Clinical trial NCT01997567
Conditions: Internal Derangement of Hip Acetabular Labrum Tear
Keywords: Hip Arthroscopy Regional Anesthesia Peripheral Nerve block
Sponsor: Rush University Medical Center
Start date: 2013-07-01; Completion date: 2014-03-01
Enrollment: 3 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The goal of the study is to evaluate via a prospective, blinded, randomized clinical trial, whether ultrasound-guided single femoral and lateral femoral cutaneous nerve blocks with ropivacaine 0.5% with epinephrine (1:200,000) as a tracer for intravascular injection (total 30 ml) vs. saline with epinephrine (1:200,000) (total 30 ml), given just prior to same day elective hip arthroscopy, is effective in reducing acute postoperative pain (NRS scores), postoperative opiate consumption, and time to discharge from the postanesthesia care unit. Differences between groups with respect to postoperative quality of life and functional scores will also be evaluated.

Detailed description:
The purpose of this study is to evaluate whether ultrasound (using sound waves to produce an image)-guided regional anesthesia (local numbing medicine) to the hip area given in addition to general anesthesia just prior to same day elective hip arthroscopy, is effective in reducing acute postoperative pain, and time to discharge from the post anesthesia care unit. In addition, the study aims to examine whether this regional anesthesia medication has any effect on the study subjects' use of pain medication both during and after the procedure, return to function, and quality of life in the 6 month period after the surgical procedure. Although hip arthroscopy is a routine procedure, the best method for pain control is not well established, and is the purpose of this study.

Arms: arm 1: Group 1 consented subjects will receive for their hip arthroscopy procedures general anesthesia (sevoflurane) with single femoral and lateral femoral cutaneous nerve blocks under ultrasound guidance, with 20 ml solution for the femoral block and 10 ml for lateral femoral cutaneous block, for a total of 30 ml solution of ropivacaine 0.5% with epinephrine 1:200,000 (150mcg) as a tracer for intravascular injection (total 30 ml) arm 2: Group 2 consented subjects will receive for their hip arthroscopy procedures general anesthesia (sevoflurane) with single femoral and lateral femoral cutaneous nerve blocks under ultrasound guidance, with 20 ml solution for the femoral block and 10 ml for lateral femoral cutaneous block, for a total of 30 ml solution of saline with epinephrine 1:200,000 (150 mcg) (total 30 ml)
Interventions: intervention 1: Ropivacaine intervention 2: Placebo
Intervention descriptions: intervention 1: Subjects will receive for their hip arthroscopy procedures general anesthesia (sevoflurane) with single femoral and lateral femoral cutaneous nerve blocks under ultrasound guidance, with 20 ml solution for the femoral block and 10 ml for lateral femoral cutaneous block, for a total of 30 ml solution of ropivacaine 0.5% with epinephrine 1:200,000 (150mcg) as a tracer for intravascular injection (total 30 ml) intervention 2: Group 2 consented subjects will receive for their hip arthroscopy procedures general anesthesia (sevoflurane) with single femoral and lateral femoral cutaneous nerve blocks under ultrasound guidance, with 20 ml solution for the femoral block and 10 ml for lateral femoral cutaneous block, for a total of 30 ml solution of saline with epinephrine 1:200,000 (150 mcg) (total 30 ml)

Protocol documents: