The Retroclavicular Approach for Regional Anesthesia of the Upper Limb in Obese Patients

NCT ID: NCT02086643

Last Updated: 2015-10-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 32 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-12-31
• Study Completion Date: 2015-10-31

Brief Summary

The goal of this study is to determine the success rate of the retroclavicular approach for the anesthesia of the upper limb in the obese patient population (BMI ≥ 30 kg/m2)

Detailed Description

Classic infraclavicular approach of the brachial plexus involves a needle puncture below the clavicle and advancing the needle with a 45-60 degree angle from cephalad to caudad. The aim is to advanced the block needle posterior to the axillary artery and to deposit the local anesthetic at that point, near the posterior cord. A "U" shaped spread around the artery should ensure distribution around all three cords. Ultrasound guidance is highly recommended and neurostimulation is optional.

The retroclavicular approach is a variant to this classical technique. Ultrasound probe is positioned initially below the clavicle in a manner similar to the classic approach but is then rotated in a clockwise fashion (right arm) or counter-clockwise fashion (left arm) for about 25-35 degrees. The puncture site is just behind the clavicle at the most lateral point available. If initial entry point is optimal, needle direction is then parallel to ultrasound probe. The final aim and position of block needle is identical to classical approach. Entry point ensures a parallel alignment of the needle and the ultrasound beam, thus enabling almost perfect visualization of both artery, cords and block needle. This is turn optimizes safety, rapidity of technique, efficiency and efficacy.

It is recognized that regional anesthesia is more difficult to perform in obese patients. Anatomic landmarks are harder to localize in this population and ultrasound guidance is more difficult because of the attenuation of the ultrasound beam by adipose tissue. The complication rate of regional techniques is also reported to be higher in the obese patient population.

Since the retroclavicular variant of the infraclavicular approach for the anesthesia of the brachial plexus offers a better needle visualisation, we believe that this technique can be used successfully in the obese patient population with a low complication rate.

Conditions

Overweight

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Retroclavicular block

Retroclavicular block

Group Type: EXPERIMENTAL

Retroclavicular block

Intervention Type: PROCEDURE

Retroclavicular ultrasound guided nerve block with total injection of 40 ml of a mixture of 20 ml ropivacaine 0,5% (5 mg/ml) + 20 ml mepivacaine 1,5% (15 mg/ml) + epinephrine 1 : 400 000 (2,5 mcg/ml). Incremental injections of 5 ml separated by an aspiration test.

Interventions

Retroclavicular block

Retroclavicular ultrasound guided nerve block with total injection of 40 ml of a mixture of 20 ml ropivacaine 0,5% (5 mg/ml) + 20 ml mepivacaine 1,5% (15 mg/ml) + epinephrine 1 : 400 000 (2,5 mcg/ml). Incremental injections of 5 ml separated by an aspiration test.

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

• Elective or Urgent Surgery of the hand, wrist or forearm
• 18 years and older
• Ability to consent
• American Society of Anesthesiologists class 1 to 3
• BMI ≥ 30 kg/m2

Exclusion Criteria

• Infection at the site of infection
• Abnormal anatomy at the site of infection
• Coagulopathy
• Severe Pulmonary Disease
• Preexisting neurological symptom(s) in the operated arm
• Pregnant patients
• Patients weighing less than 50 kg
• Allergy to amide type local anesthetics

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

Sponsors

Université de Sherbrooke

OTHER

Sponsor Role: lead

Responsible Party

Pablo Echave

Anesthesiologist

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Pablo Echave, M.D.

Role: PRINCIPAL_INVESTIGATOR

Université de Sherbrooke

Locations

Centre hospitalier universitaire de Sherbrooke (CHUS)

Sherbrooke, Quebec, Canada

Countries

Canada

Other Identifiers

13-175

Identifier Type: -

Identifier Source: org_study_id