A Diaphragm-Sparing Nerve Block for Arthroscopic Shoulder Surgery?

NCT03195426 | Completed DMC

• 1 other identifier: 2016-202
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

This study aims at assessing the effectiveness of combined suprascapular nerve block (SSNB), infraclavicular brachial plexus block (ICB) and supraclavicular nerve block (SCNB) as surgical anesthesia for patients scheduled for arthroscopic shoulder surgery. The secondary objective is to test the hypothesis that SSNB-ICB-SCNB combination could spare the phrenic nerve.

Conditions

Regional Anesthesia Morbidity

Outcome Measures

Primary Outcomes (1)

• success of regional anesthesia procedure (no requirement of intraoperative general anethesia)

  The primary outcome is the success rate of regional anesthesia (i.e. intraoperative conversion to general anesthesia was considered as a regional anesthesia failure). General anesthesia was defined as requirement of intraoperative invasive ventilation.

  12 hours

Secondary Outcomes (1)

• diaphragmatic paralysis

  12 hours

Study Arms (1)

distal nerves blocks group

EXPERIMENTAL

This study aims at assessing the effectiveness of combined supra scapular nerve block, infraclavicular block and supraclavicular nerve block as surgical anesthesia for patients scheduled for arthroscopic shoulder surgery. These blocks are performed for decades in routine care. The originality of this study is to analyze the combination of these different blocks for post-operative pain relief in arthroscopic shoulder surgery. This combination can be considered as an alternative to interscalene block well known to be associated with diaphragmatic paralysis. Local anesthetics used in this study are used for many years in routine care: Ropivacaine 0.375%. A single injection will be performed under ultrasounds. No continuous injection will be performed.

Procedure: distal nerves blocks group; Procedure: Diaphragmatic function assessment

Interventions

distal nerves blocks group PROCEDURE

* ICB: US probe will be placed just below clavicle inferior to site of needle entry. Following identification of axillary artery and cords, the needle will be advanced posterior to axillary artery. 20 cc of Ropivacaine 0.375% will then be deposited in a U-shaped distribution posterior and to each side of the axillary artery. * SSNB will be performed by locating the brachial plexus and the departure of the suprascapular nerve from the superior trunk under the inferior belly of the omohyoid muscle by sliding the transducer distally and then injecting 5 mL of ropivacaine 0.375%. * SCNB will be performed injecting 5 mL of ropivacaine 0.375% in the intermuscular plane between the sternocleidomastoid and scalene muscles using a lateral to medial in-plane technique.

distal nerves blocks group

Diaphragmatic function assessment PROCEDURE

Diaphragmatic excursion will be assessed under ultrasound immediately before and after regional anesthesia. This a pain free and safe procedure, that we usually perform in patients at risk of respiratory failure.

distal nerves blocks group

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients undergoing ambulatory arthroscopic shoulder surgery (acromioplasty and supraspinatus tendon repair) will be screened.

Sponsors & Collaborators

• Clinique Medipole Garonne: lead

Study Sites (1)

Clinique Medipole Garonne

Toulouse, 31036, France

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr Marty Philippe

Model Details: This study aims at assessing the effectiveness of combined SSNB, ICB and supraclavicular nerve block (SCNB) as surgical anesthesia for patients scheduled for arthroscopic shoulder surgery. The secondary objective was to test the hypothesis that SSNB-ICB-SCNB combination could spare phrenic nerve.

Study Record Dates

• First Submitted: June 15, 2017
• First Posted: June 22, 2017
• Study Start: June 20, 2017
• Primary Completion: June 22, 2017
• Study Completion: July 10, 2017
• Last Updated: July 13, 2017

Record last verified: 2017-07

Locations

FR (1)