Ultrasound-Guided Extrafascial Versus Intrafascial Interscalene Brachial Plexus Block in Shoulder Arthroscopy

NCT05222334 | Unknown

• 1 other identifier: 33802/4/20
• Study Type: interventional
• Target: 50
• Locations: 0 countries
• Sites: N/A

Brief Summary

The aim of the study is to compare the diaphragmatic excursion and postoperative analgesia in the extrafascial versus intrafascial Interscalene brachial plexus block in patients undergoing shoulder arthroscopy.

Conditions

Arthroscopy; Analgesia; Intrafascial Interscalene Brachial Plexus Block

Outcome Measures

Primary Outcomes (1)

• Incidence of diaphragmatic excursion reduction after interscalene block

  The diaphragmatic excursion will be measured before the procedure (pre-block), 30 min after the block, and postoperative in Post-Anesthesia Care Unit. Hemidiaphragmatic paresis is defined as hemi-diaphragmatic excursion reduction superior to 75% compared with the pre-procedure value.

  30 min postoperative.

Secondary Outcomes (6)

• Efficacy of block (sensory)

  30 minutes Postoperatively

• Forced expiratory volume in 1 second (FEV 1)

  Intraoperatively or 30 minutes postoperatively

• Pain score using numerical rating scale (NRS)

  24 hours Postoperative

• Total postoperative analgesic consumption

  24 hours Postoperative

• Peak expiratory flow (PEF)

  Intraoperatively or 30 minutes postoperatively

Study Arms (2)

Intrafascial interscalene brachial plexus block group

EXPERIMENTAL

The patients will receive 10 ml of 0.5% bupivacaine for intrafascial interscalene brachial plexus block group

Procedure: Intrafascial interscalene brachial plexus block; Drug: Bupivacaine

Extrafascial interscalene brachial plexus block group

EXPERIMENTAL

The patients will receive 10 ml of 0.5% bupivacaine for extrafascial interscalene brachial plexus block group

Procedure: Extrafascial interscalene brachial plexus block group; Drug: Bupivacaine

Interventions

Intrafascial interscalene brachial plexus block PROCEDURE

After sterilization of skin with povidone-iodine (betadine) and skin infiltration with 1-3ml lidocaine 1%, interscalene brachial plexus block will be performed using an ultrasound machine (Phillips Cx-50,Amsterdam, Netherlands) with a linear probe (L12-3 MHz) will be used in both groups. The US transducer will be placed under aseptic fashion on the lateral side of the neck at the cricoid cartilage level to view three hypoechoic structures, that represent the roots of the brachial plexus. The two outermost nerve roots (C5 and C6) between the anterior and the middle scalene muscles will be identified and the local anesthetic (10 ml 0.5% bupivacaine) is then injected, so that spread will be seen immediately between the C5 and the C6 nerve roots.

Intrafascial interscalene brachial plexus block group

Extrafascial interscalene brachial plexus block group PROCEDURE

Final needle tip position will be 4 mm lateral to the brachial plexus sheath, at a level equidistant between C5 and C6 roots. The distance of 4 mm is chosen according to the calculated success rate over 90% reported. the local anesthetic (10 ml 0.5% bupivacaine) is then injected

Extrafascial interscalene brachial plexus block group

Bupivacaine DRUG

bupivacaine

Extrafascial interscalene brachial plexus block group; Intrafascial interscalene brachial plexus block group

Eligibility Criteria

• Age: 21 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Adult patients of both sexes aged (21-60years) with American Society of Anesthesiologists (ASA) physical status I/II scheduled for shoulder arthroscopy

You may not qualify if:

• Patient refusal.
• Pre-existing (obstructive or restrictive) pulmonary disease.
• Bleeding disorders (coagulopathy).
• Mental dysfunction.
• History of allergy to local anesthetics.
• Pregnancy
• Body mass index (BMI) \>40

Sponsors & Collaborators

• Tanta University: lead

MeSH Terms

Conditions

Agnosia

Interventions

Bupivacaine

Condition Hierarchy (Ancestors)

Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant lecturer

Study Record Dates

• First Submitted: January 24, 2022
• First Posted: February 3, 2022
• Study Start: February 1, 2022
• Primary Completion: February 1, 2023
• Study Completion: February 1, 2023
• Last Updated: February 3, 2022

Record last verified: 2022-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: One year after the end of study