Interscalene Block and Dysfunction Diaphragmatic

NCT04173364 | Completed Phase 3

• 2 other identifiers: 2018_662019-001984-62
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

The study seeks to show that interscalene injection of a small volume (\<8ml) of ropivacaine at a low concentration (0.1%) reduces the frequency of hemi-diaphragmatic paresis compared to low volume injection at the standard concentration (0.5%) in patients undergoing arthroscopic shoulder surgery with ISB.

Conditions

Diaphragmatic Paralysis

Keywords

interscalene block; shoulder surgery; local anesthesic; respiratory function; diaphragmatic dysfunction; echography; locoregional anesthesia

Outcome Measures

Primary Outcomes (1)

• Compare the occurrence of hemi-diaphragmatic paresis

  Hemi diaphragmatic paresis is evaluated by quantifying the homolateral diaphragmatic stroke at interscalene block (ISB) by ultrasound analysis (measured in centimeter), during slow and deep inspiration. Diaphragmatic hemiparesis is defined as a decrease (at post-ISB time vs. pre-ISB time) of more than 25% of the diaphragmatic stroke during this slow and deep inspiration.

  1h after interscalene block

Secondary Outcomes (6)

• Compare the frequency of hemi-diaphragmatic paralysis

  1h after interscalene block

• Compare intraoperative analgesia

  peroperative time

• Compare postoperative analgesia

  24 hours postoperatively

• Compare the ventilatory function (spirometry and snip test).

  1h after interscalene block

• Compare patient satisfaction

  24 to 48 hours postoperatively

Study Arms (2)

Experimental group : ropivacaine 0.1%

EXPERIMENTAL

Interscalene block for arthroscopic shoulder surgery with small volume of low concentration (0.1%) of ropivacaine

Drug: Ropivacaine 0.1% Injectable Solution

control group : ropivacaine 0.5%

ACTIVE COMPARATOR

Interscalene block for arthroscopic shoulder surgery with small volume of standard concentration (0.5%) of ropivacaine

Drug: Ropivacaine 0.5% Injectable Solution

Interventions

Ropivacaine 0.5% Injectable Solution DRUG

Injectable solution of ropivacaine 0.5%

Also known as: naropeine 0.5%

control group : ropivacaine 0.5%

Ropivacaine 0.1% Injectable Solution DRUG

Dilution of ropivacaine to the concentration of 0.1%

Also known as: Naropeine 0.1%

Experimental group : ropivacaine 0.1%

Eligibility Criteria

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

You may qualify if:

• orthopedic surgery compatible with interscalene block
• french speaking
• Patient who signed consent to participate in the study

You may not qualify if:

• Pregnant woman
• ASA score \> 3
• Severe chronic respiratory insufficiency
• COPD \>3 or 4 of Gold score
• coagulation trouble
• Allergic to medication involved in the study
• Breastfeeding women

Sponsors & Collaborators

• University Hospital, Lille: lead

Study Sites (1)

Hôpital Roger Salengro, CHU

Lille, France

Location

MeSH Terms

Conditions

Respiratory Paralysis; Respiratory Aspiration

Interventions

Ropivacaine

Condition Hierarchy (Ancestors)

Respiratory Insufficiency; Respiration Disorders; Respiratory Tract Diseases; Paralysis; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Pathologic Processes

Intervention Hierarchy (Ancestors)

Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Study Officials

• Arnaud ALLUIN, MD

  University Hospital, Lille

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 20, 2019
• First Posted: November 21, 2019
• Study Start: October 29, 2019
• Primary Completion: September 21, 2020
• Study Completion: September 21, 2020
• Last Updated: June 21, 2022

Record last verified: 2022-06

Locations

FR (1)