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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01303120
First Posted: February 24, 2011
Last Update Posted: January 21, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Hillel Yaffe Medical Center
February 20, 2011
February 24, 2011
January 21, 2015
May 2011
December 2013   (Final data collection date for primary outcome measure)
Efficacy of single short femoral nerve block [ Time Frame: Three days ]
Same as current
Complete list of historical versions of study NCT01303120 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
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Does a Single Shot Femoral Nerve Block Alone Produce Appropriate Pain Relief?
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?
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.
Bupivacaine will be used for all the nerve blocks.
Interventional
Not Provided
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Post-operative Pain
  • 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
  • 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
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
107
December 2013
December 2013   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
30 Years to 85 Years   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Israel
 
 
NCT01303120
0021-11-HYMC
Yes
Not Provided
Not Provided
A Stav, MD, Hillel Yaffe Medical Center
Hillel Yaffe Medical Center
Not Provided
Not Provided
Hillel Yaffe Medical Center
February 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP