Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Interscalene Block Versus Superior Trunk Block (STB)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03272139
Recruitment Status : Completed
First Posted : September 5, 2017
Results First Posted : April 29, 2020
Last Update Posted : April 29, 2020
Sponsor:
Information provided by (Responsible Party):
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).

Condition or disease Intervention/treatment Phase
Joint Disease Pain Pain, Acute Pain, Chronic Drug: Bupivacaine Device: Ultrasound Phase 4

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 126 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Interscalene Block Versus Superior Trunk Block: A Randomized Controlled Clinical Trial
Actual Study Start Date : September 28, 2017
Actual Primary Completion Date : December 30, 2018
Actual Study Completion Date : July 9, 2019

Resource links provided by the National Library of Medicine

Drug Information available for: Bupivacaine

Arm Intervention/treatment
Experimental: 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.
Drug: Bupivacaine
Anesthetic that will help treat pain and sensation after shoulder arthroscopy

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

Experimental: 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.
Drug: Bupivacaine
Anesthetic that will help treat pain and sensation after shoulder arthroscopy

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




Primary Outcome Measures :
  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 Outcome Measures :
  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



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03272139


Locations
Layout table for location information
United States, New York
Hospital for Special Surgery
New York, New York, United States, 10021
Sponsors and Collaborators
Hospital for Special Surgery, New York
Investigators
Layout table for investigator information
Principal Investigator: David H Kim, MD Hospital for Special Surgery, New York
  Study Documents (Full-Text)

Documents provided by Hospital for Special Surgery, New York:
Layout table for additonal information
Responsible Party: Hospital for Special Surgery, New York
ClinicalTrials.gov Identifier: NCT03272139    
Other Study ID Numbers: 2017-0979
First Posted: September 5, 2017    Key Record Dates
Results First Posted: April 29, 2020
Last Update Posted: April 29, 2020
Last Verified: April 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Joint Diseases
Acute Pain
Chronic Pain
Musculoskeletal Diseases
Pain
Neurologic Manifestations
Bupivacaine
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents