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NCT02947178 · ClinicalTrials.gov registry record · Phase 4
Hip Arthroscopy Pain Control Randomized Control Trial (RCT)
A Phase 4 study, sponsored by Walter Reed National Military Medical Center.
- Completed
- Registry status
- Phase 4
- Development phase
- 74
- Enrollment target
NCT02947178 is a Phase 4 study that has completed, run by Walter Reed National Military Medical Center. The registered enrollment target is 74 participants.
The verdict
NCT02947178, a Phase 4 study, has completed, sponsored by Walter Reed National Military Medical Center.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 74 participants
- Enrollment target
Study Summary
Femoroacetabular impingement is a pathologic process within the hip joint that results from a mechanical discord between the femoral head and neck and the acetabulum that results in chronic hip pain, hip labral tears and early progression of osteoarthritis of the hip.1, 2 Historically an open surgical hip dislocation was performed to treat patients with this condition, however with recent advances in arthroscopy, patients more commonly now undergo arthroscopic hip surgery. From a pain management standpoint, previous attempts to provide peri-operative analgesia included intraarticular or portal analgesic injections. More recently, regional anesthesia techniques are being employed to provide more reliable and longer lasting post-operative pain control.3, 4 Currently, there are several local anesthetics available for regional anesthesia. However, they only provide an average of 12-18 hours of post-operative pain control following a single injection.5 Bupivacaine is a local anesthetic that has been used for many years by multiple routes to control post-operative pain. A new formulation of the medication prolongs the release of the active ingredient after a single injection and has been shown to result in up to 72 hours of post-operative analgesia.6, 7 To the investigator's knowledge, there has not been any studies in the literature comparing a historical control local anesthetic to this new formulation of liposomal bupivacaine via a fascial iliaca regional soft tissue infiltration blockade to provide post operative pain control following hip arthroscopy.
Interventions
- DRUG Bupivacaine
- DRUG Liposomal Bupivacaine
- PROCEDURE Fascial iliac regional soft tissue infiltration blockade
- BEHAVIORAL Pain Score Survey
- BEHAVIORAL Pill Count
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 74 participants |
| Start Date | 2016-03-01 |
| Est. Completion | 2017-03-01 |
| Phase | Phase 4 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02947178
The ClinicalTrials.gov registry entry for NCT02947178 describes a study currently listed as completed, categorized as Phase 4. The registered enrollment target is 74 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Walter Reed National Military Medical Center, which has 48 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 5 interventions - of which Bupivacaine is the first listed.
NCT02947178 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT02947178 about?
NCT02947178 is a clinical study titled "Hip Arthroscopy Pain Control Randomized Control Trial (RCT)". Femoroacetabular impingement is a pathologic process within the hip joint that results from a mechanical discord between the femoral head and neck and the acetabulum that results in chronic hip pain, hip labral tears and early progression of osteoarthritis of the hip.1, 2 Historically an open surgic...
What is the current status of trial NCT02947178?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 74 participants. The study started on 2016-03-01. Estimated completion is 2017-03-01.
What interventions are being tested in trial NCT02947178?
The interventions under investigation include: Bupivacaine (DRUG), Liposomal Bupivacaine (DRUG), Fascial iliac regional soft tissue infiltration blockade (PROCEDURE), Pain Score Survey (BEHAVIORAL), Pill Count (BEHAVIORAL).
Who is sponsoring clinical trial NCT02947178?
This trial is sponsored by Walter Reed National Military Medical Center, which has 48 total clinical trials registered on ClinicalTrials.gov.
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