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Ultrasound Guided Supraclavicular Nerve Block

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00825786
Recruitment Status : Completed
First Posted : January 21, 2009
Results First Posted : April 19, 2017
Last Update Posted : June 14, 2017
Sponsor:
Information provided by (Responsible Party):
The Cleveland Clinic

Brief Summary:
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 or disease Intervention/treatment Phase
Local Anesthetic Drug: Ropivacaine Drug: Mepivacaine Phase 3

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 103 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (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
Study Start Date : September 2008
Actual Primary Completion Date : August 2010
Actual Study Completion Date : August 2010

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Group 1
combined group: ropivacaine and mepivacaine mixture: 1:1 volume mixture of 1.5% mepivacaine and 0.5% ropivacaine in 2 syringes (labeled 1 and 2) with 15 mL in each (total, 30 mL) injected in immediate sequence;
Drug: Ropivacaine
ropivacaine (15 ml).

Drug: Mepivacaine
One syringe will contain mepivacaine (15 ml)

Active Comparator: Group 2
sequential group: mepivacaine followed by ropivacaine: syringe 1 containing 15 mL of 1.5% mepivacaine, syringe 2 containing 15 mL of 0.5% ropivacaine (total, 30 mL); syringe 2 was injected with a 90-sec delay after injection of syringe 1.
Drug: Ropivacaine
ropivacaine (15 ml).

Drug: Mepivacaine
One syringe will contain mepivacaine (15 ml)




Primary Outcome Measures :
  1. Duration of Analgesia. [ Time Frame: During surgery: postoperative day 0 ]
    The primary outcomes will be the onset time, onset of surgical block, and duration of analgesia.


Secondary Outcome Measures :
  1. Time to Complete Motor Block [ Time Frame: during surgery from induction time to end case time ]
  2. Time to Onset of First Sensory Block [ Time Frame: during surgery ]
  3. Maximum Verbal Response Score (VRS) With Rest [ Time Frame: through post operative day 3 ]
    The severity of postoperative pain was assessed by an observer blinded to treatment using a 0- to 10-point verbal response score (VRS): 0 = no pain and 10= worst pain

  4. Maximum Verbal Response Score (VRS) With Movement [ Time Frame: through post operative day 3 ]
    The severity of postoperative pain was assessed by an observer blinded to treatment using a 0- to 10-point verbal response score (VRS): 0 = no pain and 10 = worst

  5. Duration of Analgesia [ Time Frame: from surgery date to postoperative day 1 ]
    Time from the complete onset of sensory block until first request for an analgesic

  6. Total Opioid Consumption [ Time Frame: postoperative day 1 to day 3 ]
    In morphine equivalent dose



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00825786


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

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Responsible Party: The Cleveland Clinic
ClinicalTrials.gov Identifier: NCT00825786    
Other Study ID Numbers: 08-671
First Posted: January 21, 2009    Key Record Dates
Results First Posted: April 19, 2017
Last Update Posted: June 14, 2017
Last Verified: May 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by The Cleveland Clinic:
surgery for arm hand or elbow
mepivacaine
ropivacaine
hand surgery
elbow surgery
forearm surgery
Additional relevant MeSH terms:
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Ropivacaine
Mepivacaine
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents