Interscalene Block Versus Combined Supraprascapular: Axillary Nerve Blocks

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

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.

Study Overview

• Status: Completed
• Conditions: Analgesia; Diaphragm
• Intervention / Treatment: Procedure: Interscalene brachial plexus block; Procedure: Supraclavicular-axillary nerve blocks

• Study Type: Interventional
• Enrollment (Actual): 30
• Phase: Phase 4

Contacts and Locations

Study Locations

• Switzerland
  • Vaud
    • Lausanne, Vaud, Switzerland, 1011
      • Lausanne University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Interscalene brachial plexus block; An ultrasound-guided interscalene brachial plexus block will be performed prior to surgery.	Procedure: Interscalene brachial plexus block; Patients will receive an ultrasound-guided interscalene brachial plexus block before general anaesthesia.
Experimental: Supraclavicular-axillary nerve blocks; A dual supraclavicular-axillary nerve blocks will be performed prior to surgery.	Procedure: Supraclavicular-axillary nerve blocks; Patients will receive ultrasound-guided supraclavicular and axillary nerve blocks before general anaesthesia.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Presence of hemidiaphragmatic paresis (yes/no)	30 minutes after the injection

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)	Visual analogue scale, 0-10	2 hours after surgery
Pain scores at 24 hours postoperatively (visual analogue scale, 0-10)	Visual analogue scale, 0-10	Postoperative day 1
Intravenous morphine consumption in phase 1 recovery (mg)		2 hours postoperatively
Oxycodone consumption at 24 hours postoperatively (mg)		Postoperative day 1

Collaborators and Investigators

• Sponsor: Centre Hospitalier Universitaire Vaudois

Study record dates

Study Major Dates

• Study Start: September 1, 2016
• Primary Completion (Actual): April 1, 2019
• Study Completion (Actual): April 1, 2019

Study Registration Dates

• First Submitted: September 26, 2016
• First Submitted That Met QC Criteria: September 26, 2016
• First Posted (Estimate): September 27, 2016

Study Record Updates

• Last Update Posted (Actual): November 4, 2019
• Last Update Submitted That Met QC Criteria: November 1, 2019
• Last Verified: November 1, 2019

More Information

Terms related to this study

• Other Study ID Numbers: 2016-00889

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES