Interscalene Block Versus Superior Trunk Block

Pain Clinical Trial

— STB  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03272139
• Other study ID #: 2017-0979
• Status: Completed
• Phase: Phase 4
• Start date: September 28, 2017
• Est. completion date: July 9, 2019

Study information

• Verified date: April 2022
• Source: Hospital for Special Surgery, New York
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 126
• Est. completion date: July 9, 2019
• Est. primary completion date: December 30, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Acute Pain
• Chronic Pain
• Joint Disease
• Joint Diseases
• Pain
• Pain, Acute
• Pain, Chronic

Intervention

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

Locations

Country	Name	City	State
United States	Hospital for Special Surgery	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
Hospital for Special Surgery, New York

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	Block Duration	Length of nerve block reported by Phone call on POD 1 and POD 2 by patient phone call	Time of block wearing off recorded on Post Operative Day 1 and Post Operative Day 2 as reported via patient phone call.