Hip Arthroscopy Pain Control Randomized Control Trial (RCT)

Completed · Phase 4

Conditions studied: Hip Pain Chronic, Anesthesia, Bupivacaine

In brief

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.

Key facts

Study ID

NCT02947178

Run by

Walter Reed National Military Medical Center

People needed

74

Starts

2016-03-01

Expected to finish

2017-03-01

Last updated by the study team

2018-01-10

Who can join

Age: 18 and older, up to 50. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Patient is scheduled to undergo hip arthroscopy
• Patient is between 18-50 years of age
• DEERS eligibility

You may not qualify if…

• Patients who are on a medication pre-operatively that would prohibit them from receiving one of the study medications
• Patient is unable to speak/read the English language (Currently, the DVPRS has only been scientifically validated in the English language and translating to languages other than English would compromise the validity of the pain scale)
• Patient has a history of previous hip arthroscopy surgery
• The patient is pregnant - ruled out with routine urine pregnancy test the morning of surgery in the anesthesia pre-operative unit.
• The patient carries a pre-existing diagnosis of a pain disorder. (Example: Fibromyalgia)
• The patient has a previous history of narcotic pain medication abuse.
• The patient has an allergy to one of the study medications

Where it is running

• Walter Reed National Military Medical Center — Bethesda, Maryland, United States

Full record on ClinicalTrials.gov

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