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

Surgery Clinical Trial

— SSParaDia  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03352687
• Other study ID #: RC31/17/0141
• Secondary ID: 2017-A01378-45
• Status: Completed
• Phase: N/A
• Start date: February 2, 2018
• Est. completion date: February 28, 2019

Study information

• Verified date: April 2019
• Source: University Hospital, Toulouse
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 84
• Est. completion date: February 28, 2019
• Est. primary completion date: January 28, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Paralysis
• Respiratory Paralysis
• Surgery

Intervention

Procedure:
• anterior SSAX
block of the suprascapular nerve block for shoulder surgery by anterior way
• posterior SSAX
block of the suprascapular nerve block for shoulder surgery by posterior way

Locations

Country	Name	City	State
France	University Hospital	Toulouse

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Toulouse

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Pain evaluation by ENS	Evaluation 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	Baseline, 4 hours and 24 hours
Other	Morphine consumption	Evaluation of the morphine consumption in the post-interventional surveillance room (during 24 hours after the SSP)	until 24 hours
Other	patient's satisfaction	Evaluation of the patient's satisfaction with the French Evaluation du Vécu de l'Anesthésie LocoRégionale (EVAN-LR) score	24 hours
Primary	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").	30 minutes
Secondary	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	Baseline, 30 minutes, 4 hours and 8 hours