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

Perioperative Respiratory and Analgesic Effects of Ultrasound-Guided Extrafascial Versus Intrafascial Interscalene Brachial Plexus Block in Patients Undergoing Shoulder Arthroscopy

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Analgesia; Arthroscopy; Intrafascial Interscalene Brachial Plexus Block
• Intervention / Treatment: Drug: Bupivacaine; Procedure: Intrafascial interscalene brachial plexus block; Procedure: Extrafascial interscalene brachial plexus block group

• Study Type: Interventional
• Enrollment (Anticipated): 50
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years to 60 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

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

Exclusion Criteria:

1. Patient refusal.
2. Pre-existing (obstructive or restrictive) pulmonary disease.
3. Bleeding disorders (coagulopathy).
4. Mental dysfunction.
5. History of allergy to local anesthetics.
6. Pregnancy
7. Body mass index (BMI) >40

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intrafascial interscalene brachial plexus block group; The patients will receive 10 ml of 0.5% bupivacaine for intrafascial interscalene brachial plexus block group	Drug: Bupivacaine; bupivacaine; Procedure: Intrafascial interscalene brachial plexus block; 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.
Experimental: Extrafascial interscalene brachial plexus block group; The patients will receive 10 ml of 0.5% bupivacaine for extrafascial interscalene brachial plexus block group	Drug: Bupivacaine; bupivacaine; Procedure: Extrafascial interscalene brachial plexus block group; 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Efficacy of block (sensory)	The sensory block is assessed by pinprick on a score ranging from 2 to 0 scored as full sensation =2, decreased sensation =1, and loss of sensation to touch or pinprick=0. A successful block is defined as complete sensory (score= 0) in the distribution of the C5 and C6 nerve roots within 30 min of performing the Interscalene Brachial Plexus Block.	30 minutes Postoperatively
Forced expiratory volume in 1 second (FEV 1)	Respiratory related outcome: pulmonary function test including forced expiratory volume in 1 second (FEV 1) will be assessed before block and 30 minutes after discharge to Post-Anesthesia Care Unit (PACU) with a laboratory spirometer (Carevusion Germany Spirometer; Master screen PFT). The best value will be measured and recorded	Intraoperatively or 30 minutes postoperatively
Pain score using numerical rating scale (NRS)	Numerical rating scale (NRS) for assessment of pain intensity (0 = no pain) to (10 = intolerable pain), pain relief is defined as a numerical rating scale of 3 or lower. If the score is >3, the patient will need analgesia in the form of morphine 0.05 mg/kg till it decreases to ≤3. numerical rating scale will be assessed and recorded on arrival to Post-Anesthesia Care Unit (PACU), 1, 2, 4, 8, 12, and 24 hr postoperatively by an anesthesiologist who is blinded to the study groups	24 hours Postoperative
Total postoperative analgesic consumption	Total consumption of rescue analgesia in form of morphine 0.05 mg/kg/ dose will be recorded	24 hours Postoperative
Peak expiratory flow (PEF)	Peak expiratory flow (PEF) will be assessed before block and 30 minutes after discharge to Post-Anesthesia Care Unit (PACU) with a laboratory spirometer (Carevusion Germany Spirometer; Master screen PFT). The best value will be measured and recorded	Intraoperatively or 30 minutes postoperatively
Efficacy of block (Motor)	Motor assessment will be tested by using arm abduction (C5), and forearm flexion (C6) (incapacity to overcome gravity= 0; reduced force compared with contralateral arm =1, no loss of force =2). A successful block is defined as motor (score,=0) block in the distribution of the C5 and C6 nerve roots within 30 min of performing the Interscalene Brachial Plexus Block.	30 minutes Postoperatively

Collaborators and Investigators

• Sponsor: Tanta University

Study record dates

Study Major Dates

• Study Start (Anticipated): February 1, 2022
• Primary Completion (Anticipated): February 1, 2023
• Study Completion (Anticipated): February 1, 2023

Study Registration Dates

• First Submitted: January 24, 2022
• First Submitted That Met QC Criteria: February 2, 2022
• First Posted (Actual): February 3, 2022

Study Record Updates

• Last Update Posted (Actual): February 3, 2022
• Last Update Submitted That Met QC Criteria: February 2, 2022
• Last Verified: January 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Sensory System Agents; Anesthetics; Anesthetics, Local; Bupivacaine
• Other Study ID Numbers: 33802/4/20

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes
• IPD Plan Description: The data will be available upon any reasonable request
• IPD Sharing Time Frame: One year after the end of study
• IPD Sharing Supporting Information Type: Study Protocol

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No