Interscalene Block and Dysfunction Diaphragmatic (NUMEROBIS)

Interscalene Block and Dysfunction Diaphragmatic: Effect of Low Volume of Ropivacaine 0,1%. A Randomised, Controlled Trial

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.

Study Overview

• Status: Completed
• Conditions: Diaphragmatic Paralysis
• Intervention / Treatment: Drug: Ropivacaine 0.1% Injectable Solution; Drug: Ropivacaine 0.5% Injectable Solution

Detailed Description

It's a prospective monocentric randomized controlled clinical trial in 2 parallel groups in double blind.

the study concerns patients undergoing arthroscopic shoulder surgery with ISB. 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.

Randomization in one of the two arms:

• Experimental group: <8ml ropivacaine 0.1%.
• Control group: <8mL of ropivacaine 0.5%.

Evaluation of diaphragmatic stroke by ultrasound and ventilatory function by spirometry and snip test before performing the ISB, then after installation of the ISB.

Performing the surgical procedure under general anesthesia assessment of postoperative analgesia and patient satisfaction during the following 48 hours.

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Phase 3

Contacts and Locations

Study Locations

• France
  • Lille, France
    • Hôpital Roger Salengro, CHU

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

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

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: DOUBLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Experimental group : ropivacaine 0.1%; Interscalene block for arthroscopic shoulder surgery with small volume of low concentration (0.1%) of ropivacaine	Drug: Ropivacaine 0.1% Injectable Solution; Dilution of ropivacaine to the concentration of 0.1%; Other Names: Naropeine 0.1%
ACTIVE_COMPARATOR: control group : ropivacaine 0.5%; Interscalene block for arthroscopic shoulder surgery with small volume of standard concentration (0.5%) of ropivacaine	Drug: Ropivacaine 0.5% Injectable Solution; Injectable solution of ropivacaine 0.5%; Other Names: naropeine 0.5%

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Compare the frequency of hemi-diaphragmatic paralysis	Hemi-diaphragmatic paralysis refers to the absence of diaphragmatic movement (or paradoxical movement) in ultrasound during rest ventilation and slow, deep inhalation.	1h after interscalene block
Compare intraoperative analgesia	Total consumption of sufentanil, and Analgesia Nociception Index values (ANI, MetroDoloris, France).	peroperative time
Compare postoperative analgesia	Duration of effective analgesia (defined as the period up to the first EVA > 3 (excluding PACU Consumption of morphine in PACU and analgesics within the first 24 hours.	24 hours postoperatively
Compare the ventilatory function (spirometry and snip test).	Presence of a respiratory impairment detected by spirometry (Spiro-USB® device) and presence of a diaphragmatic impairment detected by snip test, (micro-RPM®). Ventilation impairment will be considered present if there is a decrease of at least 25% in vital capacity between the pre and post ISB. Diaphragmatic damage is defined as a decrease of at least 25% in the Snip-test values between the pre and post ISB.	1h after interscalene block
Compare patient satisfaction	Evaluation of patient satisfaction by questionnaire at the patient's bedside or by telephone call within 24h-48h postoperatively. It is assessed on a numerical scale from 0 to 10 (0 being the lowest satisfaction value and 10 the highest value)	24 to 48 hours postoperatively
Compare the contralateral diaphragmatic stroke	Evaluation of contralateral diaphragmatic compensation (diaphragmatic stroke in ultrasound, comparison of post-ISB time vs. pre-ISB time, expressed in %).	1h after interscalene block

Collaborators and Investigators

• Sponsor: University Hospital, Lille
• Investigators: Principal Investigator: Arnaud ALLUIN, MD, University Hospital, Lille

Study record dates

Study Major Dates

• Study Start (ACTUAL): October 29, 2019
• Primary Completion (ACTUAL): September 21, 2020
• Study Completion (ACTUAL): September 21, 2020

Study Registration Dates

• First Submitted: November 20, 2019
• First Submitted That Met QC Criteria: November 20, 2019
• First Posted (ACTUAL): November 21, 2019

Study Record Updates

• Last Update Posted (ACTUAL): June 21, 2022
• Last Update Submitted That Met QC Criteria: June 17, 2022
• Last Verified: June 1, 2022

More Information

Terms related to this study

• Keywords: echography; respiratory function; locoregional anesthesia; shoulder surgery; interscalene block; diaphragmatic dysfunction; local anesthesic
• Additional Relevant MeSH Terms: Nervous System Diseases; Respiratory Tract Diseases; Respiration Disorders; Neurologic Manifestations; Respiratory Insufficiency; Paralysis; Respiratory Paralysis; Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Sensory System Agents; Anesthetics; Anesthetics, Local; Pharmaceutical Solutions; Ropivacaine
• Other Study ID Numbers: 2018_66; 2019-001984-62 (EUDRACT_NUMBER)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No