Diaphragmatic Paralysis Comparison Between Local Anesthetic Volumen Doses After Interscalene Block

NCT04385966 | Completed Phase 3 DMC

• 1 other identifier: REDOLEV-2019
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

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.

Conditions

Diaphragmatic Paralysis; Brachial Plexus Block

Keywords

Diaphragmatic Paralysis; Interscalene Brachial Plexus Block; Ultrasound; Postoperative pain; Arthroscopic shoulder surgery.

Outcome Measures

Primary Outcomes (1)

• Change from Baseline Diaphragmatic Thickness Ratio at 4 hours

  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.

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

Secondary Outcomes (6)

• Change from Baseline FVC at 4 hours and 24 hours

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

• Change from Baseline FEV1 at 4 hours and 24 hours

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

• Change from Baseline Diaphragmatic excursion at 4 hours and 24 hours

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

• Postoperative IV morphine consumption

  From 4-hour to 24-hour after interscalene brachial plexus block

• Postoperative time to first analgesic consumption

  From 4-hour to 24-hour after interscalene brachial plexus block

Study Arms (2)

Standard Volume Dose

ACTIVE COMPARATOR

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.

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

Low Volume Dose

EXPERIMENTAL

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.

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

Interventions

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.

Also known as: MeSH Unique ID: D065527, CIE-10 code 3E0T3CZ, Interscalene block

Low Volume Dose; Standard Volume Dose

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).

Also known as: Chirocaine® 2.5 MG/ML

Low Volume Dose; Standard Volume Dose

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients aged 18 to 80 years.
• ASA I-III.
• Scheduled for shoulder arthroscopic shoulder surgery and interscalene brachial plexus block.

You may not qualify if:

• 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%).

Sponsors & Collaborators

• Instituto de Investigación Sanitaria Aragón: lead
• Hospital Miguel Servet: collaborator

Study Sites (1)

Hospital Universitario Miguel Servet

Zaragoza, 50012, Spain

Location

Related Publications (6)

• Lopez Escarraga VM, Dubos Espana K, Castillo Bustos RH, Peidro L, Sastre S, Sala-Blanch X. Diaphragmatic thickness ratio (inspiratory/expiratory) as a diagnostic method of diaphragmatic palsy associated with interescalene block. Rev Esp Anestesiol Reanim (Engl Ed). 2018 Feb;65(2):81-89. doi: 10.1016/j.redar.2017.09.008. Epub 2017 Nov 7. English, Spanish.

  PMID: 29126611 BACKGROUND

• Urmey WF, McDonald M. Hemidiaphragmatic paresis during interscalene brachial plexus block: effects on pulmonary function and chest wall mechanics. Anesth Analg. 1992 Mar;74(3):352-7. doi: 10.1213/00000539-199203000-00006.

  PMID: 1539813 BACKGROUND

• Urmey WF, Talts KH, Sharrock NE. One hundred percent incidence of hemidiaphragmatic paresis associated with interscalene brachial plexus anesthesia as diagnosed by ultrasonography. Anesth Analg. 1991 Apr;72(4):498-503. doi: 10.1213/00000539-199104000-00014.

  PMID: 2006740 BACKGROUND

• Thackeray EM, Swenson JD, Gertsch MC, Phillips KM, Steele JW, Burks RT, Tashjian RZ, Greis PE. Diaphragm function after interscalene brachial plexus block: a double-blind, randomized comparison of 0.25% and 0.125% bupivacaine. J Shoulder Elbow Surg. 2013 Mar;22(3):381-6. doi: 10.1016/j.jse.2012.06.011. Epub 2012 Sep 1.

  PMID: 22947235 BACKGROUND

• Stundner O, Meissnitzer M, Brummett CM, Moser S, Forstner R, Kokofer A, Danninger T, Gerner P, Kirchmair L, Fritsch G. Comparison of tissue distribution, phrenic nerve involvement, and epidural spread in standard- vs low-volume ultrasound-guided interscalene plexus block using contrast magnetic resonance imaging: a randomized, controlled trial. Br J Anaesth. 2016 Mar;116(3):405-12. doi: 10.1093/bja/aev550.

  PMID: 26865133 BACKGROUND

• Oliver-Fornies P, Ortega Lahuerta JP, Gomez Gomez R, Gonzalo Pellicer I, Oliden Gutierrez L, Vinuales Cabeza J, Gallego Ligorit L, Orellana Melgar CE. Diaphragmatic paralysis, respiratory function, and postoperative pain after interscalene brachial plexus block with a reduced dose of 10 ml levobupivacaine 0.25% versus a 20 ml dose in patients undergoing arthroscopic shoulder surgery: study protocol for the randomized controlled double-blind REDOLEV study. Trials. 2021 Apr 19;22(1):287. doi: 10.1186/s13063-021-05216-6.

  PMID: 33874993 DERIVED

MeSH Terms

Conditions

Respiratory Paralysis; Pain, Postoperative

Interventions

Levobupivacaine

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Bupivacaine; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Study Officials

• Pablo O Forniés, MD

  Hospital Miguel Servet

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

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

Study Record Dates

• First Submitted: April 16, 2020
• First Posted: May 13, 2020
• Study Start: February 11, 2020
• Primary Completion: October 20, 2021
• Study Completion: October 20, 2021
• Last Updated: August 12, 2022

Record last verified: 2021-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: Starting in February 2021 for 25 years.
• Access Criteria: * To contact to Study Principal Investigator. * To provide to Study Principal Investigator a request to explain the reason to access to IPD study.

Locations

ES (1)