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Retroclavicular Approach vs Infraclavicular Approach for Plexic Bloc Anesthesia of the Upper Limb

U

Université de Sherbrooke

Status

Completed

Conditions

Hand Injury

Treatments

Other: Ultrasound guided infraclavicular block
Other: Ultrasound guided retroclavicular block

Study type

Interventional

Funder types

Other

Identifiers

NCT02913625
MP-31-2017-1298

Details and patient eligibility

About

Locoregional anesthesia provides several advantages over general anesthesia in terms of postoperative pain, decreased postoperative opioid needs and reduced recovery time for patients undergoing orthopaedic surgery.

For upper limb surgery, the coracoid infraclavicular brachial plexus block is generally preferred because of its simplicity and effectiveness but, needle visibility remains a challenge because of the angle between the ultrasound beam and the needle.

The retroclavicular approach for brachial plexus anesthesia requires an angle between the needle and the ultrasound beam that is less steep than the angle required to perform an infraclavicular coracoid block. This approach has already been proven effective and safe in the past.

The general objective is to provide a formal comparison between the retroclavicular approach and coracoid infraclavicular approach for brachial plexus anaesthesia. This study will delineate the differences between the two techniques.

Full description

Investigators aim is to compare both techniques in terms of scanning time, needling time, total anesthesia time, needle visibility, block needle passes, block success and early and late complications. Investigators made the hypothesis that, while providing similar efficacy and better needle visualisation than coracoid infraclavicular block, performance time of retroclavicular block will not exceed the performance time of its comparator.

This study is designed as a prospective randomized non-inferiority trial. Two groups of non-consecutive patients will be randomly assigned to either retroclavicular or coracoid infraclavicular block. This study will be carried out in three different centres simultaneously.

The multicentre trial will be conducted in two university hospitals (Centre hospitalier universitaire de Sherbrooke [CHUS] Hôtel-Dieu/Fleurimont and Centre Hospitalier de l'Université Laval [CHUL] in Quebec city) and a community hospital (Cowansville). The third participating establishment, Brome-Missisquoi-Perkins hospital, is located in Cowansville, a peripheral city of 15,000 people.

Enrollment

110 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Elective or urgent surgery of the hand, wrist, forearm or elbow.
  • Age >18 years old.
  • ASA (American Society of Anesthesiologists) class 1, 2 and 3.
  • Able to provide valid written consent.
  • Minimum body weight of 50 kg, despite BMI

Exclusion criteria

  • Patient refusal.
  • Previous surgery or gross anatomical deformity of the clavicle.
  • Systemic or local infection at needle entry point.
  • Coagulopathy.
  • Severe pulmonary condition.
  • Local anaesthetic allergy.
  • Pre-existing neurologic symptoms in the ipsilateral limb.
  • Pregnancy.
  • Surgical request of an indwelling catheter for post-operative analgesia

Trial design

Primary purpose

Supportive Care

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Triple Blind

110 participants in 2 patient groups

Ultrasound guided retroclavicular block
Experimental group
Description:
Patients assigned to this group will receive an ultrasound guided retroclavicular brachial plexus block
Treatment:
Other: Ultrasound guided retroclavicular block
Ultrasound guided infraclavicular block
Active Comparator group
Description:
Patients assigned to this group will receive an ultrasound guided infraclavicular brachial plexus block
Treatment:
Other: Ultrasound guided infraclavicular block

Trial contacts and locations

2

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Data sourced from clinicaltrials.gov

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