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

NCT01997567 | Terminated Results

• 1 other identifier: Hip-Scope-Block
• Study Type: interventional
• Target: 3
• Locations: 1 country
• Sites: 1

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.

Conditions

Internal Derangement of Hip; Acetabular Labrum Tear

Keywords

Hip Arthroscopy; Regional Anesthesia; Peripheral Nerve block

Outcome Measures

Primary Outcomes (4)

• Pain Numerical Rating Scale Score (NRS 0-10)

  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.

  Preoperative 2-8 wks

• Pain Numerical Rating Scale Score (NRS 0-10)

  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. Study was closed due to enrollment issues and data were not collected or analized.

  3 wks postoperative

• Pain Numerical Rating Scale Score (NRS 0-10)

  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.

  3 months postoperative

• Pain Numerical Rating Scale Score (NRS 0-10)

  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.

  6 months postoperative

Secondary Outcomes (3)

• 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

  3 months postoperative

• Veterans RAND 12 Item Health Survey (VR-12) Scores

  6 months postoperative

Study Arms (2)

Grp 1 Ropivacaine Block

ACTIVE COMPARATOR

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)

Drug: Ropivacaine

Grp 2 Placebo Block

PLACEBO COMPARATOR

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)

Drug: Placebo

Interventions

Ropivacaine DRUG

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 1 Ropivacaine Block

Placebo DRUG

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)

Grp 2 Placebo Block

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \>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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Rush University Medical Center: lead

Study Sites (1)

Rush Oak Park Hospital

Oak Park, Illinois, 60304, United States

Location

Related Publications (5)

• 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.

  PMID: 22822195 BACKGROUND

• 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.

  PMID: 22498045 BACKGROUND

• 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.

  PMID: 18929290 BACKGROUND

• 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.

  PMID: 18033568 BACKGROUND

• 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.

  PMID: 22965491 BACKGROUND

MeSH Terms

Interventions

Ropivacaine

Intervention Hierarchy (Ancestors)

Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Results Point of Contact

• Title: Sandeep Amin, M.D
• Organization: Rush University Medical Center Department of Anesthesiology

Sandeep_Amin@rush.edu

312-942-6449

Study Officials

• Sandeep Amin, M.D.

  Rush University Medical Center

  PRINCIPAL INVESTIGATOR

• Shane Nho, M.D., M.S.

  Rush University Medical Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor, Attending Anesthesiologist

Study Record Dates

• First Submitted: June 13, 2013
• First Posted: November 28, 2013
• Study Start: July 1, 2013
• Primary Completion: March 1, 2014
• Study Completion: March 1, 2014
• Last Updated: October 3, 2018
• Results First Posted: June 17, 2016

Record last verified: 2018-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)