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

Phase 2

Terminated

• Conditions: Surgical Anesthesia
• Interventions: Drug: Ropivacaine concentration

• Registration Number: NCT01452126
• Lead Sponsor: University of New Mexico

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-06
• Primary Completion: 2011-09
• Study Completion: 2011-09
• Study First Submitted: 2011-10-11
• Study First Submitted QC: 2011-10-11
• Study First Posted: 2011-10-14
• Status Verified: 2016-10
• Results First Submitted: 2016-10-25
• Results First Submitted QC: 2016-10-25
• Last Update Submitted: 2016-10-25
• Results First Posted: 2016-12-19
• Last Update Posted: 2016-12-19

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 49

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Ropivacaine	Ropivacaine concentration	Sequential allocation of ropivacaine concentration depending on the success or failure of surgical anesthesia of the previous patient

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Number of Patients With Complications	3 days	All patients were followed up for complications such as bleeding, infection, side effects, nerve damage

Trial Locations

Locations (1)

Univeristy of Mexico Outpatient Surgical and imaging service; 🇺🇸 Albuquerque, New Mexico, United States