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

Not Applicable
Terminated
Conditions
Acetabular Labrum Tear
Internal Derangement of Hip
Interventions
Drug: Placebo
Registration Number
NCT01997567
Lead Sponsor
Rush University Medical Center
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.

Recruitment & Eligibility

Status
TERMINATED
Sex
All
Target Recruitment
3
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

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
Grp 1 Ropivacaine BlockRopivacaineGroup 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)
Grp 2 Placebo BlockPlaceboGroup 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)
Primary Outcome Measures
NameTimeMethod
Pain Numerical Rating Scale Score (NRS 0-10)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 Outcome Measures
NameTimeMethod
Veterans Research and Development (RAND) 12 Item Health Survey (VR-12) ScoresPreoperative 2-8 wks

Preoperative VR-12 scores will be compared with the VR-12 scores obtained at the 3 mo and 6 mo postoperative visits.

Veterans RAND 12 Item Health Survey (VR-12) Scores6 months postoperative

Preoperative VR-12 scores will be compared with the VR-12 scores obtained at the 3 mo and 6 mo postoperative visits.

Trial Locations

Locations (1)

Rush Oak Park Hospital

🇺🇸

Oak Park, Illinois, United States

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