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The Use of Bupivacaine and Ropivacaine for Sciatic Nerve Block

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01272921
First Posted: January 10, 2011
Last Update Posted: April 6, 2017
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 (Responsible Party):
Antoun Nader, Northwestern University
  Purpose
The duration of motor block for infragluteal parabiceps sciatic nerve block following total knee replacement may vary between 12-36 hrs depending on the amount of local anesthetic given.

Condition Intervention Phase
The Duration of Motor Block May Vary Between 12-36 Hrs Drug: Bupivacaine Drug: Ropivacaine Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Supportive Care
Official Title: A Dose Response Study for Duration of Analgesia Using Bupivacaine and Ropivacaine for Infragluteal Parabiceps Sciatic Block

Resource links provided by NLM:


Further study details as provided by Antoun Nader, Northwestern University:

Primary Outcome Measures:
  • Duration of Motor and Sensory Block of the Sciatic With 0.5% Bupivacaine and Ropivacaine After Ultrasound-guided Nerve-stimulator-Assisted Needle Positioning Beneath the CIEL [ Time Frame: 3 days ]
    Subject reported and investigator measured motor and sensory blockade of the sciatic nerve with less than 10ml of 0.5% bupivacaine and ropivacaine after ultrasound-guided nerve-stimulator-assisted needle positioning beneath the common investing external layer (CIEL).


Secondary Outcome Measures:
  • Cumulative Probabilities for Needle Positioning Above and Below CIEL. [ Time Frame: 1 Day ]
    The cumulative probability distributions for the minimal current to evoke a motor response with the needle tip positioned external (above) to the common investing extraneural layer (CIEL) and the cumulative probability distribution for the needle tip postioned internal (below) to the CIEL were sought. The difference in the mean minimum threshold current (mA) for the external (above) and internal (below) CIEL positioning were calculated.


Enrollment: 142
Study Start Date: November 2010
Primary Completion Date: August 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Bupivacaine
Varying does to determine duration of analgesia following a sciatic nerve block
Drug: Bupivacaine
Varying doses to determine the duration of analgesia
Active Comparator: Ropivacaine
Varying does to determine duration of analgesia following a sciatic nerve block
Drug: Ropivacaine
Varying doses to determine the duration of analgesia

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Adult patients (>18 years of age) who are undergoing elective total knee arthroplasty will be included in the study.

Exclusion Criteria:

  • Exclusion criteria for the study are patient refusal to be included in the study, contraindications to regional anesthesia, history of allergy to amide local anesthetics, the presence of a progressive neurological deficit, the presence of coagulopathy or infection, or pregnancy
  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): NCT01272921


Locations
United States, Illinois
Northwestern University, Feingberg School of Medicine
Chicago, Illinois, United States, 60611
Sponsors and Collaborators
Northwestern University
Investigators
Principal Investigator: Antoun Nader, MD Northwestern University Feinberg School of Medicine
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Antoun Nader, Professor in Anesthesiology and Orthopaedic Surgery, Northwestern University
ClinicalTrials.gov Identifier: NCT01272921     History of Changes
Other Study ID Numbers: STU00035380
First Submitted: January 7, 2011
First Posted: January 10, 2011
Results First Submitted: September 30, 2013
Results First Posted: March 21, 2014
Last Update Posted: April 6, 2017
Last Verified: March 2017

Additional relevant MeSH terms:
Bupivacaine
Ropivacaine
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents


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