Ultrasound Guided Supraclavicular Nerve Block - Full Text View

Sponsored by:	Outcomes Research Consortium
Information provided by:	Outcomes Research Consortium
ClinicalTrials.gov Identifier:	NCT00825786

Purpose

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	Intervention	Phase
Hand Surgery Elbow Surgery Forearm Surgery	Drug: Ropivacaine Drug: Mepivacaine	Phase III

MedlinePlus related topics: Anesthesia Surgery Ultrasound

Drug Information available for: Ropivacaine Mepivacaine Ropivacaine monohydrochloride Ropivacaine Hydrochloride Mepivacaine hydrochloride

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Single Blind (Outcomes Assessor), Active Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	Ultrasound Guided Supraclavicular Nerve Block: Comparison Between a Mixture of Mepivacaine and Ropivacaine, and Sequential Injection of Mepivacaine Followed by Ropivacaine

Further study details as provided by Outcomes Research Consortium:

Primary Outcome Measures:

The primary outcomes will be the onset time, onset of surgical block, and duration of analgesia. [ Time Frame: During surgery, Post op through day 3 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

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. [ Time Frame: Post op through day 3 ] [ Designated as safety issue: No ]

Estimated Enrollment:	120
Study Start Date:	September 2008
Estimated Study Completion Date:	September 2009
Estimated Primary Completion Date:	September 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Group 1: Active Comparator One injection with two syringes before surgery begins. These two syringes will consist of the mixture of mepivacaine (15 ml) and ropivacaine (15 ml). 1:1 volume mixture of 1.5% mepivacaine and 0.5% ropivacaine in two syringes (labeled no. 1 and no. 2) with 15 ml in each (Total: 30 ml).	Drug: Ropivacaine Drug: Mepivacaine
Group 2: Active Comparator One injection with two syringes before your surgery begins.One syringe will contain mepivacaine (15 ml) and the other will contain ropivacaine (15 ml). Syringe no. 1 containing 15 ml of 1.5% mepivacaine. Syringe no. 2 containing 15 ml of 0.5% ropivacaine (Total: 30 ml).	Drug: Ropivacaine Drug: Mepivacaine

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.

Eligibility

Ages Eligible for Study:	18 Years to 70 Years
Genders Eligible for Study:	Both
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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00825786

Contacts

Contact: Priya Kumar, MD	216-444-4411	kumarp2@ccf.org
Contact: Nancy Graham, BA,CCRP	216-445-7530	grahamn@ccf.org

Locations

United States, Ohio
Cleveland Clinic	Recruiting
Cleveland, Ohio, United States, 44195
Principal Investigator: Priyia Kumar, MD

Sponsors and Collaborators

Outcomes Research Consortium

Investigators

Principal Investigator:	Priya Kumar, MD	Cleveland Clinid
Study Chair:	Daniel I Sessler, MD	Cleveland Clinic

More Information

No publications provided

Responsible Party:	Cleveland Clinic ( Priya Kumar, M.D. )
Study ID Numbers:	08-671
Study First Received:	January 16, 2009
Last Updated:	January 16, 2009
ClinicalTrials.gov Identifier:	NCT00825786 History of Changes
Health Authority:	United States: Institutional Review Board

Keywords provided by Outcomes Research Consortium:

surgery for arm hand or elbow
Local anesthetic
mepivacaine
ropivacaine

Study placed in the following topic categories:

Mepivacaine
Ropivacaine
Central Nervous System Depressants

Anesthetics
Peripheral Nervous System Agents
Anesthetics, Local

Additional relevant MeSH terms:

Mepivacaine
Sensory System Agents
Ropivacaine
Therapeutic Uses
Physiological Effects of Drugs
Central Nervous System Depressants

Anesthetics
Peripheral Nervous System Agents
Central Nervous System Agents
Pharmacologic Actions
Anesthetics, Local

ClinicalTrials.gov processed this record on May 07, 2009