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
  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: Double Blind (Subject, Caregiver, 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 ] [ Designated as safety issue: No ]

Estimated Enrollment: 90
Study Start Date: March 2011
Estimated Study Completion Date: March 2013
Estimated Primary Completion Date: March 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

Ages Eligible for Study:   30 Years to 85 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01303120

Locations
Israel
Hillel Yaffe Medical Center Not yet recruiting
Hadera, Israel, 38100
Contact: Anatoly Stav, MD       stav@hy.health.gov.il   
Sponsors and Collaborators
Hillel Yaffe Medical Center
  More Information

No publications provided

Responsible Party: A Stav, MD, Hillel Yaffe Medical Center
ClinicalTrials.gov Identifier: NCT01303120     History of Changes
Other Study ID Numbers: 0021-11-HYMC
Study First Received: February 20, 2011
Last Updated: February 23, 2011
Health Authority: Israel: Ministry of Health

Additional relevant MeSH terms:
Pain, Postoperative
Pain
Pathologic Processes
Postoperative Complications
Signs and Symptoms

ClinicalTrials.gov processed this record on October 21, 2014