Diaphragmatic Paralysis Comparison Between Local Anesthetic Volumen Doses After Interscalene Block

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

48 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-02-11

Study Completion Date

2021-10-20

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.

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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.

Conditions

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Diaphragmatic Paralysis Brachial Plexus Block

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

The REDOLEV study is a randomized, comparative, prospective, unicenter, double-blind, two-arm and controlled Clinical trial (RCT).

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

After randomization, only Interscalene Block performer staff will know which intervention group is assigned to the participants. Spirometry and ultrasound assessments will be conducted by only one blinded anesthesiologist of Assessment staff who will not be communicated to IBPB staff. Recruitment and Assessment staff and participants will not be allowed to receive any information about the group allocation. Study unblinding will occur when every ultrasound and Spirometry assessments have been completed after 24-hour follow-up postoperative closeout. After follow-up finished, every study data will figure in the patient medical record. Code breaks should occur only in exceptional circumstances when knowledge of the actual treatment is absolutely essential for further management of the patient as an allergy episode. The Research staff will be encouraged to maintain the blind as far as possible. Unblinded IBPB staff will manage the emergency.

Study Groups

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Standard Volume Dose

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.

Group Type ACTIVE_COMPARATOR

Interscalene brachial plexus block

Intervention Type 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.

Levobupivacaine Hydrochloride 2.5 MG/ML

Intervention Type 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).

Low Volume Dose

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.

Group Type EXPERIMENTAL

Interscalene brachial plexus block

Intervention Type 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.

Levobupivacaine Hydrochloride 2.5 MG/ML

Intervention Type 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).

Interventions

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Interscalene brachial plexus block

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.

Intervention Type PROCEDURE

Levobupivacaine Hydrochloride 2.5 MG/ML

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).

Intervention Type DRUG

Other Intervention Names

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MeSH Unique ID: D065527 CIE-10 code 3E0T3CZ Interscalene block Chirocaine® 2.5 MG/ML

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%).

Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes