Trial Comparing the Onset and Duration of Ultrasound Guided Supraclavicular Nerve Blocks Using Ropivacaine Versus Ropivacaine-Chloroprocaine Mixture
Double Blinded Randomized Control Trial Comparing the Onset and Duration of Ultrasound Guided Supraclavicular Nerve Blocks Using Ropivacaine Versus Ropivacaine-Chloroprocaine Mixture
1 other identifier
interventional
60
1 country
1
Brief Summary
A double blinded randomized controlled trial comparing the onset and duration of the Onset and Duration of Ultrasound Guided Supraclavicular Nerve Blocks Using a long acting local anesthestic (Ropivacaine) with a mixture of a long and short acting local anesthestic (Ropivacaine-Chloroprocaine Mixture).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_4 pain
Started Aug 2009
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2010
CompletedFirst Submitted
Initial submission to the registry
October 29, 2012
CompletedFirst Posted
Study publicly available on registry
November 1, 2012
CompletedResults Posted
Study results publicly available
September 14, 2022
CompletedMay 25, 2023
October 1, 2012
1.3 years
October 29, 2012
August 19, 2022
May 23, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Onset of Surgical Anesthesia
Onset of surgical anesthesia is defined as the time after injection of local anesthetic to the time where no sensation of pinprick in the ulnar, median, radial and musculocutaneous nerves
45 minutes
Secondary Outcomes (1)
Duration of Analgesia
72 hours
Study Arms (2)
Ropivacine and Cholroprocaine mixture
ACTIVE COMPARATOR20 ml's of 1% ropivacaine + 10 ml's of 3% 2-chloroprocaine + 0.1 ml of 1 mg/ml epinephrine
Ropivacine only
SHAM COMPARATOR30 ml syringe with either 20 ml's of 1% ropivacaine + 10 ml's of normal saline + 0.1 ml of 1mg/ml epinephrine
Interventions
Chloroprocaine is added to Ropivacaine
Eligibility Criteria
You may not qualify if:
- patients who are pregnant,
- have an ASA status of IV or greater,
- neuropathy,
- a cast or other impediment to performing a motor or sensory exam in the arm and hand,
- patients under the age of 18,
- long term opioid therapy (longer than 1 month),
- history of opioid abuse and pseudocholinesterase deficiency
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of New Mexicolead
- VA Palo Alto Health Care Systemcollaborator
Study Sites (1)
University of New Mexico
Albuquerque, New Mexico, 87106, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Dr. Nicholas Lam
- Organization
- University of New Mexico
Publication Agreements
- PI is Sponsor Employee
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 29, 2012
First Posted
November 1, 2012
Study Start
August 1, 2009
Primary Completion
November 1, 2010
Study Completion
November 1, 2010
Last Updated
May 25, 2023
Results First Posted
September 14, 2022
Record last verified: 2012-10