Diaphragmatic Paralysis Comparison Between Local Anesthetic Volumen Doses After Interscalene Block

Study Overview
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Brief Summary
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Arthroscopic shoulder surgery involves dynamic and severe postoperative pain. Interscalene brachial plexus block (IBPB) provides adequate analgesia but the spread of local anaesthetics administered causes a phrenic nerve block which entrains a non-negligible incidence of Hemidiaphragmatic paralysis acute (HDPA). This is a comparative, prospective, Unicenter, double-blind, two-arm, randomized and controlled clinical trial. 48 patients will be included. This RCT would demonstrate a low volume dose IBPB decrease the HDPA after IBPB in patients undergoing SAS, by using spirometry and ultrasound and it will not provide inferior postoperative analgesia according to opioid requirements of postoperative PCA in comparison to standard volume dose used in current practice.

Detailed Description
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Arthroscopic shoulder surgery involves dynamic and severe postoperative pain. Interscalene brachial plexus block (IBPB) provides adequate analgesia but the spread of local anaesthetics administered causes a phrenic nerve block which entrains a non-negligible incidence of Hemidiaphragmatic paralysis acute (HDPA). The primary study objective is to determine the HDPA diagnosed by using diaphragmatic thickness index in Ultrasound (US) after Low Volume (10 mL) versus Standard Volume (20 mL) of Levobupivacaine 0,25% for IBPB. Secondary end-points are 1) HDPA diagnosed by using FVC and FEV1 in spirometry, 2) HDPA diagnosed by using diaphragmatic excursion in US, 3) postoperative pain regarding time to first analgesic consumption and 24-hour cumulative total consumption of Patient-controlled analgesia (PCA) pump of Morphine IV and (4) postoperative harms between two trial-arms. This study is a comparative, prospective, Unicenter, double-blind and two-arm RCT. 48 patients will be included. This RCT would demonstrate a low volume dose IBPB decrease the HDPA after IBPB in patients undergoing SAS, by using spirometry and ultrasound and it will not provide inferior postoperative analgesia according to opioid requirements of postoperative PCA in comparison to standard volume dose used in current practice.

Official Title
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Diaphragmatic Paralysis After Interscalene Brachial Plexus Block: A Randomized, Double-blinded, Unicenter and Controlled Clinical Trial to Reduce the Dose of Levobupivacaine 0,25% 20 ml to 10 ml Undergoing Arthroscopic Shoulder Surgery

Conditions
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Diaphragmatic Paralysis, Brachial Plexus Block

Intervention / Treatment
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* Procedure: Interscalene brachial plexus block
* Drug: Levobupivacaine Hydrochloride 2.5 MG/ML


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients aged 18 to 80 years. ASA I-III. Scheduled for shoulder arthroscopic shoulder surgery and interscalene brachial plexus block. Exclusion Criteria: Age <18 and >80 years. Pregnancy. Exclusión to perform IBPB or spirometry. Allergy to amide group local anaesthetics, opioids or nonsteroidal anti-inflammatory drugs. Background of Pulmonary diseases (chronic obstructive pulmonary disease (COPD) and moderate, severe or not well-controlled asthma), diaphragmatic paralysis or neurological disease with diaphragmatic dysfunction, brachial plexus neuropathy or chronic opioid consumption (more than 3-months consumption or more than oral Morphine 1 mg 1-month). Coagulation disorders (INR>3, TTPA > 35 y AP <50%).

