Skip to main content
OpenTrials
Completed

NCT Number: NCT03272139

Interscalene Block Versus Superior Trunk Block

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).

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Joint Disease Acute Pain Chronic Pain Joint Diseases Musculoskeletal Diseases Neurologic Manifestations Pain Pain, Acute Pain, Chronic Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Hospital for Special Surgery

New York, 10021, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Bupivacaine

Drug

Anesthetic that will help treat pain and sensation after shoulder arthroscopy

Ultrasound

Device

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

Primary outcomes

  1. Number of Participants With Incidence of Hemidiaphragmatic Paralysis (HDP)

    Time frame: 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.

  2. Numerical Pain Rating System (NRS) Pain Scores

    Time frame: 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 outcomes

  1. Block Duration

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Hospital for Special Surgery, New York

Other

Registry information

Official study title

Interscalene Block Versus Superior Trunk Block: A Randomized Controlled Clinical Trial

Acronym: STB

Important dates

Study start
2017
Primary completion
2018
Study completion
2019
First posted
Sep 5, 2017
Registry last updated
May 11, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.