The Use of Bupivacaine and Ropivacaine for Sciatic Nerve Block

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Antoun Nader, Northwestern University
ClinicalTrials.gov Identifier:
NCT01272921
First received: January 7, 2011
Last updated: September 12, 2014
Last verified: September 2014
  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 for Sciatic Block Following TKR May Vary Between 12-36 Hrs Depending on the Amount of Local Anesthetic Given.
Drug: Bupivacaine
Drug: Ropivacaine
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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 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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
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
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: 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

No publications provided by Northwestern University

Additional 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
Study First Received: January 7, 2011
Results First Received: September 30, 2013
Last Updated: September 12, 2014
Health Authority: United States: Institutional Review Board

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

ClinicalTrials.gov processed this record on October 21, 2014