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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
History of Changes
  Purpose

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.


Condition Intervention Phase
Local Anesthetic
 Drug: Ropivacaine
Drug: Mepivacaine and ropivacaine
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Ultrasound Guided Supraclavicular Nerve Block: Comparison Between a Mixture of Mepivacaine and Ropivacaine, and Sequential Injection of Mepivacaine Followed by Ropivacaine

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Outcomes Research Consortium:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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.


Enrollment: 120
Study Start Date: September 2008
Study Completion Date: August 2010
Primary Completion Date: August 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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).

 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 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).

 Drug: Mepivacaine and ropivacaine
One syringe will contain mepivacaine (15 ml) and the other will contain ropivacaine (15 ml).

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00825786

Locations
United States, Ohio
Cleveland Clinic
Cleveland, Ohio, United States, 44195
Sponsors and Collaborators
Outcomes Research Consortium
Investigators
Principal Investigator: Michael R Ritchey, MD Cleveland Clinid
Study Chair: Daniel I Sessler, MD The Cleveland Clinic
  More Information

No publications provided

Responsible Party: Micheal Ritchey, M.D., Cleveland Clinic
ClinicalTrials.gov Identifier: NCT00825786     History of Changes
Other Study ID Numbers: 08-671
Study First Received: January 16, 2009
Last Updated: September 6, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by Outcomes Research Consortium:
surgery for arm hand or elbow
mepivacaine
ropivacaine
 hand surgery
elbow surgery
forearm surgery

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

ClinicalTrials.gov processed this record on May 23, 2013