Femoral Versus Psoas Continuous Peripheral Nerve Blocks Following Hip Arthroplasty

Tracking Information
First Submitted Date ICMJE	August 27, 2009
First Posted Date ICMJE	August 28, 2009
Last Update Posted Date	September 24, 2010
Study Start Date ICMJE	September 2009
Actual Primary Completion Date	August 2010 (Final data collection date for primary outcome measure)
Current Primary Outcome Measures ICMJE; (submitted: August 27, 2009)	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 ]
Original Primary Outcome Measures ICMJE	Same as current
Change History	Complete list of historical versions of study NCT00967980 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ICMJE; (submitted: August 27, 2009)	Analgesic used, as reported by nursing staff in the UCSD computer system. [ Time Frame: 3 days following surgery ]; Patient's ambulation distance as recorded by therapist (occupational or physical) in the UCSD computer system. [ Time Frame: 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. [ Time Frame: 3 days following surgery ]; Infusion duration of pain pump, measured on the pump itself in hours and minutes. [ Time Frame: 3 days following surgery ]; Duration of hospital stay, in hours, as reported in the UCSD computer system. [ Time Frame: 3 days following surgery ]; Surgical/anesthetic adverse events as reported by hospital staff [ Time Frame: 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. [ Time Frame: 1 week following surgery ]
Original Secondary Outcome Measures ICMJE	Same as current
Current Other Outcome Measures ICMJE	Not Provided
Original Other Outcome Measures ICMJE	Not Provided
Descriptive Information
Brief Title ICMJE	Femoral Versus Psoas Continuous Peripheral Nerve Blocks Following Hip Arthroplasty
Official Title ICMJE	Femoral Versus Psoas Continuous Peripheral Nerve Blocks Following Hip Arthroplasty
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.
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 ICMJE	Interventional
Study Phase	Phase 4
Study Design ICMJE	Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Treatment
Condition ICMJE	Hip Arthroplasty; Hip Pain
Intervention ICMJE	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.
Study Arms	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. Intervention: Procedure: Femoral Nerve Block vs. Psoas Compartment Nerve Block; 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. Intervention: Procedure: Femoral Nerve Block vs. Psoas Compartment Nerve Block
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.
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status ICMJE	Completed
Estimated Enrollment ICMJE; (submitted: January 13, 2010)	50
Original Estimated Enrollment ICMJE; (submitted: August 27, 2009)	80
Actual Study Completion Date	August 2010
Actual Primary Completion Date	August 2010 (Final data collection date for primary outcome measure)
Eligibility Criteria ICMJE	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
Sex/Gender	Sexes Eligible for Study: All
Ages	18 Years and older (Adult, Senior)
Accepts Healthy Volunteers	No
Contacts ICMJE	Contact information is only displayed when the study is recruiting subjects
Listed Location Countries ICMJE	United States
Removed Location Countries
Administrative Information
NCT Number ICMJE	NCT00967980
Other Study ID Numbers ICMJE	Femoral vs. Psoas PNB Cath Hip
Has Data Monitoring Committee	No
U.S. FDA-regulated Product	Not Provided
IPD Sharing Statement	Not Provided
Responsible Party	Dr. Brian Ilfeld, University of California, San Diego, Department of Anesthesiology
Study Sponsor ICMJE	University of California, San Diego
Collaborators ICMJE	Not Provided
Investigators ICMJE	Principal Investigator: Brian M Ilfeld, M.D., M.S. University of California, San Diego
PRS Account	University of California, San Diego
Verification Date	September 2010
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP