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.

Study Overview

• Status: Completed
• Conditions: Hip Arthroplasty; Hip Pain
• Intervention / Treatment: Procedure: Femoral Nerve Block vs. Psoas Compartment Nerve Block

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.

• Study Type: Interventional
• Enrollment (Anticipated): 50
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • California
    • San Diego, California, United States, 92103
      • UCSD Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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 Outcome Measures

Outcome Measure	Time Frame
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
Surgical/anesthetic adverse events as reported by hospital staff	day of surgery and 3 days following
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

Collaborators and Investigators

• Sponsor: University of California, San Diego

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: September 1, 2009
• Primary Completion (Actual): August 1, 2010
• Study Completion (Actual): August 1, 2010

Study Registration Dates

• First Submitted: August 27, 2009
• First Submitted That Met QC Criteria: August 27, 2009
• First Posted (Estimate): August 28, 2009

Study Record Updates

• Last Update Posted (Estimate): September 24, 2010
• Last Update Submitted That Met QC Criteria: September 23, 2010
• Last Verified: September 1, 2010

More Information

Terms related to this study

• Keywords: pain; nerve block; Hip Resurfacing; infusion; femoral; ambulation; hip surgery; catheter; UCSD; psoas; hip flexion
• Other Study ID Numbers: Femoral vs. Psoas PNB Cath Hip