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: The REDOLEV study is a randomized, comparative, prospective, unicenter, double-blind, two-arm and controlled Clinical trial (RCT).
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Standard Volume Dose<br>24 patients will be included in the Standard Volume Dose arm. 20 ml Levobupivacaine Hydrochloride 2.5 MG/ML will be administered in the Interscalene brachial plexus block before the arthroscopic shoulder surgery. | Procedure: Interscalene brachial plexus block<br>* Interscalene brachial plexus block is a locorregional anaesthesia technique which is indicated in shoulder and upper arm surgery. The goal of this block is to place the needle in the tissue space between the anterior and middle scalene muscles and inject local anesthetic until the spread around the brachial plexus is documented by ultrasound.<br>* Other names: Interscalene block;Drug: Levobupivacaine Hydrochloride 2.5 MG/ML<br>* Levobupivacaine Hydrochloride 2.5 MG/ML is an anesthestic product intended for epidural, intradural and perineural administration. Levobupivacaine is chemically described as (S)-l-butyl-2-piperidylformo-2',6'-xylidide hydrochloride. It is a white crystalline powder with a molecular formula of C18H28N2O. HCl, with a molecular weight 324.9. FDA approval: NDA-20997 (1999).<br>* Other names: Chirocaine® 2.5 MG/ML;|
| Experimental: Low Volume Dose<br>24 patients will be included in the Low Volume Dose arm. 10 ml Levobupivacaine Hydrochloride 2.5 MG/ML will be administered in the Interscalene brachial plexus block before the arthroscopic shoulder surgery. | Procedure: Interscalene brachial plexus block<br>* Interscalene brachial plexus block is a locorregional anaesthesia technique which is indicated in shoulder and upper arm surgery. The goal of this block is to place the needle in the tissue space between the anterior and middle scalene muscles and inject local anesthetic until the spread around the brachial plexus is documented by ultrasound.<br>* Other names: Interscalene block;Drug: Levobupivacaine Hydrochloride 2.5 MG/ML<br>* Levobupivacaine Hydrochloride 2.5 MG/ML is an anesthestic product intended for epidural, intradural and perineural administration. Levobupivacaine is chemically described as (S)-l-butyl-2-piperidylformo-2',6'-xylidide hydrochloride. It is a white crystalline powder with a molecular formula of C18H28N2O. HCl, with a molecular weight 324.9. FDA approval: NDA-20997 (1999).<br>* Other names: Chirocaine® 2.5 MG/ML;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from Baseline Diaphragmatic Thickness Ratio at 4 hours | The primary outcome is the difference in the proportion of patients with Hemidiaphragmatic paralysis acute (HDPA) according to diaphragmatic thickness ratio (DTR) in ultrasounds between the Treatment and Control groups. DTR will be the result of Inspiratory Diaphragmatic Thickness and Expiratory Diaphragmatic Thickness. The ratio will be defined by DTR=IDT/EDT. HDPA after IBPB at 4 hours will be diagnosed with a DTR<1.2. | Before (Baseline) and 4-hour after interscalene brachial plexus block | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from Baseline FVC at 4 hours and 24 hours | This secondary outcome is the difference in the proportion of patients with Hemidiaphragmatic paralysis acute (HDPA) according to Forced Vital Capacity (FVC) in spirometry. HDPA will be diagnosed with a CVF diminution of >20%. | Before (Baseline), 4-hour and 24-hour after interscalene brachial plexus block | 
| Change from Baseline FEV1 at 4 hours and 24 hours | This secondary outcome is the difference in the proportion of patients with Hemidiaphragmatic paralysis acute (HDPA) according to forced expiratory volume in one second (FEV1) in spirometry. HDPA will be diagnosed with a FEV1 diminution of >20%. | Before (Baseline), 4-hour and 24-hour after interscalene brachial plexus block | 
| Change from Baseline Diaphragmatic excursion at 4 hours and 24 hours | This secondary outcome is the difference in the proportion of patients with Hemidiaphragmatic paralysis acute (HDPA) according to Diaphragmatic excursion expressed as number of intercostal spaces and motion type. HDPA will be diagnosed with a reduction of >25% number of intercostal spaces or a paradoxal or nule diaphragmatic motion. | Before (Baseline), 4-hour and 24-hour after interscalene brachial plexus block | 
| Postoperative IV morphine consumption | This secondary outcome is the postoperative 24-hour cumulative IV morphine consumption (mg) of Patient controlled analgesia (PCA) pump. | From 4-hour to 24-hour after interscalene brachial plexus block | 
| Postoperative time to first analgesic consumption | This secondary outcome is the time to first analgesic consumption (minutes) of Patient controlled analgesia (PCA) pump. | From 4-hour to 24-hour after interscalene brachial plexus block | 
| Incidence and frequency of Serious Adverse Events (SAE) | This secondary outcome is the incidence, frequency and severity of Serious Adverse Events (SAE) as assessed by CTCAE v4.0 in the two study groups | From performing the interscalene brachial plexus block to finish the 24-hour postoperative follow-up | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Diaphragmatic Paralysis, Interscalene Brachial Plexus Block, Ultrasound, Postoperative pain, Arthroscopic shoulder surgery.