The Use of Bupivacaine and Ropivacaine for Sciatic Nerve Block
A Dose Response Study for Duration of Analgesia Using Bupivacaine and Ropivacaine for Infragluteal Parabiceps Sciatic Block
1 other identifier
interventional
142
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_4
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 2010
CompletedFirst Submitted
Initial submission to the registry
January 7, 2011
CompletedFirst Posted
Study publicly available on registry
January 10, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2012
CompletedResults Posted
Study results publicly available
March 21, 2014
CompletedApril 6, 2017
March 1, 2017
1.8 years
January 7, 2011
September 30, 2013
March 8, 2017
Conditions
Outcome Measures
Primary Outcomes (1)
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
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).
3 days
Secondary Outcomes (1)
Cumulative Probabilities for Needle Positioning Above and Below CIEL.
1 Day
Study Arms (2)
Bupivacaine
ACTIVE COMPARATORVarying does to determine duration of analgesia following a sciatic nerve block
Ropivacaine
ACTIVE COMPARATORVarying does to determine duration of analgesia following a sciatic nerve block
Interventions
Eligibility Criteria
You may qualify if:
- Adult patients (\>18 years of age) who are undergoing elective total knee arthroplasty will be included in the study.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Northwestern University, Feingberg School of Medicine
Chicago, Illinois, 60611, United States
Related Publications (1)
Nader A, Kendall MC, De Oliveira GS Jr, Puri L, Tureanu L, Brodskaia A, Asher Y, Parimi V, McCarthy RJ. A dose-ranging study of 0.5% bupivacaine or ropivacaine on the success and duration of the ultrasound-guided, nerve-stimulator-assisted sciatic nerve block: a double-blind, randomized clinical trial. Reg Anesth Pain Med. 2013 Nov-Dec;38(6):492-502. doi: 10.1097/AAP.0b013e3182a4bddf.
PMID: 24108248DERIVED
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Limitations and Caveats
We used 5-mL increments of local anesthetic w/epinephrine between 5-30 mL which may have prevented from identifying more precisely the volume at which onset/duration were similar.
Results Point of Contact
- Title
- Mark Kendall, M.D.
- Organization
- Northwestern University
Study Officials
- PRINCIPAL INVESTIGATOR
Antoun Nader, MD
Northwestern University Feinberg School of Medicine
Publication Agreements
- PI is Sponsor Employee
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, OUTCOMES ASSESSOR
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor in Anesthesiology and Orthopaedic Surgery
Study Record Dates
First Submitted
January 7, 2011
First Posted
January 10, 2011
Study Start
November 1, 2010
Primary Completion
August 1, 2012
Last Updated
April 6, 2017
Results First Posted
March 21, 2014
Record last verified: 2017-03