SurgerySSParaDiaNCT03352687
Diaphragmatic Paralysis After Ultrasound Block of the Suprascapular Nerve for Shoulder Surgery
A study testing anterior SSAX and posterior SSAX in people with Surgery, run by University Hospital, Toulouse at 1 site in France.
Trial summary
Shoulder surgery is a source of intense postoperative pain that justifies the use of opioids. In this context, analgesia provided by locoregional anesthesia (ALR) improves the rehabilitation of patients by reducing the length of hospital stay and morphine consumption. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Surgery
- What is being tested?
- anterior SSAX and posterior SSAX
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 84 participants
- Where
- 1 siteFrance
- Study dates
- 2 Feb 2018to 28 Feb 2019
- Phase
- Interventional
- 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
- to benefit from scheduled arthroscopic surgery of the shoulder under general anesthesia
- Affiliate or beneficiary of a social security scheme
- Having signed the informed consent
Who cannot join
- the existence of contralateral diaphragmatic paralysis
- pre-existing respiratory insufficiency
- impossibility of performing diaphragmatic ultrasound
- the patient's refusal
- the existence of major spontaneous or acquired haemostatic disorders
- an infection at the point of puncture
Show all 10Show fewer
- allergy to local anesthetics
- Pregnant or likely to be pregnant
- Patients under protection of the adults (guardianship, curators or safeguard of justice)
- Patients whose cognitive state does not allow assessment by the scales used
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Diaphragmatic Paralysis After Ultrasound Block of the Suprascapular Nerve for Shoulder Surgery : Incidence and Influence of the Approach
Shoulder surgery is a source of intense postoperative pain that justifies the use of opioids. In this context, analgesia provided by locoregional anesthesia (ALR) improves the rehabilitation of patients by reducing the length of hospital stay and morphine consumption. Thus anesthesia of the brachial plexus interscalene (interscalene block or BIS) is considered as the reference technique for the management of post-operative pain after shoulder surgery. It is however provider of hemi-diaphragmatic paralysis (PhD) in nearly 100% of cases. Thus, this technique is usually avoided in patients with respiratory insufficiency. In arthroscopic shoulder surgery, the development of a suprascapular and axillary nerve (SSAX) conjugate block appears to be an effective analgesic alternative in this context.
Read the detailed description
Two ultrasound-guided approaches of the suprascapular nerve (anterior and posterior approaches) have been described in the literature. From an anatomical point of view, the anterior approach could expose patients to the risk of ipsilateral PhD by phrenic nerve block secondary to diffusion of the local anesthetic into the supraclavicular region.
By measuring the diaphragm excursion during a sniff test, ultrasound allows reliable and reproducible analysis of the diaphragm function.
No study has evaluated the incidence of PhD after ultrasound block of the suprascapular nerve. Knowing the influence of the approach on this complication could be of major interest in this context.
- Conditions
- Surgery
- Being tested
- anterior SSAX, posterior SSAX
- Keywords
- Shoulder surgery, Local regional anesthesia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
anterior SSAXProcedure or surgery
block of the suprascapular nerve block for shoulder surgery by anterior way
posterior SSAXProcedure or surgery
block of the suprascapular nerve block for shoulder surgery by posterior way
| Study group | Role | What they receive |
|---|---|---|
| Anterior SSAX | Experimental | patients receiving suprascapular and axillary nerve block (SSAX) whose approach to the SS nerve is performed by anterior route Receives: Procedure: anterior SSAX |
| Posterior SSAX | Experimental | patients receiving suprascapular and axillary nerve block (SSAX) whose approach to the SS nerve is performed by posterior route Receives: Procedure: posterior SSAX |
What is being measured
The primary outcome is the main question the study is designed to answer.
change in diaphragmatic excursion
measured on ultrasound between the 30th minute after SSAX and the basal state (i.e. prior to regional anesthesia).
The diaphragmatic excursion is the distance traveled by the diaphragm between the functional residual capacity (CRF) and the forced inspiration during a rapid voluntary sniffing (or "sniff test").
Measured: 30 minutes
Secondary outcomes (1)
PhD over time
diaphragmatic excursion by a repeated ultrasound during a "sniff test" in the basal state (ie before regional anesthesia), then 30 minutes, 4 hours and finally 8 hours after realization of the ALR
Measured: Baseline, 30 minutes, 4 hours and 8 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Nov 2017
- Study start2 Feb 2018
- Primary completion28 Jan 2019
- Study completion28 Feb 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for SurgeryStudies of the same condition, open and under way.
- More trials run by University Hospital, ToulouseThe 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 84 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Toulouse
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Fabrice FERRE, MD PhD, Principal investigator, University Hospital, Toulouse
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03352687
- Sponsor's protocol ID
- RC31/17/0141
- Other IDs
- 2017-A01378-45
- Acronym
- SSParaDia
- Status last verified
- Apr 2019
- First submitted
- 14 Nov 2017
- Last updated
- 17 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Ferre F, Pommier M, Laumonerie P, Ferrier A, Menut R, Bosch L, Balech V, Bonnevialle N, Minville V. Hemidiaphragmatic paralysis following ultrasound-guided anterior vs. posterior suprascapular nerve block: a double-blind, randomised control trial. Anaesthesia. 2020 Apr;75(4):499-508. doi: 10.1111/anae.14978. Epub 2020 Jan 26.
