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

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.

Study Overview

• Status: Completed
• Conditions: Surgery
• Intervention / Treatment: Procedure: anterior SSAX; Procedure: posterior SSAX

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 Type: Interventional
• Enrollment (Actual): 84
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Toulouse, France, 31000
    • University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Anterior SSAX; patients receiving suprascapular and axillary nerve block (SSAX) whose approach to the SS nerve is performed by anterior route	Procedure: anterior SSAX; block of the suprascapular nerve block for shoulder surgery by anterior way
Experimental: Posterior SSAX; patients receiving suprascapular and axillary nerve block (SSAX) whose approach to the SS nerve is performed by posterior route	Procedure: posterior SSAX; block of the suprascapular nerve block for shoulder surgery by posterior way

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
Morphine consumption	Evaluation of the morphine consumption in the post-interventional surveillance room (during 24 hours after the SSP)	until 24 hours
patient's satisfaction	Evaluation of the patient's satisfaction with the French Evaluation du Vécu de l'Anesthésie LocoRégionale (EVAN-LR) score	24 hours

Collaborators and Investigators

• Sponsor: University Hospital, Toulouse
• Investigators: Principal Investigator: Fabrice FERRE, MD PhD, University Hospital, Toulouse

Study record dates

Study Major Dates

• Study Start (Actual): February 2, 2018
• Primary Completion (Actual): January 28, 2019
• Study Completion (Actual): February 28, 2019

Study Registration Dates

• First Submitted: November 14, 2017
• First Submitted That Met QC Criteria: November 17, 2017
• First Posted (Actual): November 24, 2017

Study Record Updates

• Last Update Posted (Actual): April 26, 2019
• Last Update Submitted That Met QC Criteria: April 25, 2019
• Last Verified: April 1, 2019

More Information

Terms related to this study

• Keywords: Shoulder surgery; Local regional anesthesia
• Additional Relevant MeSH Terms: Nervous System Diseases; Respiratory Tract Diseases; Respiration Disorders; Neurologic Manifestations; Respiratory Insufficiency; Paralysis; Respiratory Paralysis
• Other Study ID Numbers: RC31/17/0141; 2017-A01378-45 (Registry Identifier: ANSM register)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No