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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00967980
Other study ID # Femoral vs. Psoas PNB Cath Hip
Secondary ID
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


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
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