Interscalene Block Versus Superior Trunk Block

NCT ID: NCT03272139

Last Updated: 2022-05-11

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 126 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-09-28
• Study Completion Date: 2019-07-09

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).

Conditions

Joint Disease; Pain; Pain, Acute; Pain, Chronic

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

interscalene block (ISB)

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.

Group Type: EXPERIMENTAL

Bupivacaine

Intervention Type: DRUG

Anesthetic that will help treat pain and sensation after shoulder arthroscopy

Ultrasound

Intervention Type: DEVICE

Ultrasound will help guide the anesthesiologist in performing the different nerve blocks

superior trunk block (STB)

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.

Group Type: EXPERIMENTAL

Bupivacaine

Intervention Type: DRUG

Anesthetic that will help treat pain and sensation after shoulder arthroscopy

Ultrasound

Intervention Type: DEVICE

Ultrasound will help guide the anesthesiologist in performing the different nerve blocks

Interventions

Bupivacaine

Anesthetic that will help treat pain and sensation after shoulder arthroscopy

Intervention Type: DRUG

Ultrasound

Ultrasound will help guide the anesthesiologist in performing the different nerve blocks

Intervention Type: DEVICE

Eligibility Criteria

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

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hospital for Special Surgery, New York

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

David H Kim, MD

Role: PRINCIPAL_INVESTIGATOR

Hospital for Special Surgery, New York

Locations

Hospital for Special Surgery

New York, New York, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

2017-0979

Identifier Type: -

Identifier Source: org_study_id