Are Preemptive Femoral and Lateral Femoral Cutaneous Nerve Blocks Given Immediately Prior to Hip Arthroscopy(THA) Effective for Acute Postoperative Pain Management?
Overview
- Phase
- Not Applicable
- Intervention
- Ropivacaine
- Conditions
- Internal Derangement of Hip
- Sponsor
- Rush University Medical Center
- Enrollment
- 3
- Locations
- 1
- Primary Endpoint
- Pain Numerical Rating Scale Score (NRS 0-10)
- Status
- Terminated
- Last Updated
- 7 years ago
Overview
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.
Investigators
Sandeep Amin, MD
Assistant Professor, Attending Anesthesiologist
Rush University Medical Center
Eligibility Criteria
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
Arms & Interventions
Grp 1 Ropivacaine Block
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)
Intervention: Ropivacaine
Grp 2 Placebo Block
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)
Intervention: Placebo
Outcomes
Primary Outcomes
Pain Numerical Rating Scale Score (NRS 0-10)
Time Frame: 6 months postoperative
The primary outcome measure will be pain scores at rest (NRS 0-10). Those scores will be documented at initial visit prior to surgery, and at postoperative office visits at 3 weeks, 3 months and 6 months post-procedure.
Secondary Outcomes
- Veterans Research and Development (RAND) 12 Item Health Survey (VR-12) Scores(Preoperative 2-8 wks)
- Veterans RAND 12 Item Health Survey (VR-12) Scores(6 months postoperative)