Ultrasound Guided Supraclavicular Nerve Block

NCT ID: NCT00825786

Last Updated: 2017-06-14

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 103 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-09-30
• Study Completion Date: 2010-08-31

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.

Conditions

Local Anesthetic

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

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;

Group Type: ACTIVE_COMPARATOR

Ropivacaine

Intervention Type: DRUG

ropivacaine (15 ml).

Mepivacaine

Intervention Type: DRUG

One syringe will contain mepivacaine (15 ml)

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.

Group Type: ACTIVE_COMPARATOR

Ropivacaine

Intervention Type: DRUG

ropivacaine (15 ml).

Mepivacaine

Intervention Type: DRUG

One syringe will contain mepivacaine (15 ml)

Interventions

Ropivacaine

ropivacaine (15 ml).

Intervention Type: DRUG

Mepivacaine

One syringe will contain mepivacaine (15 ml)

Intervention Type: DRUG

Eligibility 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

The Cleveland Clinic

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Michael R Ritchey, MD

Role: PRINCIPAL_INVESTIGATOR

Cleveland Clinid

Daniel I Sessler, MD

Role: STUDY_CHAIR

The Cleveland Clinic

Locations

Cleveland Clinic

Cleveland, Ohio, United States

Countries

United States

Other Identifiers

08-671

Identifier Type: -

Identifier Source: org_study_id