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

Acetabular Labrum Tear Clinical Trial

Official title:

Are Preemptive Femoral and Lateral Femoral Cutaneous Nerve Blocks Given Immediately Prior to Hip Arthroscopy(THA) Effective for Acute Postoperative Pain Management?

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01997567
• Other study ID #: Hip-Scope-Block
• Status: Terminated
• Phase: N/A
• Start date: July 2013
• Est. completion date: March 2014

Study information

• Verified date: September 2018
• Source: Rush University Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Terminated
• Enrollment: 3
• Est. completion date: March 2014
• Est. primary completion date: March 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Acetabular Labrum Tear
• Internal Derangement of Hip

Intervention

Drug:
• Ropivacaine
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)
• Placebo
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)

Locations

Country	Name	City	State
United States	Rush Oak Park Hospital	Oak Park	Illinois

Sponsors (1)

Lead Sponsor	Collaborator
Rush University Medical Center

Country where clinical trial is conducted

United States, 

References & Publications (5)

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. — View 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. — View 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. — View 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. — View 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. Epub 2012 Jul 19. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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	Veterans Research and Development (RAND) 12 Item Health Survey (VR-12) Scores	Preoperative VR-12 scores will be compared with the VR-12 scores obtained at the 3 mo and 6 mo postoperative visits.	Preoperative 2-8 wks
Secondary	Veterans RAND 12 Item Health Survey (VR-12) Scores	Preoperative VR-12 scores will be compared with the VR-12 scores obtained at the 3 mo and 6 mo postoperative visits.	3 months postoperative
Secondary	Veterans RAND 12 Item Health Survey (VR-12) Scores	Preoperative VR-12 scores will be compared with the VR-12 scores obtained at the 3 mo and 6 mo postoperative visits.	6 months postoperative