Diaphragmatic Paralysis Comparison Between Local Anesthetic Volumen Doses After Interscalene Block

Phase 3

Completed

• Conditions: Brachial Plexus Block; Diaphragmatic Paralysis
• Interventions: Procedure: Interscalene brachial plexus block; Drug: Levobupivacaine Hydrochloride 2.5 MG/ML

• Registration Number: NCT04385966
• Lead Sponsor: Instituto de Investigación Sanitaria Aragón

Brief Summary

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

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.

Study Timeline

• Study Start: 2020-02-11
• Study First Submitted: 2020-04-16
• Study First Submitted QC: 2020-05-08
• Study First Posted: 2020-05-13
• Status Verified: 2021-08
• Primary Completion: 2021-10-20
• Study Completion: 2021-10-20
• Last Update Submitted: 2022-08-09
• Last Update Posted: 2022-08-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 48

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%).

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Standard Volume Dose	Levobupivacaine Hydrochloride 2.5 MG/ML	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.
Low Volume Dose	Levobupivacaine Hydrochloride 2.5 MG/ML	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.
Standard Volume Dose	Interscalene brachial plexus block	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.
Low Volume Dose	Interscalene brachial plexus block	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.

Primary Outcome Measures

Name	Time	Method
Change from Baseline Diaphragmatic Thickness Ratio at 4 hours	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 Outcome Measures

Name	Time	Method
Change from Baseline FEV1 at 4 hours and 24 hours	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%.
Incidence and frequency of Serious Adverse Events (SAE)	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
Change from Baseline FVC at 4 hours and 24 hours	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%.
Change from Baseline Diaphragmatic excursion at 4 hours and 24 hours	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.
Postoperative time to first analgesic consumption	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.
Postoperative IV morphine consumption	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.

Trial Locations

Locations (1)

Hospital Universitario Miguel Servet; 🇪🇸 Zaragoza, Spain