Does a Single Shot Femoral Nerve Block Alone Produce Appropriate Pain Relief?

The recruitment status of this study is unknown because the information has not been verified recently.

Verified February 2011 by Hillel Yaffe Medical Center.
Recruitment status was Not yet recruiting

Sponsor:

Information provided by:

Hillel Yaffe Medical Center

ClinicalTrials.gov Identifier:

NCT01303120

First received: February 20, 2011

Last updated: February 23, 2011

Last verified: February 2011

History of Changes

Tracking Information
First Received Date ^ICMJE	February 20, 2011
Last Updated Date	February 23, 2011
Start Date ^ICMJE	March 2011
Estimated Primary Completion Date	March 2013 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: February 23, 2011)	Efficacy of single short femoral nerve block [ Time Frame: Three days ] [ Designated as safety issue: No ]
Original Primary Outcome Measures ^ICMJE	Same as current
Change History	Complete list of historical versions of study NCT01303120 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE	Not Provided
Original Secondary Outcome Measures ^ICMJE	Not Provided
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	Does a Single Shot Femoral Nerve Block Alone Produce Appropriate Pain Relief?
Official Title ^ICMJE	Does a Single Shot Femoral Nerve Block Alone Produce Appropriate Pain Relief After Total Knee Arthroplasty or Should an Addition of Sciatic, Obturator and Lateral Femoral Cutaneous Nerve Blocks be Recommended?
Brief Summary	The aim of this study is to compare the efficacy of the analgesic effect of the preoperative femoral nerve block alone versus combined femoral, sciatic, obturator and lateral femoral cutaneous nerve blocks in patients after TKA in the immediate postoperative period.
Detailed Description	Bupivacaine will be used for all the nerve blocks.
Study Type ^ICMJE	Interventional
Study Phase	Not Provided
Study Design ^ICMJE	Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator) Primary Purpose: Treatment
Condition ^ICMJE	Post-operative Pain
Intervention ^ICMJE	Drug: Femoral Nerve Block Preoperative Bupivacaine 0.5%, perineurally as single shot Drug: Combined nerve blocks Preoperative Bupivacaine 0.5%, perineurally as single shot Drug: Patient-controlled analgesia Patient controlled analgesia with morphine
Study Arm (s)	Active Comparator: Femoral Nerve Block Intervention: Drug: Femoral Nerve Block Active Comparator: Combined Nerve Blocks Intervention: Drug: Combined nerve blocks Active Comparator: Patient-controlled analgesia Intervention: Drug: Patient-controlled analgesia
Publications *	Not Provided
* 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	Not yet recruiting
Estimated Enrollment ^ICMJE	90
Estimated Completion Date	March 2013
Estimated Primary Completion Date	March 2013 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	Inclusion Criteria: ASA I-III Undergoing two TKA Understanding PCA protocol Exclusion Criteria: Skin infection near injection site Allergy to local analgesics Peripheral neuropathy Coagulopathy Dementia Proven opioid dependency
Gender	Both
Ages	30 Years to 85 Years
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Not Provided
Location Countries ^ICMJE	Israel

Administrative Information
NCT Number ^ICMJE	NCT01303120
Other Study ID Numbers ^ICMJE	0021-11-HYMC
Has Data Monitoring Committee	Yes
Responsible Party	A Stav, MD, Hillel Yaffe Medical Center
Study Sponsor ^ICMJE	Hillel Yaffe Medical Center
Collaborators ^ICMJE	Not Provided
Investigators ^ICMJE	Not Provided
Information Provided By	Hillel Yaffe Medical Center
Verification Date	February 2011
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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