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NCT03272139: STB

Interscalene Block Versus Superior Trunk Block

Completed Phase 4 Results posted Last updated 11 May 2022
What this trial tests

Phase 4 trial testing Bupivacaine in Joint Disease in 126 participants. Completed in 9 July 2019.

Timeline
28 September 2017
Primary endpoint
30 December 2018
9 July 2019

Quick facts

Lead sponsorHospital for Special Surgery, New York
PhasePhase 4
StatusCompleted
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingtriple
Primary purposetreatment
Enrollment126
Start date28 September 2017
Primary completion30 December 2018
Estimated completion9 July 2019
Sites1 location across United States

Drugs / interventions tested

Conditions studied

Sponsor

Hospital for Special Surgery, New York

Who can join

Adults 18 to 80, any sex, with Joint Disease or Pain. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Number of Participants With Incidence of Hemidiaphragmatic Paralysis (HDP) Primary · 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.

HDP
GroupValue95% CI
Interscalene Block (ISB)45
Superior Trunk Block (STB)3
No HDP
GroupValue95% CI
Interscalene Block (ISB)18
Superior Trunk Block (STB)59
Numerical Pain Rating System (NRS) Pain Scores Primary · 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.

GroupValue95% CI
Interscalene Block (ISB)00 – 2
Superior Trunk Block (STB)00 – 3
Block Duration Secondary · 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

GroupValue95% CI
Interscalene Block (ISB)23.1819.95 – 25.53
Superior Trunk Block (STB)23.1519.12 – 30.07

Sponsor's own description

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).

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.

Verify or expand the search:

Other trials of Bupivacaine

Trials testing the same drug.

Other recruiting trials for Joint Disease

Currently open trials in the same condition.

Other Hospital for Special Surgery, New York trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03272139.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing