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

NCT01452126 | Terminated Phase 2 Results DMC

• 1 other identifier: UNM HRRC 11-030
• Study Type: interventional
• Target: 49
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• Effective Concentration of Ropivacaine to Produce Surgical Anesthesia in 50% of Population

  The concentration of ropivacaine for each patient's nerve-block injection was determined per protocol.

  1 day

Secondary Outcomes (1)

• Number of Patients With Complications

  3 days

Study Arms (1)

Ropivacaine

EXPERIMENTAL

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

Drug: Ropivacaine concentration

Interventions

Ropivacaine concentration 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

Ropivacaine

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• University of New Mexico: lead

Study Sites (1)

Univeristy of Mexico Outpatient Surgical and imaging service

Albuquerque, New Mexico, 87102, United States

Location

Limitations and Caveats

Early termination leading to small numbers of subjects analyzed. Confidence intervals for primary outcome are not reliable and therefore not reported.

Results Point of Contact

• Title: Dr Tim Petersen
• Organization: UNM Department of Anesthesiology

timpetersen@salud.unm.edu

5052722610

Study Officials

• Nicholas Lam, MD

  University of New Mexico

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Information Specialist

Study Record Dates

• First Submitted: October 11, 2011
• First Posted: October 14, 2011
• Study Start: June 1, 2011
• Primary Completion: September 1, 2011
• Study Completion: September 1, 2011
• Last Updated: December 19, 2016
• Results First Posted: December 19, 2016

Record last verified: 2016-10

Locations

US (1)