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

Not Applicable

• Conditions: Arthroscopy; Intrafascial Interscalene Brachial Plexus Block; Analgesia
• Interventions: Procedure: Intrafascial interscalene brachial plexus block; Procedure: Extrafascial interscalene brachial plexus block group; Drug: Bupivacaine

• Registration Number: NCT05222334
• Lead Sponsor: Tanta University

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2022-01
• Study First Submitted: 2022-01-24
• Study Start: 2022-02-01
• Study First Submitted QC: 2022-02-02
• Last Update Submitted: 2022-02-02
• Study First Posted: 2022-02-03
• Last Update Posted: 2022-02-03
• Primary Completion: 2023-02-01
• Study Completion: 2023-02-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 50

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intrafascial interscalene brachial plexus block group	Intrafascial interscalene brachial plexus block	The patients will receive 10 ml of 0.5% bupivacaine for intrafascial interscalene brachial plexus block group
Extrafascial interscalene brachial plexus block group	Extrafascial interscalene brachial plexus block group	The patients will receive 10 ml of 0.5% bupivacaine for extrafascial interscalene brachial plexus block group
Intrafascial interscalene brachial plexus block group	Bupivacaine	The patients will receive 10 ml of 0.5% bupivacaine for intrafascial interscalene brachial plexus block group
Extrafascial interscalene brachial plexus block group	Bupivacaine	The patients will receive 10 ml of 0.5% bupivacaine for extrafascial interscalene brachial plexus block group

Primary Outcome Measures

Name	Time	Method
Incidence of diaphragmatic excursion reduction after interscalene block	30 min postoperative.	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.

Secondary Outcome Measures

Name	Time	Method
Efficacy of block (sensory)	30 minutes Postoperatively	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.
Forced expiratory volume in 1 second (FEV 1)	Intraoperatively or 30 minutes postoperatively	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
Pain score using numerical rating scale (NRS)	24 hours Postoperative	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
Total postoperative analgesic consumption	24 hours Postoperative	Total consumption of rescue analgesia in form of morphine 0.05 mg/kg/ dose will be recorded
Peak expiratory flow (PEF)	Intraoperatively or 30 minutes postoperatively	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
Efficacy of block (Motor)	30 minutes Postoperatively	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.