Interscalene Block and Dysfunction Diaphragmatic

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Diaphragmatic Paralysis

Intervention / Treatment
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* Drug: Ropivacaine 0.5% Injectable Solution
* Drug: Ropivacaine 0.1% Injectable Solution


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Experimental group : ropivacaine 0.1%<br>Interscalene block for arthroscopic shoulder surgery with small volume of low concentration (0.1%) of ropivacaine | Drug: Ropivacaine 0.1% Injectable Solution<br>* Dilution of ropivacaine to the concentration of 0.1%<br>* Other names: Naropeine 0.1%;|
| Active Comparator: control group : ropivacaine 0.5%<br>Interscalene block for arthroscopic shoulder surgery with small volume of standard concentration (0.5%) of ropivacaine | Drug: Ropivacaine 0.5% Injectable Solution<br>* Injectable solution of ropivacaine 0.5%<br>* Other names: naropeine 0.5%;|

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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interscalene block, shoulder surgery, local anesthesic, respiratory function, diaphragmatic dysfunction, echography, locoregional anesthesia