Surgical Anesthesia Clinical Trial
— MEACOfficial title:
Minimum Effective Anesthetic Concentration of Supraclavicular Block, Infraclavicular Block, Femoral Nerve Block and Sciatic Nerve Block Via the Popliteal and Parasacral Approach
| Verified date | December 2013 |
| Source | University of New Mexico |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | United States: Institutional Review Board |
| Study type | Interventional |
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.
| Status | Suspended |
| Enrollment | 20 |
| Est. completion date | June 2014 |
| Est. primary completion date | June 2014 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 18 Years and older |
| Eligibility |
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 |
Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Caregiver, Outcomes Assessor)
| Country | Name | City | State |
|---|---|---|---|
| United States | Univeristy of Mexico Outpatient Surgical and imaging service | Albuquerque | New Mexico |
| Lead Sponsor | Collaborator |
|---|---|
| University of New Mexico | University of Toronto |
United States,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | effective concentration of ropivacaine to produce surgical anesthesia in 50% of population | The concentration of ropivacaine for each block will be determined by the success or failure to establish surgical anesthesia within the allocated time frame of the previous patient as per Dixon and Massey's up-and-down sequential allocation method to determine the effective concentration of ropivacaine in 50% of the population | 1 year | No |
| Secondary | Number of patients with complications and duration of action | All patients are followed up for complications such as bleeding, infection, side effects, nerve damage and the duration of the block | 1 year | Yes |