Hemidiaphragmatic Paralysis With Diluted Continuous Interscalene Plexus Infusions

Study Overview
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Brief Summary
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Interscalene brachial plexus block (ISB) constitutes the analgesic criterion standard for shoulder surgery. However, it is associated with a high incidence of hemidiaphragmatic paralysis (HDP) that may not be tolerated by patients with chronic pulmonary disease. Continuous ISBs have not avoided this complication with the reported and regularly used local anesthetic dilutions (i.e. 0.125% bupivacaine, 0.25% ropivacaine, etc). This observational study will register the incidence of HDP in continuous interscalene block (CISB) using a very diluted solution of levobupivacaine (0.04%) in patients undergoing arthroscopic shoulder surgery. The main objective of this study is to determine the frequency of HDP the first postoperative day before patient discharge(POD).

Official Title
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Incidence of Hemidiaphragmatic Paralysis Using 0.04% Levobupivacaine for Continuous Interscalene Brachial Plexus Blocks in Arthroscopic Shoulder Surgeries

Conditions
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Diaphragmatic Paralysis, Postoperative Pain, Acute Pain, Shoulder Pain, Shoulder Injury

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: age between 18 and 80 years American Society of Anesthesiologists classification 1-3 body mass index between 20 and 35 Exclusion Criteria: adults who are unable to give their own consent pre-existing neuropathy (assessed by history and physical examination) coagulopathy (assessed by history and physical examination and, if deemed clinically necessary, by blood work up i.e. platelets ≤ 100, International Normalized Ratio ≥ 1.4 or prothrombin time ≥ 50) renal failure (assessed by history and physical examination and, if deemed clinically necessary, by blood work up i.e. creatinine ≥ 100) hepatic failure (assessed by history and physical examination and, if deemed clinically necessary, by blood work up i.e. transaminases ≥ 100) allergy to local anesthetics (LAs) pregnancy prior surgery in the ipsilateral neck region chronic pain conditions

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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No

Study Plan
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How is the study designed?
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What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hemidiaphragmatic paralysis before discharge | Defined as less than 25% of basal diaphragm excursion evaluated with ultrasonography | 24 hours after surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hemidiaphragmatic paralysis after surgery | Defined as less than 25% of basal diaphragm excursion evaluated with ultrasonography | 30 minutes after arrival to post anesthetic care unit (PACU) | 
| Amount of local anesthetic (LA) boluses used before discharge. | boluses of LA administered by the patient controlled infusor in adidiotn to a basal rate. | 24 hours after surgery | 
| Level of static postoperative pain at 30 minutes of arrival to PACU | level of pain at rest referred by the patient using a numeric rating scale from 0 to 10 | 30 minutes after arrival to PACU | 
| Level of static postoperative pain 1 hour after arrival to PACU | level of pain at rest referred by the patient using a numeric rating scale from 0 to 10 | 60 minutes after arrival | 
| Level of static postoperative pain 3 hour after arrival to PACU | level of pain at rest referred by the patient using a numeric rating scale from 0 to 10 | 3 hours after arrival to PACU | 
| level of static pain 6 hours after arrival to PACU | level of pain at rest referred by the patient using a numeric rating scale from 0 to 10 | 6 hours after arrival to PACU | 
| Level of static pain 12 hours after arrival to PACU | Level of pain at rest referred by the patient using a numeric rating scale from 0 to 10 | 12 hour after arrival to PACU | 
| Level of static pain before discharge | Level of pain at rest referred by the patient using a numeric rating scale from 0 to 10 | 24 hours post surgery | 
| Level of static pain during first day after the day of discharge | Level of pain at rest referred by the patient using a numeric rating scale from 0 to 10 | 48 hours after surgery | 
| Level of static pain during second day after the day of discharge | Level of pain at rest referred by the patient using a numeric rating scale from 0 to 10 | 72 hours after surgery | 
| intraoperative morphine equivalent consumption | total amount of morphine equivalent opioid requirement in milligrams | intraoperative period | 
| postoperative morphine equivalent consumption | total amount of morphine equivalent opioid requirement in milligrams | 24 hours after surgery | 
| sensory block in PACU | loss of sensation to cold in lateral deltoid area | 30 minutes after arrival to PACU | 
| Motor block in PACU | paresia or paralysis in operated side, shoulder, arm, forearm or hand | 30 minutes after arrival to PACU | 
| sensory block previous to discharge | loss of sensation to cold in lateral deltoid area | 24 hours after surgery | 
| motor block previous to discharge | paresia or paralysis in operated side shoulder, arm, forearm or hand | 24 hours after surgery | 
| Incidence of side effects before discharge | presence of side effects (vascular puncture, Horner syndrome, hoarseness, LA systemic toxicity, catheter dislodgement, catheter insertion site leak), related with the block. | 24 hours after surgery | 
| incidence of side effects after discharge with ambulatory continuous ISB. | presence of side effects (vascular puncture, Horner syndrome, hoarseness, LA systemic toxicity, catheter dislodgement, catheter insertion site leak), related with the block. | 24 to 72 hours after surgery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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hemidiaphragmatic paralysis, continuous plexus block, interscalene plexus block, diluted local anesthetic infusion, ambulatory regional analgesia, ambulatory continuous nerve block, continuous local anesthetic infusion