NCT03352687

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
84

participants targeted

Target at P25-P50 for not_applicable surgery

Timeline
Completed

Started Feb 2018

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 14, 2017

Completed
10 days until next milestone

First Posted

Study publicly available on registry

November 24, 2017

Completed
2 months until next milestone

Study Start

First participant enrolled

February 2, 2018

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 28, 2019

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

February 28, 2019

Completed
Last Updated

December 17, 2025

Status Verified

April 1, 2019

Enrollment Period

12 months

First QC Date

November 14, 2017

Last Update Submit

December 9, 2025

Conditions

Surgery

Keywords

Shoulder surgeryLocal regional anesthesia

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • PhD over time

    Baseline, 30 minutes, 4 hours and 8 hours

Other Outcomes (3)

  • Pain evaluation by ENS

    Baseline, 4 hours and 24 hours

  • Morphine consumption

    until 24 hours

  • patient's satisfaction

    24 hours

Study Arms (2)

Anterior SSAX

EXPERIMENTAL

patients receiving suprascapular and axillary nerve block (SSAX) whose approach to the SS nerve is performed by anterior route

Procedure: anterior SSAX

Posterior SSAX

EXPERIMENTAL

patients receiving suprascapular and axillary nerve block (SSAX) whose approach to the SS nerve is performed by posterior route

Procedure: posterior SSAX

Interventions

anterior SSAXPROCEDURE

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

Anterior SSAX
posterior SSAXPROCEDURE

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

Posterior SSAX

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital

Toulouse, 31000, France

Location

Related Publications (1)

  • Ferre F, Pommier M, Laumonerie P, Ferrier A, Menut R, Bosch L, Balech V, Bonnevialle N, Minville V. Hemidiaphragmatic paralysis following ultrasound-guided anterior vs. posterior suprascapular nerve block: a double-blind, randomised control trial. Anaesthesia. 2020 Apr;75(4):499-508. doi: 10.1111/anae.14978. Epub 2020 Jan 26.

    PMID: 31984478RESULT

Study Officials

  • Fabrice FERRE, MD PhD

    University Hospital, Toulouse

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 14, 2017

First Posted

November 24, 2017

Study Start

February 2, 2018

Primary Completion

January 28, 2019

Study Completion

February 28, 2019

Last Updated

December 17, 2025

Record last verified: 2019-04

Data Sharing

IPD Sharing
Will not share

Locations

FR(1)