NCT00967980

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Sep 2009

Shorter than P25 for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 27, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 28, 2009

Completed
4 days until next milestone

Study Start

First participant enrolled

September 1, 2009

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2010

Completed
Last Updated

September 24, 2010

Status Verified

September 1, 2010

Enrollment Period

11 months

First QC Date

August 27, 2009

Last Update Submit

September 23, 2010

Conditions

Hip ArthroplastyHip Pain

Keywords

painHip Resurfacingcatheternerve blockUCSDhip surgerypsoasfemoralambulationhip flexioninfusion

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (7)

  • Analgesic used, as reported by nursing staff in the UCSD computer system.

    3 days following surgery

  • Patient's ambulation distance as recorded by therapist (occupational or physical) in the UCSD computer system.

    3 days following surgery

  • 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

  • Infusion duration of pain pump, measured on the pump itself in hours and minutes.

    3 days following surgery

  • Duration of hospital stay, in hours, as reported in the UCSD computer system.

    3 days following surgery

  • +2 more secondary outcomes

Study Arms (2)

1. Femoral Nerve Block

ACTIVE COMPARATOR

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

2. Psoas Compartment Catheter

ACTIVE COMPARATOR

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

Interventions

Femoral Nerve Block vs. Psoas Compartment Nerve BlockPROCEDURE

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.

1. Femoral Nerve Block2. Psoas Compartment Catheter

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

UCSD Medical Center

San Diego, California, 92103, United States

Location

Related Publications (1)

  • 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.

    PMID: 21467563DERIVED

MeSH Terms

Conditions

Pain

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Brian M Ilfeld, M.D., M.S.

    University of California, San Diego

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

August 27, 2009

First Posted

August 28, 2009

Study Start

September 1, 2009

Primary Completion

August 1, 2010

Study Completion

August 1, 2010

Last Updated

September 24, 2010

Record last verified: 2010-09

Locations

US(1)