Different Local Anesthetic Volumes in Brachial Plexus Block

NCT04549779 | Completed

• 1 other identifier: 34017/08/20
• Study Type: interventional
• Target: 91
• Locations: 1 country
• Sites: 1

Brief Summary

This prospective randomized study will be carried out on 75 patients in our university hospitals presented for shoulder arthroscopy under general anesthesia and ultrasound-guided interscalene brachial plexus block. All the patients will receive ultrasound-guided interscalene brachial plexus block with injection of local anesthetic volume according to the group of the patient

• Group I (25 patients): patients will receive 5 ml levobupivacaine 0.25% ISPB
• Group II (25 patients): patients will receive 10 ml levobupivacaine 0.25% ISPB
• Group III (25 patients): patients will receive 15 ml levobupivacaine 0.25% ISPB After ensuring adequate sensory and motor blockade, general anesthesia will be carried out. The primary outcome measurement will be the incidence of diaphragmatic hemiparesis 30 minutes after performing the block detected by US assessment of diaphragmatic excursion and the secondary outcome will be the postoperative pain scores and opioid consumption.

Conditions

Diaphragmatic Disorder

Keywords

Excursion; Diaphragm; Shoulder arthroscope; Postoperative analgesia

Outcome Measures

Primary Outcomes (1)

• The incidence of diaphragmatic hemiparesis 3

  The incidence of diaphragmatic hemiparesis 30 minutes after performing the block detected by US assessment of diaphragmatic excursion

  After 30 minutes of performing the block

Secondary Outcomes (2)

• The postoperative pain scores

  Within the first 24 hours after surgery

• The postoperative opioid consumption

  Within 24 hours after surgery

Study Arms (3)

Group I (low volume)

EXPERIMENTAL

patients will receive 5 ml levobupivacaine 0.25% in ultrasound-guided interscalene brachial plexus block

Procedure: Low volume interscalene brachial plexus block

Group II (intermediate volume)

EXPERIMENTAL

patients will receive 10 ml levobupivacaine 0.25% in ultrasound-guided interscalene brachial plexus block

Procedure: Intermediate volume interscalene brachial plexus block

Group III (high volume)

EXPERIMENTAL

patients will receive 15 ml levobupivacaine 0.25% ultrasound-guided interscalene brachial plexus block.

Procedure: High volume interscalene brachial plexus block

Interventions

Low volume interscalene brachial plexus block PROCEDURE

ultrasound-guided interscalene brachial plexus block with 5 ml levobupivacaine 0.25%

Group I (low volume)

Intermediate volume interscalene brachial plexus block PROCEDURE

ultrasound-guided interscalene brachial plexus block with 10 ml levobupivacaine 0.25%

Group II (intermediate volume)

High volume interscalene brachial plexus block PROCEDURE

ultrasound-guided interscalene brachial plexus block with 15 ml levobupivacaine 0.25%

Group III (high volume)

Eligibility Criteria

• Age: 21 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adult patients of both sexes aged (21-70 years) with ASA physical status I-III scheduled for shoulder surgeries.

You may not qualify if:

• Patients with COPD
• Sever bronchial asthma
• BMI \> 40 kg/m2
• Mental dysfunction
• Allergy to local anesthetics
• Chronic opioid use
• Patients refusal

Sponsors & Collaborators

• Tanta University: lead

Study Sites (1)

Tanta University Hospitals

Tanta, Algharbia Governate, 31511, Egypt

Location

Study Officials

• Sameh Abdelkhalik

  Tanta University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: * The patients will be blinded to their groups. * An anesthesia resident who will not participate in the study and have no subsequent rule in it will help in the preparation of local anesthetic mixtures under strict aseptic precautions. * An assistant nurse who will be blinded to the study groups and will have no subsequent rule in it will help in the collection of the data of measurements.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr

Study Record Dates

• First Submitted: September 9, 2020
• First Posted: September 16, 2020
• Study Start: September 19, 2020
• Primary Completion: August 24, 2021
• Study Completion: August 24, 2022
• Last Updated: June 5, 2023

Record last verified: 2023-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: The data of primary outcome will be available with the corresponding author till 6 months after approval of the publication of the trial.
• Access Criteria: Contact the principle investigator

Locations

EG (1)