Preemptive Femoral & Lateral Femoral Cutaneous Nerve Blocks for THA Acute Pain

Rush

Status: Terminated

Conditions: Internal Derangement of Hip; Acetabular Labrum Tear

Treatments: Drug: Ropivacaine; Drug: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT01997567

Hip-Scope-Block

Details and patient eligibility

About

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.

Full 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.

Enrollment: 3 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• >18 year old,
• ASA physical status classification system score (ASA) <=3
• due to undergo elective unilateral hip arthroscopy by one surgeon Dr. Nho (Co-Principal Investigator)

Exclusion criteria

• ASA physical status classification system score) (ASA) >3
• history of opioid dependence or abuse
• current chronic analgesic therapy (daily use =>20 mg oxycodone-equivalent opioid use within 2 weeks before surgery and duration of use >=4 weeks)
• allergy to study medications (fentanyl and ropivicaine)
• any neuromuscular deficit of the ipsilateral femoral nerve or quadriceps femoris muscle (including diabetic peripheral neuropathy)
• diagnosis of hypertension and/or current treatment for hypertension
• pregnancy

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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3 participants in 2 patient groups, including a placebo group

Grp 1 Ropivacaine Block

Active Comparator group

Description:

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)

Treatment:

Drug: Ropivacaine

Grp 2 Placebo Block

Placebo Comparator group

Description:

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)

Treatment:

Drug: Placebo