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

NCT02086643 | Completed Phase 4

• 1 other identifier: 13-175
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

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)

Conditions

Overweight

Keywords

Infraclavicular block; Brachial Plexus; Retroclavicular Approach; Complications of retroclavicular approach; Success of retroclavicular approach; Obese Patients; Obesity and Anesthesia

Outcome Measures

Primary Outcomes (1)

• Surgery completion under regional block

  Success rate is defined as the completion of the intended surgery under regional anesthesia with retroclavicular block without the need for a rescue technique. These techniques are defined as: adding local anesthetic locally by surgeon, rescue intravenous narcotics in excess of 1 microgram per kilogram of patient weight, need for general anesthesia, rescue distal neural blockage by anesthesiologist. Patient sedation with midazolam 1 to 2 mg IV or propofol perfusion up to 50 mcg/kg/min is allowed for patient comfort during the surgery and is not considered a rescue technique.

  Success is defined at end of surgery for which block was done, generally within 1 to 3 hours after block is performed

Secondary Outcomes (12)

• Sensitive block progression

  Assessed 10, 20 and 30 minutes after block completion

• Motor Block Progression

  Assessed 10, 20, 30 minutes after the block

• Technique duration

  Time required in seconds for the retroclavicular block technique completion, generally under 15 minutes

• Needle visualization

  Assessed after study completion, once all 30 patients will have been completed. Assessment will take place in the first 4 weeks after all 30 patients have been recruited

• Patient discomfort

  Assessed 1 minute after block completion

Study Arms (1)

Retroclavicular block

EXPERIMENTAL

Retroclavicular block

Procedure: Retroclavicular block

Interventions

Retroclavicular block 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.

Retroclavicular block

Eligibility Criteria

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

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Université de Sherbrooke: lead

Study Sites (1)

Centre hospitalier universitaire de Sherbrooke (CHUS)

Sherbrooke, Quebec, J1H 5N4, Canada

Location

MeSH Terms

Conditions

Overweight; Obesity

Condition Hierarchy (Ancestors)

Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Pablo Echave, M.D.

  Université de Sherbrooke

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Anesthesiologist

Study Record Dates

• First Submitted: March 8, 2014
• First Posted: March 13, 2014
• Study Start: December 1, 2013
• Primary Completion: October 1, 2015
• Study Completion: October 1, 2015
• Last Updated: October 6, 2015

Record last verified: 2015-10

Locations

CA (1)