Minimum Effective Concentration of Ropivacaine for Brachial Plexus Block Via the Supraclavicular and Infraclavicular Approach, Femoral Nerve Block, Sciatic Nerve Block Via the Popliteal and Parasacral Approach (MEAC)

October 25, 2016 updated by: Timothy R Petersen, University of New Mexico

Minimum Effective Anesthetic Concentration of Supraclavicular Block, Infraclavicular Block, Femoral Nerve Block and Sciatic Nerve Block Via the Popliteal and Parasacral Approach

This is a dose finding study to identify the minimum effective anesthetic concentration (MEAC) of ropivacaine to produce insensate body parts sufficient for surgery in supraclavicular and infraclavicular approaches to the brachial plexus, parasacral and popliteal approaches to the sciatic nerve, femoral nerve and transversus abdominis plane (TAP) blocks in adults.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

49

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New Mexico
      • Albuquerque, New Mexico, United States, 87102
        • Univeristy of Mexico Outpatient Surgical and imaging service

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • American Society of Anesthesiologists physical status I to III (patients may be healthy or have systemic disease, but any disease does not pose a constant threat to life, and patients are neither moribund, nor not expected to survive without the operation).
  • Age 18 or above
  • Undergoing elective ambulatory surgery of the upper limb (excluding the shoulder), lower limb (excluding the hip), or lower abdomen with sensory blockade as part of the pain management plan.

Exclusion Criteria:

  • Body mass index of >35 kg/m2 (higher chance of failure)
  • Deformities of the leg (for patients in the parasacral, femoral, and popliteal groups), or the chest or shoulder (for patients in the supraclavicular, infraclavicular, and TAP groups)
  • Preexisting infection at the injection site
  • Existing neurologic disease
  • Allergy to local anesthetic agents
  • Severe respiratory disease
  • Coagulopathy
  • Any other contraindication to the block being considered
  • Patients requiring total motor blockade as well as sensory blockade

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Ropivacaine
Sequential allocation of ropivacaine concentration depending on the success or failure of surgical anesthesia of the previous patient
Drug: Ropivacaine concentration
Single shot preoperative perineural injection of ropivacaine to achieve surgical anesthesia. The concentration of ropivacaine is lowered by 0.05% after every successful surgical anesthesia specific to that block and raised by 0.05% after every unsuccessful surgical anesthesia specific to that block

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Effective Concentration of Ropivacaine to Produce Surgical Anesthesia in 50% of Population
Time Frame: 1 day
The concentration of ropivacaine for each patient's nerve-block injection was determined per protocol.
1 day

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Patients With Complications
Time Frame: 3 days
All patients were followed up for complications such as bleeding, infection, side effects, nerve damage
3 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of New Mexico

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2011

Primary Completion (Actual)

September 1, 2011

Study Completion (Actual)

September 1, 2011

Study Registration Dates

First Submitted

October 11, 2011

First Submitted That Met QC Criteria

October 11, 2011

First Posted (Estimate)

October 14, 2011

Study Record Updates

Last Update Posted (Estimate)

December 19, 2016

Last Update Submitted That Met QC Criteria

October 25, 2016

Last Verified

October 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • UNM HRRC 11-030

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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