Clinical trial NCT02916342: Interscalene Block Versus Combined Supraprascapular: Axillary Nerve Blocks
Official title: Interscalene Brachial Block Versus Combined Supraprascapular: Axillary Nerve Blocks - Respiratory and Acute Pain-related Outcomes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Analgesia
Diaphragm
Lead sponsor: Centre Hospitalier Universitaire Vaudois
Sponsor class: OTHER
First posted: 2016-09-27
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.


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.

Primary outcomes:
measure: Presence of hemidiaphragmatic paresis (yes/no)
timeFrame: 30 minutes after the injection
Secondary outcomes:
measure: Forced expiratory volume in 1 second (liters)
timeFrame: 30 minutes after the injection
measure: Peak expiratory flow (liters/minute)
timeFrame: 30 minutes after the injection
measure: Forced vital capacity (liters)
timeFrame: 30 minutes after the injection
measure: Pain scores in phase 1 recovery (visual analogue scale, 0-10)
timeFrame: 2 hours after surgery
measure: Pain scores at 24 hours postoperatively (visual analogue scale, 0-10)
timeFrame: Postoperative day 1
measure: Intravenous morphine consumption in phase 1 recovery (mg)
timeFrame: 2 hours postoperatively
measure: Oxycodone consumption at 24 hours postoperatively (mg)
timeFrame: Postoperative day 1
Other outcomes:
Locations:
city: Lausanne
country: Switzerland
facility: Lausanne University Hospital
state: Vaud
Study officials:
References: