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Completed

NCT Number: NCT04385966

Diaphragmatic Paralysis Comparison Between Local Anesthetic Volumen Doses After Interscalene Block

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.

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Key information

Conditions

Diaphragmatic Paralysis Brachial Plexus Block Nervous System Diseases Neurologic Manifestations Pain Pain, Postoperative Paralysis Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Respiration Disorders Respiratory Insufficiency Respiratory Paralysis Respiratory Tract Diseases Signs and Symptoms

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Hospital Universitario Miguel Servet

Zaragoza, 50012, Spain

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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%).

Treatment and study plan

Interscalene brachial plexus block

Procedure

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.

Other names: MeSH Unique ID: D065527, CIE-10 code 3E0T3CZ, Interscalene block

Levobupivacaine Hydrochloride 2.5 MG/ML

Drug

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).

Other names: Chirocaine® 2.5 MG/ML

Primary outcomes

  1. Change from Baseline Diaphragmatic Thickness Ratio at 4 hours

    Time frame: Before (Baseline) and 4-hour after interscalene brachial plexus block

    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.

Secondary outcomes

  1. Change from Baseline FVC at 4 hours and 24 hours

    Time frame: Before (Baseline), 4-hour and 24-hour after interscalene brachial plexus block

    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%.

  2. Change from Baseline FEV1 at 4 hours and 24 hours

    Time frame: Before (Baseline), 4-hour and 24-hour after interscalene brachial plexus block

    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%.

  3. Change from Baseline Diaphragmatic excursion at 4 hours and 24 hours

    Time frame: Before (Baseline), 4-hour and 24-hour after interscalene brachial plexus block

    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.

  4. Postoperative IV morphine consumption

    Time frame: From 4-hour to 24-hour after interscalene brachial plexus block

    This secondary outcome is the postoperative 24-hour cumulative IV morphine consumption (mg) of Patient controlled analgesia (PCA) pump.

  5. Postoperative time to first analgesic consumption

    Time frame: From 4-hour to 24-hour after interscalene brachial plexus block

    This secondary outcome is the time to first analgesic consumption (minutes) of Patient controlled analgesia (PCA) pump.

  6. Incidence and frequency of Serious Adverse Events (SAE)

    Time frame: From performing the interscalene brachial plexus block to finish the 24-hour postoperative follow-up

    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

Sponsors and collaborators

Lead sponsor

Instituto de Investigación Sanitaria Aragón

Other

Collaborators

  • Hospital Miguel Servet

Registry information

Official study title

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

Acronym: REDOLEV-2019

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
May 13, 2020
Registry last updated
Aug 12, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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