Diaphragmatic Paralysis Comparison Between Local Anesthetic Volumen Doses After Interscalene Block (REDOLEV-2019)

Instituto de Investigación Sanitaria Aragón

Status and phase: Completed; Phase 3

Conditions: Brachial Plexus Block; Diaphragmatic Paralysis

Treatments: Drug: Levobupivacaine Hydrochloride 2.5 MG/ML; Procedure: Interscalene brachial plexus block

Study type: Interventional

Funder types: Other

Identifiers

NCT04385966

REDOLEV-2019

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 48 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: Accepts Healthy Volunteers

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%).

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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48 participants in 2 patient groups

Standard Volume Dose

Active Comparator group

Description:

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.

Treatment:

Procedure: Interscalene brachial plexus block

Drug: Levobupivacaine Hydrochloride 2.5 MG/ML

Low Volume Dose

Experimental group

Description:

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.

Treatment:

Procedure: Interscalene brachial plexus block

Drug: Levobupivacaine Hydrochloride 2.5 MG/ML