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

Sponsor
University Hospital, Toulouse (Other)
Overall Status
Completed
CT.gov ID
NCT03352687
Collaborator
(none)
84
1
2
12.8
6.5

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Procedure: anterior SSAX
  • Procedure: posterior SSAX
N/A

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

Study Type:
Interventional
Actual Enrollment :
84 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Diaphragmatic Paralysis After Ultrasound Block of the Suprascapular Nerve for Shoulder Surgery : Incidence and Influence of the Approach
Actual Study Start Date :
Feb 2, 2018
Actual Primary Completion Date :
Jan 28, 2019
Actual Study Completion Date :
Feb 28, 2019

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

  1. change in diaphragmatic excursion [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").

Secondary Outcome Measures

  1. PhD over time [Baseline, 30 minutes, 4 hours and 8 hours]

    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

Other Outcome Measures

  1. Pain evaluation by ENS [Baseline, 4 hours and 24 hours]

    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

  2. Morphine consumption [until 24 hours]

    Evaluation of the morphine consumption in the post-interventional surveillance room (during 24 hours after the SSP)

  3. patient's satisfaction [24 hours]

    Evaluation of the patient's satisfaction with the French Evaluation du Vécu de l'Anesthésie LocoRégionale (EVAN-LR) score

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts 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

Contacts and Locations

Locations

Site City State Country Postal Code
1 University Hospital Toulouse France 31000

Sponsors and Collaborators

  • University Hospital, Toulouse

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
University Hospital, Toulouse
ClinicalTrials.gov Identifier:
NCT03352687
Other Study ID Numbers:
  • RC31/17/0141
  • 2017-A01378-45
First Posted:
Nov 24, 2017
Last Update Posted:
Apr 26, 2019
Last Verified:
Apr 1, 2019
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by University Hospital, Toulouse
Additional relevant MeSH terms:

Study Results

No Results Posted as of Apr 26, 2019