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

NCT ID: NCT01452126

Last Updated: 2016-12-19

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE2
• Total Enrollment: 49 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-06-30
• Study Completion Date: 2011-09-30

Brief Summary

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.

Conditions

Surgical Anesthesia

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Blinding Strategy: TRIPLE

Study Groups

Ropivacaine

Sequential allocation of ropivacaine concentration depending on the success or failure of surgical anesthesia of the previous patient

Group Type: EXPERIMENTAL

Ropivacaine concentration

Intervention Type: DRUG

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

Interventions

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

Intervention Type: DRUG

Eligibility Criteria

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

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

Sponsors

University of New Mexico

OTHER

Sponsor Role: lead

Responsible Party

Timothy R Petersen

Research Information Specialist

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Nicholas Lam, MD

Role: PRINCIPAL_INVESTIGATOR

University of New Mexico

Locations

Univeristy of Mexico Outpatient Surgical and imaging service

Albuquerque, New Mexico, United States

Countries

United States

Other Identifiers

UNM HRRC 11-030

Identifier Type: -

Identifier Source: org_study_id