Femoral Versus Psoas Continuous Peripheral Nerve Blocks Following Hip Arthroplasty
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ClinicalTrials.gov Identifier: NCT00967980 |
Recruitment Status
:
Completed
First Posted
: August 28, 2009
Last Update Posted
: September 24, 2010
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Sponsor:
University of California, San Diego
Information provided by:
University of California, San Diego
Tracking Information | ||||
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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 |
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 |
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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. |
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Study Type ICMJE | Interventional | |||
Study Phase | Phase 4 | |||
Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: None (Open Label) Primary Purpose: Treatment |
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Condition ICMJE |
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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. |
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Study Arms |
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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. |
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Recruitment Information | ||||
Recruitment Status ICMJE | Completed | |||
Estimated Enrollment ICMJE |
50 | |||
Original Estimated Enrollment ICMJE |
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:
Exclusion Criteria:
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Sex/Gender |
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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 |
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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 |