Interscalene Block Versus Combined Supraprascapular: Axillary Nerve Blocks

Analgesia Clinical Trial

Official title:

Interscalene Brachial Block Versus Combined Supraprascapular: Axillary Nerve Blocks - Respiratory and Acute Pain-related Outcomes

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02916342
• Other study ID #: 2016-00889
• Status: Completed
• Phase: Phase 4
• Start date: September 2016
• Est. completion date: April 2019

Study information

• Verified date: November 2019
• Source: Centre Hospitalier Universitaire Vaudois
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: April 2019
• Est. primary completion date: April 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Analgesia
• Diaphragm

Intervention

Procedure:
• Interscalene brachial plexus block
Patients will receive an ultrasound-guided interscalene brachial plexus block before general anaesthesia.
• Supraclavicular-axillary nerve blocks
Patients will receive ultrasound-guided supraclavicular and axillary nerve blocks before general anaesthesia.

Locations

Country	Name	City	State
Switzerland	Lausanne University Hospital	Lausanne	Vaud

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire Vaudois

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Presence of hemidiaphragmatic paresis (yes/no)		30 minutes after the injection
Secondary	Forced expiratory volume in 1 second (liters)		30 minutes after the injection
Secondary	Peak expiratory flow (liters/minute)		30 minutes after the injection
Secondary	Forced vital capacity (liters)		30 minutes after the injection
Secondary	Pain scores in phase 1 recovery (visual analogue scale, 0-10)	Visual analogue scale, 0-10	2 hours after surgery
Secondary	Pain scores at 24 hours postoperatively (visual analogue scale, 0-10)	Visual analogue scale, 0-10	Postoperative day 1
Secondary	Intravenous morphine consumption in phase 1 recovery (mg)		2 hours postoperatively
Secondary	Oxycodone consumption at 24 hours postoperatively (mg)		Postoperative day 1