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Diaphragmatic Paralysis After Ultrasound Block of the Suprascapular Nerve for Shoulder Surgery

Diaphragmatic Paralysis After Ultrasound Block of the Suprascapular Nerve for Shoulder Surgery : Incidence and Influence of the Approach

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03352687
Acronym
SSParaDia
Enrollment
84
Registered
2017-11-24
Start date
2018-02-02
Completion date
2019-02-28
Last updated
2025-12-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Surgery

Keywords

Shoulder surgery, Local regional anesthesia

Brief 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. 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.

Interventions

PROCEDUREanterior SSAX

block of the suprascapular nerve block for shoulder surgery by anterior way

PROCEDUREposterior SSAX

block of the suprascapular nerve block for shoulder surgery by posterior way

Sponsors

University Hospital, Toulouse
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* 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

Exclusion criteria

* 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 * 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

Design outcomes

Primary

MeasureTime frameDescription
change in diaphragmatic excursion30 minutesmeasured 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).

Secondary

MeasureTime frameDescription
PhD over timeBaseline, 30 minutes, 4 hours and 8 hoursdiaphragmatic 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

Other

MeasureTime frameDescription
Pain evaluation by ENSBaseline, 4 hours and 24 hoursEvaluation of the pain by simple numerical scale (ENS from 0 to 10) in the post-interventional surveillance room (SSPI, at the 4th hour) and at the 24th hour
Morphine consumptionuntil 24 hoursEvaluation of the morphine consumption in the post-interventional surveillance room (during 24 hours after the SSP)
patient's satisfaction24 hoursEvaluation of the patient's satisfaction with the French Evaluation du Vécu de l'Anesthésie LocoRégionale (EVAN-LR) score

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026