Back to resultsInterscalene Block Versus Superior Trunk Block (STB)
Primary Purpose
Joint Disease, Pain, Pain, Acute
Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Bupivacaine
Ultrasound
Sponsored by
About this trial
This is an interventional treatment trial for Joint Disease
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
Sites / Locations
- Hospital for Special Surgery
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
interscalene block (ISB)
superior trunk block (STB)
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
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.
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.
Secondary Outcome Measures
Block Duration
Length of nerve block reported by Phone call on POD 1 and POD 2 by patient phone call
Full Information
NCT ID
NCT03272139
First Posted
August 29, 2017
Last Updated
April 19, 2022
Sponsor
Hospital for Special Surgery, New York
1. Study Identification
Unique Protocol Identification Number
NCT03272139
Brief Title
Interscalene Block Versus Superior Trunk Block
Acronym
STB
Official Title
Interscalene Block Versus Superior Trunk Block: A Randomized Controlled Clinical Trial
Study Type
Interventional
2. Study Status
Record Verification Date
April 2022
Overall Recruitment Status
Completed
Study Start Date
September 28, 2017 (Actual)
Primary Completion Date
December 30, 2018 (Actual)
Study Completion Date
July 9, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hospital for Special Surgery, New York
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Joint Disease, Pain, Pain, Acute, Pain, Chronic
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
126 (Actual)
8. Arms, Groups, and Interventions
Arm Title
interscalene block (ISB)
Arm Type
Experimental
Arm Description
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.
Arm Title
superior trunk block (STB)
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Bupivacaine
Intervention Description
Anesthetic that will help treat pain and sensation after shoulder arthroscopy
Intervention Type
Device
Intervention Name(s)
Ultrasound
Intervention Description
Ultrasound will help guide the anesthesiologist in performing the different nerve blocks
Primary Outcome Measure Information:
Title
Number of Participants With Incidence of Hemidiaphragmatic Paralysis (HDP)
Description
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.
Time Frame
Day of Surgery, diagnosis confirmed from trained anesthesiologist ultrasound readers
Title
Numerical Pain Rating System (NRS) Pain Scores
Description
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.
Time Frame
Average pain scores at rest recorded Day of Surgery every 30 minutes until discharge according to Post Anaesthetic Discharge Scoring System
Secondary Outcome Measure Information:
Title
Block Duration
Description
Length of nerve block reported by Phone call on POD 1 and POD 2 by patient phone call
Time Frame
Time of block wearing off recorded on Post Operative Day 1 and Post Operative Day 2 as reported via patient phone call.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
David H Kim, MD
Organizational Affiliation
Hospital for Special Surgery, New York
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hospital for Special Surgery
City
New York
State/Province
New York
ZIP/Postal Code
10021
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Interscalene Block Versus Superior Trunk Block
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