Clinical trial NCT01997567: Preemptive Femoral & Lateral Femoral Cutaneous Nerve Blocks for THA Acute Pain
Official title: Are Preemptive Femoral and Lateral Femoral Cutaneous Nerve Blocks Given Immediately Prior to Hip Arthroscopy(THA) Effective for Acute Postoperative Pain Management?
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Internal Derangement of Hip
Acetabular Labrum Tear
Keywords: Hip Arthroscopy
Regional Anesthesia
Peripheral Nerve block
Lead sponsor: Rush University Medical Center
Sponsor class: OTHER
First posted: 2013-11-28
Enrollment: 3
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Pain Numerical Rating Scale Score (NRS 0-10)
timeFrame: Preoperative 2-8 wks
measure: Pain Numerical Rating Scale Score (NRS 0-10)
timeFrame: 3 wks postoperative
measure: Pain Numerical Rating Scale Score (NRS 0-10)
timeFrame: 3 months postoperative
measure: Pain Numerical Rating Scale Score (NRS 0-10)
timeFrame: 6 months postoperative
Secondary outcomes:
measure: Veterans Research and Development (RAND) 12 Item Health Survey (VR-12) Scores
timeFrame: Preoperative 2-8 wks
measure: Veterans RAND 12 Item Health Survey (VR-12) Scores
timeFrame: 3 months postoperative
measure: Veterans RAND 12 Item Health Survey (VR-12) Scores
timeFrame: 6 months postoperative
Other outcomes:
Locations:
city: Oak Park
country: United States
facility: Rush Oak Park Hospital
state: Illinois
Study officials:
affiliation: Rush University Medical Center
name: Sandeep Amin, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Rush University Medical Center
name: Shane Nho, M.D., M.S.
role: PRINCIPAL_INVESTIGATOR
References:
citation: YaDeau JT, Tedore T, Goytizolo EA, Kim DH, Green DS, Westrick A, Fan R, Rade MC, Ranawat AS, Coleman SH, Kelly BT. Lumbar plexus blockade reduces pain after hip arthroscopy: a prospective randomized controlled trial. Anesth Analg. 2012 Oct;115(4):968-72. doi: 10.1213/ANE.0b013e318265bacd. Epub 2012 Jul 19.
citation: Ward JP, Albert DB, Altman R, Goldstein RY, Cuff G, Youm T. Are femoral nerve blocks effective for early postoperative pain management after hip arthroscopy? Arthroscopy. 2012 Aug;28(8):1064-9. doi: 10.1016/j.arthro.2012.01.003. Epub 2012 Apr 11.
citation: Lee EM, Murphy KP, Ben-David B. Postoperative analgesia for hip arthroscopy: combined L1 and L2 paravertebral blocks. J Clin Anesth. 2008 Sep;20(6):462-5. doi: 10.1016/j.jclinane.2008.04.012.
citation: Good RP, Snedden MH, Schieber FC, Polachek A. Effects of a preoperative femoral nerve block on pain management and rehabilitation after total knee arthroplasty. Am J Orthop (Belle Mead NJ). 2007 Oct;36(10):554-7.
citation: Aprato A, Jayasekera N, Villar R. Timing in hip arthroscopy: does surgical timing change clinical results? Int Orthop. 2012 Nov;36(11):2231-4. doi: 10.1007/s00264-012-1655-x. Epub 2012 Sep 11.