Femoral Versus Psoas Continuous Peripheral Nerve Blocks Following Hip Arthroplasty

This study has been completed.
Sponsor:
Information provided by:
University of California, San Diego
ClinicalTrials.gov Identifier:
NCT00967980
First received: August 27, 2009
Last updated: September 23, 2010
Last verified: September 2010

August 27, 2009
September 23, 2010
September 2009
August 2010   (final data collection date for primary outcome measure)
Patient's mean pain score (NRS) during perineural infusion as measured by the nursing staff at UCSD and entered in the computer system. [ Time Frame: 24 hours beginning 7:30am day following surgery ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00967980 on ClinicalTrials.gov Archive Site
  • Analgesic used, as reported by nursing staff in the UCSD computer system. [ Time Frame: 3 days following surgery ] [ Designated as safety issue: No ]
  • Patient's ambulation distance as recorded by therapist (occupational or physical) in the UCSD computer system. [ Time Frame: 3 days following surgery ] [ Designated as safety issue: No ]
  • Hip flexion, in degrees measured with a standard goneometer, as recorded by therapist (occupational or physical) in the UCSD computer system. [ Time Frame: 3 days following surgery ] [ Designated as safety issue: No ]
  • Infusion duration of pain pump, measured on the pump itself in hours and minutes. [ Time Frame: 3 days following surgery ] [ Designated as safety issue: No ]
  • Duration of hospital stay, in hours, as reported in the UCSD computer system. [ Time Frame: 3 days following surgery ] [ Designated as safety issue: No ]
  • Surgical/anesthetic adverse events as reported by hospital staff [ Time Frame: day of surgery and 3 days following ] [ Designated as safety issue: No ]
  • Experiences of patient during the infusion and following, as reported to study staff in a phone conversation, one week following surgery. [ Time Frame: 1 week following surgery ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Femoral Versus Psoas Continuous Peripheral Nerve Blocks Following Hip Arthroplasty
Femoral Versus Psoas Continuous Peripheral Nerve Blocks Following Hip Arthroplasty

The purpose of this research study is to determine if the insertion site of a perineural catheter, or tiny tube placed next to the nerves that go to the hip which you will have surgery, affects the amount of pain relief that is experienced after surgery.

To determine the association between perineural catheter location and postoperative analgesia, analgesic requirements, ambulatory distance, and flexion following hip arthroplasty.

Primary Hypothesis: Differing the catheter insertion site (femoral vs. psoas compartment) for a perineural local anesthetic infusion is not associated with lower pain scores during the 24-hour period beginning the morning following hip arthroplasty.

Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Hip Arthroplasty
  • Hip Pain
Procedure: Femoral Nerve Block vs. Psoas Compartment Nerve Block
Patients, undergoing hip arthroplasty or hip resurfacing will be randomized to one of two groups: femoral nerve block or psoas compartment nerve block. Patients randomized to femoral nerve block will receive this block prior to surgery. Patients randomized to psoas compartment nerve block will receive this block prior to surgery. Both patients will receive Mepivicaine via catheter prior to surgery and following surgery, Ropivicaine via pain pump.
  • Active Comparator: 1. Femoral Nerve Block
    Patients will be randomized with a computer program to receive a femoral catheter. The catheter will be placed using standard technique. The time of catheter placement will be recorded as well as the pain/discomfort of catheter placement as reported by the patient on a 0-10 scale where 0=no pain/discomfort and 10=worst imaginable pain/discomfort.
    Intervention: Procedure: Femoral Nerve Block vs. Psoas Compartment Nerve Block
  • Active Comparator: 2. Psoas Compartment Catheter
    Patients will be randomized with a computer program to receive a psoas compartment catheter. The catheter will be placed using standard technique. The time of catheter placement will be recorded as well as the pain/discomfort of catheter placement as reported by the patient on a 0-10 scale where 0=no pain/discomfort and 10=worst imaginable pain/discomfort.
    Intervention: Procedure: Femoral Nerve Block vs. Psoas Compartment Nerve Block
Ilfeld BM, Mariano ER, Madison SJ, Loland VJ, Sandhu NS, Suresh PJ, Bishop ML, Kim TE, Donohue MC, Kulidjian AA, Ball ST. Continuous femoral versus posterior lumbar plexus nerve blocks for analgesia after hip arthroplasty: a randomized, controlled study. Anesth Analg. 2011 Oct;113(4):897-903. doi: 10.1213/ANE.0b013e318212495b. Epub 2011 Apr 5.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
50
August 2010
August 2010   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • primary, unilateral hip arthroplasty or hip resurfacing
  • age greater than or equal to 18 years
  • postoperative analgesic plan includes perineural local anesthetic infusion

Exclusion Criteria:

  • morbid obesity (BMI greater than 40)
  • chronic, high-dose opioid use
  • history of opioid abuse
  • pregnancy
  • incarceration
  • amu meirp-muscular deficit of the ipsilateral femoral nerve and/or quadriceps muscle
  • inability to communicate with hospital staff
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00967980
Femoral vs. Psoas PNB Cath Hip
No
Dr. Brian Ilfeld, University of California, San Diego, Department of Anesthesiology
University of California, San Diego
Not Provided
Principal Investigator: Brian M Ilfeld, M.D., M.S. University of California, San Diego
University of California, San Diego
September 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP