Ultrasound Guided Supraclavicular Nerve Block

Local Anesthetic Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00825786
• Other study ID #: 08-671
• Status: Completed
• Phase: Phase 3
• First received: January 16, 2009
• Last updated: April 18, 2017
• Start date: September 2008
• Est. completion date: August 2010

Study information

• Verified date: April 2017
• Source: The Cleveland Clinic
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 120
• Est. completion date: August 2010
• Est. primary completion date: August 2010
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Local Anesthetic

Intervention

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

Locations

Country	Name	City	State
United States	Cleveland Clinic	Cleveland	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
The Cleveland Clinic

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	duration of analgesia.	The primary outcomes will be the onset time, onset of surgical block, and duration of analgesia.	During surgery
Primary	Onset time of surgical block	The primary outcomes will be the onset time, onset of surgical block, and duration of analgesia.	during surgery
Primary	Onset time of surgical block	The primary outcomes will be the onset time, onset of surgical block, and duration of analgesia.	through post operative day 3
Primary	duration of analgesia	The primary outcomes will be the onset time, onset of surgical block, and duration of analgesia.	through post operative day 3
Secondary	time to a significant increase in discomfort	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.	Post op through day 3
Secondary	time to a noticeable decrease in numbness and/or weakness	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	through post operative day 3
Secondary	maximum verbal response score (VRS) with rest	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.	through post operative day 3
Secondary	maximum verbal response score (VRS) with movement	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.	through post operative day 3
Secondary	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.	through post operative day 3