Interscalene Block Versus Combined Supraprascapular: Axillary Nerve Blocks

NCT02916342 | Completed Phase 4 DMC

• 1 other identifier: 2016-00889
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

The interscalene block provides effective analgesia after shoulder surgery. It consists of injecting local anaesthetic within the brachial plexus, in the interscalene groove, between the anterior and middle scalene muscles. Unfortunately, this technique is associated with respiratory complications such as hemidiaphragmatic paresis due to the spread of the local anaesthetic towards the phrenic nerve that lies close to the brachial plexus, with an incidence up to 100%. The diaphragmatic paresis may be a serious side-effect, especially in patients suffering from a reduced respiratory function such as chronic obstructive pulmonary disease; this entity may even represent a contraindication to the performance of the block. The shoulder is mainly innervated by the suprascapular and axillary nerves, both of them coming from C5 and C6 branches of the brachial plexus block. Recently, several authors have successfully identified and block these two nerves under ultrasound guidance. Only one randomised controlled trial compared interscalene block with a combination of suprascapular and axillary nerve blocks, and showed inconclusive results probably due to the absence of ultrasound guidance; indeed, analgesia was equivalent at the sixth postoperative hour, while patients with an interscalene block had reduced pain scores in the recovery room. Besides, the authors did not investigate the impact on the respiratory function. In that randomised controlled trial, the investigators would like to compare the analgesic efficacy and the respiratory outcomes between the interscalene block and the combined suprascapular-axillary nerve blocks.

Conditions

Analgesia; Diaphragm

Outcome Measures

Primary Outcomes (1)

• Presence of hemidiaphragmatic paresis (yes/no)

  30 minutes after the injection

Secondary Outcomes (7)

• Forced expiratory volume in 1 second (liters)

  30 minutes after the injection

• Peak expiratory flow (liters/minute)

  30 minutes after the injection

• Forced vital capacity (liters)

  30 minutes after the injection

• Pain scores in phase 1 recovery (visual analogue scale, 0-10)

  2 hours after surgery

• Pain scores at 24 hours postoperatively (visual analogue scale, 0-10)

  Postoperative day 1

Study Arms (2)

Interscalene brachial plexus block

ACTIVE COMPARATOR

An ultrasound-guided interscalene brachial plexus block will be performed prior to surgery.

Procedure: Interscalene brachial plexus block

Supraclavicular-axillary nerve blocks

EXPERIMENTAL

A dual supraclavicular-axillary nerve blocks will be performed prior to surgery.

Procedure: Supraclavicular-axillary nerve blocks

Interventions

Interscalene brachial plexus block PROCEDURE

Patients will receive an ultrasound-guided interscalene brachial plexus block before general anaesthesia.

Interscalene brachial plexus block

Supraclavicular-axillary nerve blocks PROCEDURE

Patients will receive ultrasound-guided supraclavicular and axillary nerve blocks before general anaesthesia.

Supraclavicular-axillary nerve blocks

Eligibility Criteria

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

You may qualify if:

• ASA physical status I-III;
• years of age, inclusive;
• surgery less than 3 hours.

You may not qualify if:

• indication for catheter insertion;
• contraindications to brachial plexus block (e.g., allergy to local anaesthetics, malignancy or infection in the area);
• existing neurological deficit in the area to be blocked;
• pregnancy;
• history of neck surgery or radiotherapy;
• severe respiratory disease;
• chest deformity;
• inability to understand the informed consent and demands of the study;
• patient refusal.

Sponsors & Collaborators

• Centre Hospitalier Universitaire Vaudois: lead

Study Sites (1)

Lausanne University Hospital

Lausanne, Canton of Vaud, 1011, Switzerland

Location

MeSH Terms

Conditions

Agnosia

Condition Hierarchy (Ancestors)

Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PD Dr

Study Record Dates

• First Submitted: September 26, 2016
• First Posted: September 27, 2016
• Study Start: September 1, 2016
• Primary Completion: April 1, 2019
• Study Completion: April 1, 2019
• Last Updated: November 4, 2019

Record last verified: 2019-11

Data Sharing

• IPD Sharing: Will share

Locations

CH (1)