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NCT Number: NCT02916342

Interscalene Block Versus Combined Supraprascapular: Axillary Nerve Blocks

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Lausanne University Hospital

Lausanne, Canton of Vaud, 1011, Switzerland

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Interscalene brachial plexus block

Procedure

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

Supraclavicular-axillary nerve blocks

Procedure

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

Primary outcomes

  1. Presence of hemidiaphragmatic paresis (yes/no)

    Time frame: 30 minutes after the injection

Secondary outcomes

  1. Forced expiratory volume in 1 second (liters)

    Time frame: 30 minutes after the injection

  2. Peak expiratory flow (liters/minute)

    Time frame: 30 minutes after the injection

  3. Forced vital capacity (liters)

    Time frame: 30 minutes after the injection

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

    Time frame: 2 hours after surgery

    Visual analogue scale, 0-10

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

    Time frame: Postoperative day 1

    Visual analogue scale, 0-10

  6. Intravenous morphine consumption in phase 1 recovery (mg)

    Time frame: 2 hours postoperatively

  7. Oxycodone consumption at 24 hours postoperatively (mg)

    Time frame: Postoperative day 1

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire Vaudois

Other

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2019
Study completion
2019
First posted
Sep 27, 2016
Registry last updated
Nov 4, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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