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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
History of Changes
  Purpose

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.


Condition Intervention Phase
Hip Arthroplasty
Hip Pain
 Procedure: Femoral Nerve Block vs. Psoas Compartment Nerve Block
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Femoral Versus Psoas Continuous Peripheral Nerve Blocks Following Hip Arthroplasty

Further study details as provided by University of California, San Diego:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 50
Study Start Date: September 2009
Study Completion Date: August 2010
Primary Completion Date: August 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
 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: 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.
 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.

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00967980

Locations
United States, California
UCSD Medical Center
San Diego, California, United States, 92103
Sponsors and Collaborators
University of California, San Diego
Investigators
Principal Investigator: Brian M Ilfeld, M.D., M.S. University of California, San Diego
  More Information

No publications provided by University of California, San Diego

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Dr. Brian Ilfeld, University of California, San Diego, Department of Anesthesiology
ClinicalTrials.gov Identifier: NCT00967980     History of Changes
Other Study ID Numbers: Femoral vs. Psoas PNB Cath Hip
Study First Received: August 27, 2009
Last Updated: September 23, 2010
Health Authority: United States: Institutional Review Board

Keywords provided by University of California, San Diego:
pain
Hip Resurfacing
catheter
nerve block
UCSD
hip surgery
 psoas
femoral
ambulation
hip flexion
infusion

ClinicalTrials.gov processed this record on May 16, 2013