AnalgesiaPhase 4NCT02916342
Interscalene Block Versus Combined Supraprascapular: Axillary Nerve Blocks
A Phase 4 study testing Interscalene brachial plexus block and Supraclavicular-axillary nerve blocks in people with Analgesia and Diaphragm, run by Centre Hospitalier Universitaire Vaudois at 1 site in Switzerland.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- What is being tested?
- Interscalene brachial plexus block and Supraclavicular-axillary nerve blocks
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteSwitzerland
- Study dates
- Sep 2016to Apr 2019
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ASA physical status I-III;
- 18-85 years of age, inclusive;
- surgery less than 3 hours.
Who cannot join
- 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;
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- chest deformity;
- inability to understand the informed consent and demands of the study;
- patient refusal.
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
Lausanne University Hospital
Lausanne, Canton of Vaud, 1011
About this study
Official title: 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.
- Being tested
- Interscalene brachial plexus block, Supraclavicular-axillary nerve blocks
- Medical subject headings
- Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Interscalene brachial plexus blockProcedure or surgery
Patients will receive an ultrasound-guided interscalene brachial plexus block before general anaesthesia.
Supraclavicular-axillary nerve blocksProcedure or surgery
Patients will receive ultrasound-guided supraclavicular and axillary nerve blocks before general anaesthesia.
| Study group | Role | What they receive |
|---|---|---|
| Interscalene brachial plexus block | Active comparator | An ultrasound-guided interscalene brachial plexus block will be performed prior to surgery. Receives: Procedure: Interscalene brachial plexus block |
| Supraclavicular-axillary nerve blocks | Experimental | A dual supraclavicular-axillary nerve blocks will be performed prior to surgery. Receives: Procedure: Supraclavicular-axillary nerve blocks |
What is being measured
The primary outcome is the main question the study is designed to answer.
Presence of hemidiaphragmatic paresis (yes/no)
Measured: 30 minutes after the injection
Secondary outcomes (7)
Forced expiratory volume in 1 second (liters)
Measured: 30 minutes after the injection
Peak expiratory flow (liters/minute)
Measured: 30 minutes after the injection
Forced vital capacity (liters)
Measured: 30 minutes after the injection
Pain scores in phase 1 recovery (visual analogue scale, 0-10)
Visual analogue scale, 0-10
Measured: 2 hours after surgery
Pain scores at 24 hours postoperatively (visual analogue scale, 0-10)
Visual analogue scale, 0-10
Measured: Postoperative day 1
Intravenous morphine consumption in phase 1 recovery (mg)
Measured: 2 hours postoperatively
Oxycodone consumption at 24 hours postoperatively (mg)
Measured: Postoperative day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Sep 2016 (estimated)
- Study startSep 2016
- Primary completionApr 2019
- Study completionApr 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AnalgesiaStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire VaudoisThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire Vaudois
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Eric Albrecht, Centre Hospitalier Universitaire Vaudois
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02916342
- Sponsor's protocol ID
- 2016-00889
- Other IDs
- 2016
- Status last verified
- Nov 2019
- First submitted
- 26 Sep 2016
- Last updated
- 4 Nov 2019
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 4 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Interscalene Brachial Block Versus Combined Supraprascapular: Axillary Nerve Blocks - Respiratory and Acute Pain-related Outcomes
- ClinicalTrials.gov ID
- NCT02916342
- Acronym / sponsor ID
- 2016-00889
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire VaudoisUniversity, hospital or other
- Study start
- Sep 2016
- Primary completion
- Apr 2019 (actual)
- Study completion
- Apr 2019 (actual)
- First posted
- 27 Sep 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Interscalene brachial plexus block | Active comparator | Procedure: Interscalene brachial plexus blockAn ultrasound-guided interscalene brachial plexus block will be performed prior to surgery. |
| Supraclavicular-axillary nerve blocks | Experimental | Procedure: Supraclavicular-axillary nerve blocksA dual supraclavicular-axillary nerve blocks will be performed prior to surgery. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- ASA physical status I-III;
- 18-85 years of age, inclusive;
- surgery less than 3 hours.
Key exclusion criteria (9 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Interscalene brachial plexus blockPatients will receive an ultrasound-guided interscalene brachial plexus block before general anaesthesia. | Procedure or surgery | Interscalene brachial plexus block |
| Supraclavicular-axillary nerve blocksPatients will receive ultrasound-guided supraclavicular and axillary nerve blocks before general anaesthesia. | Procedure or surgery | Supraclavicular-axillary nerve blocks |
Primary outcome
Presence of hemidiaphragmatic paresis (yes/no)
Time frame: 30 minutes after the injection
7 secondary outcomes
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)
Time frame: 2 hours after surgery
Pain scores at 24 hours postoperatively (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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Nov 2019.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Interscalene brachial plexus block and Supraclavicular-axillary nerve blocks in people with Analgesia and Diaphragm, run by Centre Hospitalier Universitaire Vaudois at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Nov 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Presence of hemidiaphragmatic paresis (yes/no) (time frame: 30 minutes after the injection). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Nov 2019.