PubMed 31984478
Study at a glance
From the registry record, last updated by the sponsor on 17 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Diaphragmatic Paralysis After Ultrasound Block of the Suprascapular Nerve for Shoulder Surgery : Incidence and Influence of the Approach
- ClinicalTrials.gov ID
- NCT03352687
- Acronym / sponsor ID
- SSParaDia / RC31/17/0141
- Conditions
- Surgery
- Keywords
- Shoulder surgery, Local regional anesthesia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 84 participants (actual)
- Lead sponsor
- University Hospital, ToulouseUniversity, hospital or other
- Study start
- 2 Feb 2018 (actual)
- Primary completion
- 28 Jan 2019 (actual)
- Study completion
- 28 Feb 2019 (actual)
- First posted
- 24 Nov 2017 (actual)
- 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.
Shoulder surgery is a source of intense postoperative pain that justifies the use of opioids. In this context, analgesia provided by locoregional anesthesia (ALR) improves the rehabilitation of patients by reducing the length of hospital stay and morphine consumption. Thus anesthesia of the brachial plexus interscalene (interscalene block or BIS) is considered as the reference technique for the management of post-operative pain after shoulder surgery. It is however provider of hemi-diaphragmatic paralysis (PhD) in nearly 100% of cases. Thus, this technique is usually avoided in patients with respiratory insufficiency. In arthroscopic shoulder surgery, the development of a suprascapular and axillary nerve (SSAX) conjugate block appears to be an effective analgesic alternative in this context.
Detailed description
Two ultrasound-guided approaches of the suprascapular nerve (anterior and posterior approaches) have been described in the literature. From an anatomical point of view, the anterior approach could expose patients to the risk of ipsilateral PhD by phrenic nerve block secondary to diffusion of the local anesthetic into the supraclavicular region.
By measuring the diaphragm excursion during a sniff test, ultrasound allows reliable and reproducible analysis of the diaphragm function.
No study has evaluated the incidence of PhD after ultrasound block of the suprascapular nerve. Knowing the influence of the approach on this complication could be of major interest in this context.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Anterior SSAX | Experimental | Procedure: anterior SSAXpatients receiving suprascapular and axillary nerve block (SSAX) whose approach to the SS nerve is performed by anterior route |
| Posterior SSAX | Experimental | Procedure: posterior SSAXpatients receiving suprascapular and axillary nerve block (SSAX) whose approach to the SS nerve is performed by posterior route |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- to benefit from scheduled arthroscopic surgery of the shoulder under general anesthesia
- Affiliate or beneficiary of a social security scheme
- Having signed the informed consent
Key exclusion criteria (10 listed)
- the existence of contralateral diaphragmatic paralysis
- pre-existing respiratory insufficiency
- impossibility of performing diaphragmatic ultrasound
- the patient's refusal
- the existence of major spontaneous or acquired haemostatic disorders
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 |
|---|---|---|
| anterior SSAXblock of the suprascapular nerve block for shoulder surgery by anterior way | Procedure or surgery | Anterior SSAX |
| posterior SSAXblock of the suprascapular nerve block for shoulder surgery by posterior way | Procedure or surgery | Posterior SSAX |
Primary outcome
change in diaphragmatic excursion
Time frame: 30 minutes
measured on ultrasound between the 30th minute after SSAX and the basal state (i.e. prior to regional anesthesia). The diaphragmatic excursion is the distance traveled by the diaphragm between the functional residual capacity (CRF) and the forced inspiration during a rapid voluntary sniffing (or "sniff test").
1 secondary outcome
PhD over time
Time frame: Baseline, 30 minutes, 4 hours and 8 hours
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 17 Dec 2025.
- Results publication: PubMed 31984478Ferre F, Pommier M, Laumonerie P, Ferrier A, Menut R, Bosch L, Balech V, Bonnevialle N, Minville V. Hemidiaphragmatic paralysis following ultrasound-guided anterior vs. posterior suprascapular nerve block: a double-blind, randomised control trial. Anaesthesia. 2020 Apr;75(4):499-508. doi: 10.1111/anae.14978. Epub 2020 Jan 26.
- Individual participant dataSharing planned: No
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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.
Fabrice FERRE, MD PhD principal investigator
University Hospital, Toulouse
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing anterior SSAX and posterior SSAX in people with Surgery, run by University Hospital, Toulouse at 1 site in France.
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 10 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 17 Dec 2025. 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 France. 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.
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?
change in diaphragmatic excursion (time frame: 30 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03352687, which also lists 1 linked publication.
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 17 Dec 2025.