Diaphragmatic Paralysis After Ultrasound Block of the Suprascapular Nerve for Shoulder Surgery (SSParaDia)
Primary Purpose
Surgery
Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
anterior SSAX
posterior SSAX
Sponsored by
About this trial
This is an interventional treatment trial for Surgery focused on measuring Shoulder surgery, Local regional anesthesia
Eligibility Criteria
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
Sites / Locations
- University Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Anterior SSAX
Posterior SSAX
Arm Description
patients receiving suprascapular and axillary nerve block (SSAX) whose approach to the SS nerve is performed by anterior route
patients receiving suprascapular and axillary nerve block (SSAX) whose approach to the SS nerve is performed by posterior route
Outcomes
Primary Outcome Measures
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").
Secondary Outcome Measures
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
Full Information
NCT ID
NCT03352687
First Posted
November 14, 2017
Last Updated
April 25, 2019
Sponsor
University Hospital, Toulouse
1. Study Identification
Unique Protocol Identification Number
NCT03352687
Brief Title
Diaphragmatic Paralysis After Ultrasound Block of the Suprascapular Nerve for Shoulder Surgery
Acronym
SSParaDia
Official Title
Diaphragmatic Paralysis After Ultrasound Block of the Suprascapular Nerve for Shoulder Surgery : Incidence and Influence of the Approach
Study Type
Interventional
2. Study Status
Record Verification Date
April 2019
Overall Recruitment Status
Completed
Study Start Date
February 2, 2018 (Actual)
Primary Completion Date
January 28, 2019 (Actual)
Study Completion Date
February 28, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Toulouse
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Surgery
Keywords
Shoulder surgery, Local regional anesthesia
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
84 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Anterior SSAX
Arm Type
Experimental
Arm Description
patients receiving suprascapular and axillary nerve block (SSAX) whose approach to the SS nerve is performed by anterior route
Arm Title
Posterior SSAX
Arm Type
Experimental
Arm Description
patients receiving suprascapular and axillary nerve block (SSAX) whose approach to the SS nerve is performed by posterior route
Intervention Type
Procedure
Intervention Name(s)
anterior SSAX
Intervention Description
block of the suprascapular nerve block for shoulder surgery by anterior way
Intervention Type
Procedure
Intervention Name(s)
posterior SSAX
Intervention Description
block of the suprascapular nerve block for shoulder surgery by posterior way
Primary Outcome Measure Information:
Title
change in diaphragmatic excursion
Description
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").
Time Frame
30 minutes
Secondary Outcome Measure Information:
Title
PhD over time
Description
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
Time Frame
Baseline, 30 minutes, 4 hours and 8 hours
Other Pre-specified Outcome Measures:
Title
Pain evaluation by ENS
Description
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
Time Frame
Baseline, 4 hours and 24 hours
Title
Morphine consumption
Description
Evaluation of the morphine consumption in the post-interventional surveillance room (during 24 hours after the SSP)
Time Frame
until 24 hours
Title
patient's satisfaction
Description
Evaluation of the patient's satisfaction with the French Evaluation du Vécu de l'Anesthésie LocoRégionale (EVAN-LR) score
Time Frame
24 hours
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Fabrice FERRE, MD PhD
Organizational Affiliation
University Hospital, Toulouse
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Hospital
City
Toulouse
ZIP/Postal Code
31000
Country
France
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Diaphragmatic Paralysis After Ultrasound Block of the Suprascapular Nerve for Shoulder Surgery
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