Ultrasound Guided Supraclavicular Nerve Block

This study has been completed.
Sponsor:
Information provided by:
Outcomes Research Consortium
ClinicalTrials.gov Identifier:
NCT00825786
First received: January 16, 2009
Last updated: September 6, 2011
Last verified: August 2011

January 16, 2009
September 6, 2011
September 2008
August 2010   (final data collection date for primary outcome measure)
  • duration of analgesia. [ Time Frame: During surgery ] [ Designated as safety issue: No ]
    The primary outcomes will be the onset time, onset of surgical block, and duration of analgesia.
  • Onset time of surgical block [ Time Frame: during surgery ] [ Designated as safety issue: No ]
    The primary outcomes will be the onset time, onset of surgical block, and duration of analgesia.
  • Onset time of surgical block [ Time Frame: through post operative day 3 ] [ Designated as safety issue: No ]
    The primary outcomes will be the onset time, onset of surgical block, and duration of analgesia.
  • duration of analgesia [ Time Frame: through post operative day 3 ] [ Designated as safety issue: No ]
    The primary outcomes will be the onset time, onset of surgical block, and duration of analgesia.
The primary outcomes will be the onset time, onset of surgical block, and duration of analgesia. [ Time Frame: During surgery, Post op through day 3 ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00825786 on ClinicalTrials.gov Archive Site
  • time to a significant increase in discomfort [ Time Frame: Post op through day 3 ] [ Designated as safety issue: No ]
    Secondary outcomes will be: time to a significant increase in discomfort, time to a noticeable decrease in numbness and / or weakness, maximum verbal response score (VRS) with rest and movement, and total opioid consumption.
  • time to a noticeable decrease in numbness and/or weakness [ Time Frame: through post operative day 3 ] [ Designated as safety issue: No ]
    Secondary outcomes will be: time to a significant increase in discomfort, time to a noticeable decrease in numbness and / or weakness, maximum verbal response score (VRS) with rest and movement, and total opioid consumption
  • maximum verbal response score (VRS) with rest [ Time Frame: through post operative day 3 ] [ Designated as safety issue: No ]
    Secondary outcomes will be: time to a significant increase in discomfort, time to a noticeable decrease in numbness and / or weakness, maximum verbal response score (VRS) with rest and movement, and total opioid consumption.
  • maximum verbal response score (VRS) with movement [ Time Frame: through post operative day 3 ] [ Designated as safety issue: No ]
    Secondary outcomes will be: time to a significant increase in discomfort, time to a noticeable decrease in numbness and / or weakness, maximum verbal response score (VRS) with rest and movement, and total opioid consumption.
  • total opioid consumption [ Time Frame: through post operative day 3 ] [ Designated as safety issue: No ]
    Secondary outcomes will be: time to a significant increase in discomfort, time to a noticeable decrease in numbness and / or weakness, maximum verbal response score (VRS) with rest and movement, and total opioid consumption.
Secondary outcomes will be: time to a significant increase in discomfort, time to a noticeable decrease in numbness and / or weakness, maximum verbal response score (VRS) with rest and movement, and total opioid consumption. [ Time Frame: Post op through day 3 ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
Ultrasound Guided Supraclavicular Nerve Block
Ultrasound Guided Supraclavicular Nerve Block: Comparison Between a Mixture of Mepivacaine and Ropivacaine, and Sequential Injection of Mepivacaine Followed by Ropivacaine

This study will test the hypothesis that sequential injection of 1.5% mepivacaine followed 90 seconds later by 0.5% ropivacaine in ultrasound guided supraclavicular block provides a quicker onset and a longer duration of analgesia than an equi-dose mixture of the two local anesthetics.

Patients will be randomized into one of two groups, Group M: Ropivacaine and Mepivacaine - subject will receive two injections before surgery begins. These two injections will consist of the mixture of mepivacaine (15 ml) and ropivacaine (15 ml).

Group S: Mepivacaine followed by Ropivacaine. Subjects will receive two injections before surgery begins. One injection will contain mepivacaine (15 ml) and the other will contain ropivacaine (15 ml).

On the first, second, and third mornings after surgery,subjects will be asked to rate their pain on a scale of 1 to 10. If the subject is discharged from the hospital, a telephone call will be made to the subject's home to collect this information.

Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Local Anesthetic
  • Drug: Ropivacaine
    mepivacaine (15 ml) and ropivacaine (15 ml).
  • Drug: Mepivacaine and ropivacaine
    One syringe will contain mepivacaine (15 ml) and the other will contain ropivacaine (15 ml).
  • Active Comparator: Group 1

    One injection with two syringes before surgery begins. These two syringes will consist of the mixture of mepivacaine (15 ml) and ropivacaine (15 ml).

    1:1 volume mixture of 1.5% mepivacaine and 0.5% ropivacaine in two syringes (labeled no. 1 and no. 2) with 15 ml in each (Total: 30 ml).

    Interventions:
    • Drug: Ropivacaine
    • Drug: Mepivacaine and ropivacaine
  • Active Comparator: Group 2

    One injection with two syringes before your surgery begins.One syringe will contain mepivacaine (15 ml) and the other will contain ropivacaine (15 ml).

    Syringe no. 1 containing 15 ml of 1.5% mepivacaine. Syringe no. 2 containing 15 ml of 0.5% ropivacaine (Total: 30 ml).

    Intervention: Drug: Mepivacaine and ropivacaine
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
120
August 2010
August 2010   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Patients undergoing upper extremity procedures suitable for supraclavicular anesthesia, including but not limited to oHand surgery oForearm surgery oElbow surgery
  • Age between 18 and 70 years

Exclusion Criteria:

  • Contraindications to supraclavicular block

    • Coagulopathy
    • Infection at the needle insertion site
    • Severe chronic obstructive pulmonary disease (COPD)
    • Contralateral pneumothorax or diaphragmatic paralysis
  • Pregnancy
  • Preexisting neuropathy involving the surgical limb
  • Routine opioid use
  • Inability to attain adequate ultrasound images in the supraclavicular area
Both
18 Years to 70 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00825786
08-671
No
Micheal Ritchey, M.D., Cleveland Clinic
Outcomes Research Consortium
Not Provided
Principal Investigator: Michael R Ritchey, MD Cleveland Clinid
Study Chair: Daniel I Sessler, MD The Cleveland Clinic
Outcomes Research Consortium
August 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP