Interscalene Block Versus Superior Trunk Block

Phase 4

Completed

• Conditions: Joint Disease; Pain, Acute; Pain; Pain, Chronic
• Interventions: Drug: Bupivacaine; Device: Ultrasound

• Registration Number: NCT03272139
• Lead Sponsor: Hospital for Special Surgery, New York

Brief Summary

Sparing the phrenic nerve by administering ultrasound-guided low volume superior trunk block (STB) and interscalene block (ISB) for arthroscopic shoulder surgery (labral repair, stabilization, rotator cuff repair).

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2017-08-29
• Study First Submitted QC: 2017-08-31
• Study First Posted: 2017-09-05
• Study Start: 2017-09-28
• Primary Completion: 2018-12-30
• Study Completion: 2019-07-09
• Results First Submitted: 2020-03-12
• Results First Submitted QC: 2020-04-17
• Results First Posted: 2020-04-29
• Status Verified: 2022-04
• Last Update Submitted: 2022-04-19
• Last Update Posted: 2022-05-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 126

Inclusion Criteria

• Patients who will be undergoing primary unilateral labral repair/stabilization of the shoulder
• Age 18 to 80 years
• Planned use of general anesthesia with LMA and interscalene or superior trunk block
• Ability to follow study protocol
• English speaking
• ASA I - III

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Exclusion Criteria

Pre-existing neuropathy of the operative limb

• Younger than 18 years old and older than 80
• Patients with pulmonary severe respiratory disease
• Allergy to one of the study medications
• Chronic gabapentin/pregabalin use (regular use for longer than 3 months)
• Chronic opioid use (taking opioids for longer than 3 months)
• Contraindication to general anesthesia, interscalene or superior trunk block
• Herniated Cervical Disk, Cervical Myelopathy
• BMI >35

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
superior trunk block (STB)	Ultrasound	The superior trunk block will be performed at the point immediately distal to the roots when the c5-c6 form the superior trunk and lies anterior to the middle scalene muscle and below the deep cervical fascia, before the suprascapular nerve arises and goes into the omohyoid. A 22g 1.5-2inch needle will be advanced in-plane from lateral to medial. The needle tip will be placed lateral to the superior trunk and 15 20 ml of 0.5% bupivacaine will be injected just inferior to the deep cervical fasica. Local circumferential spread will be achieved both anterior and posterior to the superior trunk.
interscalene block (ISB)	Ultrasound	The interscalene block will be done using an ultrasound-guided, in-plane approach. The anesthesiologists will target below the C5 nerve root. A 22 gauge 1.5-2 inch needle is advanced in-plane from lateral to medial through the middle scalene muscle until the needle tip is positioned in the interscalene groove between the C5 and C6 nerve roots. 15 20 ml of 0.5% bupivacaine will be injected.
interscalene block (ISB)	Bupivacaine	The interscalene block will be done using an ultrasound-guided, in-plane approach. The anesthesiologists will target below the C5 nerve root. A 22 gauge 1.5-2 inch needle is advanced in-plane from lateral to medial through the middle scalene muscle until the needle tip is positioned in the interscalene groove between the C5 and C6 nerve roots. 15 20 ml of 0.5% bupivacaine will be injected.
superior trunk block (STB)	Bupivacaine	The superior trunk block will be performed at the point immediately distal to the roots when the c5-c6 form the superior trunk and lies anterior to the middle scalene muscle and below the deep cervical fascia, before the suprascapular nerve arises and goes into the omohyoid. A 22g 1.5-2inch needle will be advanced in-plane from lateral to medial. The needle tip will be placed lateral to the superior trunk and 15 20 ml of 0.5% bupivacaine will be injected just inferior to the deep cervical fasica. Local circumferential spread will be achieved both anterior and posterior to the superior trunk.

Primary Outcome Measures

Name	Time	Method
Number of Participants With Incidence of Hemidiaphragmatic Paralysis (HDP)	Day of Surgery, diagnosis confirmed from trained anesthesiologist ultrasound readers	Our primary outcome will be the incidence of hemidiaphragmatic paralysis (HDP) with superior trunk block and interscalene blocks as measured by ultrasound before and after the surgery.
Numerical Pain Rating System (NRS) Pain Scores	Average pain scores at rest recorded Day of Surgery every 30 minutes until discharge according to Post Anaesthetic Discharge Scoring System	Numerical Pain Rating System Pain scores after the superior trunk block and interscalene block at rest measured after the surgery every 30 minute until discharge according to the Post Anaesthetic Discharge Scoring System.; Numerical Rating Scale 0-10; with 0 being no pain and 10 pain as bad as you can imagine.

Secondary Outcome Measures

Name	Time	Method
Block Duration	Time of block wearing off recorded on Post Operative Day 1 and Post Operative Day 2 as reported via patient phone call.	Length of nerve block reported by Phone call on POD 1 and POD 2 by patient phone call

Trial Locations

Locations (1)

Hospital for Special Surgery; 🇺🇸 New York, New York, United States