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Completed

NCT Number: NCT00825786

Ultrasound Guided Supraclavicular Nerve Block

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.

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Key information

Conditions

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Cleveland Clinic

Cleveland, Ohio, 44195, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Ropivacaine

Drug

ropivacaine (15 ml).

Mepivacaine

Drug

One syringe will contain mepivacaine (15 ml)

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

The Cleveland Clinic

Other

Registry information

Official study title

Ultrasound Guided Supraclavicular Nerve Block: Comparison Between a Mixture of Mepivacaine and Ropivacaine, and Sequential Injection of Mepivacaine Followed by Ropivacaine

Important dates

Study start
2008
Primary completion
2010
Study completion
2010
First posted
Jan 21, 2009
Registry last updated
Jun 14, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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