Interscalene Block Versus Combined Supraprascapular: Axillary Nerve Blocks

NCT ID: NCT02916342

Last Updated: 2019-11-04

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-09-30
• Study Completion Date: 2019-04-30

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: SINGLE

Study Groups

Interscalene brachial plexus block

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

Group Type: ACTIVE_COMPARATOR

Interscalene brachial plexus block

Intervention Type: PROCEDURE

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

Supraclavicular-axillary nerve blocks

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

Group Type: EXPERIMENTAL

Supraclavicular-axillary nerve blocks

Intervention Type: PROCEDURE

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

Interventions

Interscalene brachial plexus block

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

Intervention Type: PROCEDURE

Supraclavicular-axillary nerve blocks

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

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

• ASA physical status I-III;
• 18-85 years of age, inclusive;
• surgery less than 3 hours.

Exclusion Criteria

• 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.

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

Sponsors

Centre Hospitalier Universitaire Vaudois

OTHER

Sponsor Role: lead

Responsible Party

Eric Albrecht

PD Dr

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Lausanne University Hospital

Lausanne, Canton of Vaud, Switzerland

Countries

Switzerland

Other Identifiers

2016-00889

Identifier Type: -

Identifier Source: org_study_id