CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 36 enrolled
Drug / intervention
Levobupivacaine +1 moredrug
Likely dose
Levobupivacaine 20 mlfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02893228
NCT02893228Phase 4Completed

Does Saline Injection Around Phrenic Nerve Reduce Incidence of Diaphragmatic Paresis Following Interscalene Block?

The Adelaide and Meath Hospital, incorporating The National Children's Hospital·interventional·Posted Sep 8, 2016·Updated Jul 20, 2021

In Brief

A Phase 4 clinical trial evaluating Saline and Levobupivacaine for Phrenic Nerve Palsy. Completed, enrolled 36 participants across 1 site.

Detailed Summary

Hemi-diaphragmatic palsy is a common undesirable effect of interscalene block, with an incidence of up to 100%. Mechanism of palsy is thought to be related to spread of local anaesthetic anterior to the anterior scalene muscle. We hypothesize that by injecting saline in this anatomical location prior to performing an interscalene block the incidence of phrenic palsy will be reduced.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesIreland
Collaborators--

Timeline

Phase 4CompletedFinished
2017201820192020202120222023202420252026
First PostedSep 8, 2016
Enrollment StartOct 1, 2016
Primary CompletionSep 1, 2019
Study CompletionNov 1, 2019
TodayJul 2, 2026
Enrollment to primary: 2.9 yearsPosted 9.8 years ago

Interventions

Salineprocedure

At the location chosen for interscalene block the needle tip will be positioned anterior to the anterior scalene muscle. At this point 10ml of 0.9% saline will be injected.

Levobupivacainedrug

the needle tip will then be positioned between C5 and C6 nerve roots. At this location, 20 ml of 0.25% levobupivacaine will be injected in 5 ml increments with intermittent aspiration. The needle tip will not be repositioned unless the patient complaints of paraesthesia