Interscalene Block Versus Superior Trunk Block

NCT03272139 | Completed Phase 4 Results FDA Drug

• 1 other identifier: 2017-0979
• Study Type: interventional
• Target: 126
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (2)

• Number of Participants With Incidence of Hemidiaphragmatic Paralysis (HDP)

  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.

  Day of Surgery, diagnosis confirmed from trained anesthesiologist ultrasound readers

• Numerical Pain Rating System (NRS) Pain Scores

  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.

  Average pain scores at rest recorded Day of Surgery every 30 minutes until discharge according to Post Anaesthetic Discharge Scoring System

Secondary Outcomes (1)

• Block Duration

  Time of block wearing off recorded on Post Operative Day 1 and Post Operative Day 2 as reported via patient phone call.

Study Arms (2)

interscalene block (ISB)

EXPERIMENTAL

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.

Drug: Bupivacaine; Device: Ultrasound

superior trunk block (STB)

EXPERIMENTAL

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.

Drug: Bupivacaine; Device: Ultrasound

Interventions

Bupivacaine DRUG

Anesthetic that will help treat pain and sensation after shoulder arthroscopy

interscalene block (ISB); superior trunk block (STB)

Ultrasound DEVICE

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

interscalene block (ISB); superior trunk block (STB)

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Hospital for Special Surgery, New York: lead

Study Sites (1)

Hospital for Special Surgery

New York, New York, 10021, United States

Location

MeSH Terms

Conditions

Joint Diseases; Pain; Acute Pain; Chronic Pain

Interventions

Bupivacaine; Ultrasonography

Condition Hierarchy (Ancestors)

Musculoskeletal Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis

Results Point of Contact

• Title: Dr. David Kim
• Organization: Department of Anesthesiology, Critical Care & Pain Management

kimd@hss.edu

212-606-1206

Study Officials

• David H Kim, MD

  Hospital for Special Surgery, New York

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 29, 2017
• First Posted: September 5, 2017
• Study Start: September 28, 2017
• Primary Completion: December 30, 2018
• Study Completion: July 9, 2019
• Last Updated: May 11, 2022
• Results First Posted: April 29, 2020

Record last verified: 2022-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)