016
Typical duration for phase_4
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 2016
CompletedFirst Submitted
Initial submission to the registry
July 26, 2016
CompletedFirst Posted
Study publicly available on registry
August 2, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2018
CompletedFebruary 19, 2018
November 1, 2017
1.8 years
July 26, 2016
February 14, 2018
Conditions
Outcome Measures
Primary Outcomes (1)
Pain Medication Requirement in PACU
Measured in morphine equivalents
24 hours post-operatively
Secondary Outcomes (9)
Falls
6 weeks
Readmissions
6 weeks
Neuropathic Pain
2 weeks and 6 weeks
Time to Physical Therapy
6 weeks
Duration of PACU stay (mins)
24 hours post-operatively
- +4 more secondary outcomes
Study Arms (2)
Iliac Fascia Block (Ropivacaine)
EXPERIMENTALThese patients will receive a preoperative iliac fascia block performed as a single shot in the standard fashion prior to hip arthroscopy with general anesthesia.
Control (Normal Saline Sham Injection)
SHAM COMPARATORThese patients will receive a preoperative sham block of normal saline in the same fashion as a standard singl shot iliac fascia block prior to hip arthroscopy with general anesthesia.
Interventions
Iliac fascia block was performed in the experimental group with a single shot of Ropavicaine.
Sham block using normal saline instead of iliac fascia block but otherwise employing the equivalent technique.
Patients were induced and maintained in a fashion consistent with standard practices.
Eligibility Criteria
You may qualify if:
- Scheduled for arthroscopic labral repair with or without osteoplasty of the hip.
- to 50 years old
- American Society of Anesthesiologists Physical Status (ASA PS) score of I or II.
You may not qualify if:
- Current or planned pregnancy
- History of neuropathic pain, chronic pain syndrome, or preoperative use of narcotic or neuropathic pain medicine
- Radiographic signs of osteoarthritis (\> Tonis grade 1)
- Inability to attend follow up visits
- Documented allergy to local anesthetic
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Georgetown Universitylead
- Union Memorial Hospitalcollaborator
Study Sites (1)
Georgetown University Medical Center
Washington D.C., District of Columbia, 20007, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Blake Bodendorfer, MD
Georgetown University
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 26, 2016
First Posted
August 2, 2016
Study Start
July 1, 2016
Primary Completion
April 1, 2018
Study Completion
August 1, 2018
Last Updated
February 19, 2018
Record last verified: 2017-11
Data Sharing
- IPD Sharing
- Will not share