Clinical Trials Logo

Clinical Trial Details — Status: Withdrawn

Administrative data

NCT number NCT02674113
Other study ID # 1211908
Secondary ID
Status Withdrawn
Phase N/A
First received November 7, 2015
Last updated February 9, 2017
Start date October 2015
Est. completion date October 2017

Study information

Verified date February 2017
Source University of Missouri-Columbia
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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 information / eligibility

Status Withdrawn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

Study Design


Intervention

Drug:
regional anesthesia bupivacaine
a single shot fascia iliaca block using bupivacaine prior to hip arthroscopy
regional anesthesia placebo
subcutaneous injection procedure using a normal saline placebo (0.9% sodium chloride in water)

Locations

Country Name City State
United States University of Missouri Health System Columbia Missouri

Sponsors (1)

Lead Sponsor Collaborator
University of Missouri-Columbia

Country where clinical trial is conducted

United States, 

Outcome

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
See also
  Status Clinical Trial Phase
Completed NCT01623843 - Femoroacetabular Impingement RandomiSed Controlled Trial N/A
Completed NCT03669471 - Muscular and Functional Performance in FAIS Patients
Not yet recruiting NCT05031390 - the Horsens Aarhus FemoroAcetabular Impingement Syndrome Training Pilot Study N/A
Active, not recruiting NCT05025956 - Senolytic Agent Improve the Benefit of Platelet-Rich Plasma and Losartan Phase 1/Phase 2
Withdrawn NCT02260726 - Evaluation of Ultrasound for Detecting Hip Impingement N/A
Recruiting NCT05391204 - Reproducibility of Strength Testing and Functional Testing of the Hip for the Return to Sport of Patients Activated by a Femoroacetabular Impingement: Comparison Between a Group of Patients and a Group of Healthy Controls N/A
Active, not recruiting NCT03891563 - Prospective Evaluation of Sport Activity and the Development of Femoroacetabular Impingement in the Adolescent Hip
Active, not recruiting NCT04069507 - Healthy Hip Study: Conservative Management for Pre-arthritic Hip Disorders
Terminated NCT03278353 - Fulfillment of Expectations for Patients With FAI Syndrome N/A
Terminated NCT03995290 - 3D Modeling to Improve Hip Arthroscopy Outcomes
Completed NCT06082271 - Comparative, Randomized Study on the Anti-inflammatory and Regenerative Efficacy of a New Medical Device (DM) Based on Hydrolyzed Collagen Peptides in Patients With Femoro-acetabular Impingement Undergoing Hip Arthroscopy N/A
Recruiting NCT01621360 - Hip Arthroscopy Versus Conservative Management of Femoroacetabular Impingement N/A
Completed NCT04980209 - The Feasibility and Application of Intraoperative Ultrasound to Evaluate Femoral Head Shaping
Enrolling by invitation NCT04988659 - Analysis of Gene Expression in Femoroacetabular Impingement (FAI)
Active, not recruiting NCT03494660 - SCP Hip Outcomes Study
Active, not recruiting NCT04822571 - Investigating the Reliability of Highly Dynamic 3D Motion Analysis Protocol in Adolescence and Adult Males N/A
Withdrawn NCT02706756 - Conservative Intervention of Femoroacetabular Impingement Syndrome N/A
Completed NCT01814124 - Conservative Management of Femoroacetabular Impingement N/A
Completed NCT02702661 - PRCT of FICB vs LAI for Hip Arthroscopy N/A
Completed NCT01993615 - A Physical Therapy Program Versus Surgery for Femoroacetabular Impingement: Randomized Clinical Trial N/A