A Phase 4 interventional study of Interscalene brachial plexus block and Supraclavicular-axillary nerve blocks in Analgesia and Diaphragm, sponsored by Centre Hospitalier Universitaire Vaudois. Completed at 1 site in Switzerland. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2019-11-04.
Sponsored by Centre Hospitalier Universitaire Vaudois · Phase 4, Interventional, and Other
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.
Centre Hospitalier Universitaire Vaudois is the lead sponsor of 203 studies on the registry; 47 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
An ultrasound-guided interscalene brachial plexus block will be performed prior to surgery.
Procedure: Interscalene brachial plexus block
A dual supraclavicular-axillary nerve blocks will be performed prior to surgery.
Procedure: Supraclavicular-axillary nerve blocks
Patients will receive an ultrasound-guided interscalene brachial plexus block before general anaesthesia.
Patients will receive ultrasound-guided supraclavicular and axillary nerve blocks before general anaesthesia.
Presence of hemidiaphragmatic paresis (yes/no)
Time frame: 30 minutes after the injection
Forced expiratory volume in 1 second (liters)
Time frame: 30 minutes after the injection
Peak expiratory flow (liters/minute)
Time frame: 30 minutes after the injection
Forced vital capacity (liters)
Time frame: 30 minutes after the injection
Pain scores in phase 1 recovery (visual analogue scale, 0-10)
Visual analogue scale, 0-10
Time frame: 2 hours after surgery
Pain scores at 24 hours postoperatively (visual analogue scale, 0-10)
Visual analogue scale, 0-10
Time frame: Postoperative day 1
Intravenous morphine consumption in phase 1 recovery (mg)
Time frame: 2 hours postoperatively
Oxycodone consumption at 24 hours postoperatively (mg)
Time frame: Postoperative day 1
Plan to share: Yes
No publications or documents are linked to this record.
This study is completed, as verified in Nov 2019. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Centre Hospitalier Universitaire Vaudois