Completed

Minimum Effective Concentration of Bupivacaine in Ultrasound-guided Axillary Brachial Plexus Block

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What is being tested

Bupivacaine

Drug
Who is being recruted

Neurologic Manifestations+1

+ Signs and Symptoms

+ Pathological Conditions, Signs and Symptoms

From 18 to 65 Years
+8 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Basic Science Study

Interventional
Study Start: August 2010
See protocol details

Summary

Principal SponsorFederal University of São Paulo
Last updated: April 24, 2013
Sourced from a government-validated database.Claim as a partner

Study start date: August 1, 2010

Actual date on which the first participant was enrolled.

The demographic data of all included patients were recorded. Routine monitoring of the surgical procedure, including electrocardiography, non-invasive blood pressure and pulse oximetry, was performed. Peripheral venous access was established in the nonoperative upper limb and standard intravenous premedication (0.03 mgkg of midazolan) was administered to all patients. Brachial plexus blocks were performed through the axilla on patients in a supine position using a ultrasound device with a 13-6 MHz linear transducer (SonoSite, Bothell, WA, USA) and a Stimuplex® DIG RC peripheral nerve stimulator (B. Braun, Melsung, Germany). The end of the local anesthetic injection was considered time 0 for evaluating the effectiveness of the block. A blinded observer, who was not present during the injection and was unaware of the concentration of local anesthetic used, assessed motor, thermal and sensory blocks. These assessments were performed every 5 minutes after the procedure for 30 minutes or until the block was deemed effective. Motor function was assessed using a modified Bromage scale. The following muscles were assessed: finger flexors (median nerve), finger extensors (radial nerve), finger adductors (ulnar nerve) and elbow flexion (musculocutaneos nerve).The assessment of thermal sensation in the upper limb was performed using gauze and alcohol. Pain sensation was assessed by a pinprick test using a 23 G needle. The thermal and pain sensitivities of the ulnar, median, radial and musculocutaneos were examined. Surgical anesthesia was defined as a motor scale of 2 or lower, with absent of appreciation of cold and pinprick sensation. Patients who exhibited block failure received an ultrasound-guided complement to the nerve block distal to axilla or conversion to general anestehesia. All patients received a subcutaneous injection of 3 mL of a 2% lidocaine solution with epinephrine as a supplementary intercostobrachial block due to the use of a pneumatic tourniquet on the middle third of the arm. During surgery, an infusion of 25-50 mcg.kg-1.min-1 of propofol was used to achieve proper sedation. Postoperative analgesia was assessed in the recovery room using a numeric pain rating scale (0 indicating no pain, 10 indicating the worst pain ever experienced) and the amount of analgesic used at four hours after the ABPB. After the surgical procedure, the patients were admitted to the recovery room, where they were monitored until they met the conditions for discharge into an outpatient regimen. Statistical Analysis In this study, the primary objective was to estimate the minimum effective concentration of a 5-mL bupivacaine solution without epinephrine for ultrasound-guided ABPB. Volume assignment was carried out using a biased coin design up-and-down sequential method.The initial concentration of local anesthetic was 0.35%. This dose was chosen based on our clinical experience and statistical simulation at various doses. Each subsequent dose was based on the response of the preceding subject, as per a biased-coin design up-down sequential method.6 The dosing changes were in increments of 0,05%. The anesthesia provider was blinded to the concentration of bupivacaine, as was the subject. If a failure was observed in the previous subject, the dose was stepped up in the next subject. If a success was observed, the next subject was randomized with probability of 0.1 to the next lower dose and with probability of 0.9 to the same dose. The ED95 with 95% confidence intervals (CIs) and estimated probabilities were calculated using logistic regression with SAS software. A sample size of at least 40 patients was selected after testing a variety of scenarios, each with simulations of both the responses and the corresponding doses selected by the sequential allocation method described above, and beginning with various starting doses. The means and standard deviations were used to analyse parametric data, whereas medians and quartiles were used to analyse non-parametric data.

Principal SponsorFederal University of São Paulo
Last updated: April 24, 2013
Sourced from a government-validated database.Claim as a partner

Protocol

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

46 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Basic Science Study

Basic science studies help researchers understand how the body works or how a disease develops. They don't test treatments, but they build the foundation for future therapies.



Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 18 to 65 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsPain

Criteria

4 inclusion criteria required to participate
BMI < 35 kg;m@

between 18 and 65 years of age

patients with a physical condition of I or II according to the American Society of Anesthesiologists

unilateral hand surgery

4 exclusion criteria prevent from participating
bleeding diathesis

contraindication to regional anesthesia

inability to visualize one or more nerves in the axilla

psychiatric history

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

One single intervention group is designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

Experimental

Study Objectives

Primary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Federal University of Sao Paulo

São Paulo, BrazilOpen Federal University of Sao Paulo in Google Maps
CompletedOne Study Center