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Ultrasound Guided Supraclavicular Nerve Block

Phase 3
Completed
Conditions
Local Anesthetic
Interventions
Registration Number
NCT00825786
Lead Sponsor
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.

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.

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
103
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

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
Group 1Ropivacainecombined 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;
Group 1Mepivacainecombined 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;
Group 2Ropivacainesequential 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.
Group 2Mepivacainesequential 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.
Primary Outcome Measures
NameTimeMethod
Duration of Analgesia.During surgery: postoperative day 0

The primary outcomes will be the onset time, onset of surgical block, and duration of analgesia.

Secondary Outcome Measures
NameTimeMethod
Time to Complete Motor Blockduring surgery from induction time to end case time
Time to Onset of First Sensory Blockduring surgery
Maximum Verbal Response Score (VRS) With Restthrough 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

Maximum Verbal Response Score (VRS) With Movementthrough 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

Duration of Analgesiafrom surgery date to postoperative day 1

Time from the complete onset of sensory block until first request for an analgesic

Total Opioid Consumptionpostoperative day 1 to day 3

In morphine equivalent dose

Trial Locations

Locations (1)

Cleveland Clinic

🇺🇸

Cleveland, Ohio, United States

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