Femoral Versus Psoas Continuous Peripheral Nerve Blocks Following Hip Arthroplasty

Hip Arthroplasty Clinical Trial

Official title:

Femoral Versus Psoas Continuous Peripheral Nerve Blocks Following Hip Arthroplasty

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00967980
• Other study ID #: Femoral vs. Psoas PNB Cath Hip
• Status: Completed
• Phase: Phase 4
• First received: August 27, 2009
• Last updated: September 23, 2010
• Start date: September 2009
• Est. completion date: August 2010

Study information

• Verified date: September 2010
• Source: University of California, San Diego
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: August 2010
• Est. primary completion date: August 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hip Arthroplasty
• Hip Pain

Intervention

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.

Locations

Country	Name	City	State
United States	UCSD Medical Center	San Diego	California

Sponsors (1)

Lead Sponsor	Collaborator
University of California, San Diego

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Patient's mean pain score (NRS) during perineural infusion as measured by the nursing staff at UCSD and entered in the computer system.		24 hours beginning 7:30am day following surgery	No
Secondary	Analgesic used, as reported by nursing staff in the UCSD computer system.		3 days following surgery	No
Secondary	Patient's ambulation distance as recorded by therapist (occupational or physical) in the UCSD computer system.		3 days following surgery	No
Secondary	Hip flexion, in degrees measured with a standard goneometer, as recorded by therapist (occupational or physical) in the UCSD computer system.		3 days following surgery	No
Secondary	Infusion duration of pain pump, measured on the pump itself in hours and minutes.		3 days following surgery	No
Secondary	Duration of hospital stay, in hours, as reported in the UCSD computer system.		3 days following surgery	No
Secondary	Surgical/anesthetic adverse events as reported by hospital staff		day of surgery and 3 days following	No
Secondary	Experiences of patient during the infusion and following, as reported to study staff in a phone conversation, one week following surgery.		1 week following surgery	No