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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
  Purpose
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.

Condition Intervention
Post-operative Pain Drug: Femoral Nerve Block Drug: Combined nerve blocks Drug: Patient-controlled analgesia

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: 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?

Further study details as provided by Hillel Yaffe Medical Center:

Primary Outcome Measures:
  • Efficacy of single short femoral nerve block [ Time Frame: Three days ]

Enrollment: 107
Study Start Date: May 2011
Study Completion Date: December 2013
Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Femoral Nerve Block Drug: Femoral Nerve Block
Preoperative Bupivacaine 0.5%, perineurally as single shot
Active Comparator: Combined Nerve Blocks Drug: Combined nerve blocks
Preoperative Bupivacaine 0.5%, perineurally as single shot
Active Comparator: Patient-controlled analgesia Drug: Patient-controlled analgesia
Patient controlled analgesia with morphine

Detailed Description:
Bupivacaine will be used for all the nerve blocks.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   30 Years to 85 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01303120


Locations
Israel
Hillel Yaffe Medical Center
Hadera, Israel, 38100
Sponsors and Collaborators
Hillel Yaffe Medical Center
  More Information

Responsible Party: A Stav, MD, Hillel Yaffe Medical Center
ClinicalTrials.gov Identifier: NCT01303120     History of Changes
Other Study ID Numbers: 0021-11-HYMC
First Submitted: February 20, 2011
First Posted: February 24, 2011
Last Update Posted: January 21, 2015
Last Verified: February 2011

Additional relevant MeSH terms:
Pain, Postoperative
Pain
Neurologic Manifestations
Nervous System Diseases
Postoperative Complications
Pathologic Processes
Signs and Symptoms