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

NCT02893228 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 36

Last updated 2021-07-20

No results posted yet for this study

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.

Conditions

  • Phrenic Nerve Palsy

Interventions

PROCEDURE

Saline

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.

DRUG

Levobupivacaine

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

Sponsors & Collaborators

  • The Adelaide and Meath Hospital, incorporating The National Children's Hospital

    lead OTHER

Principal Investigators

  • Karthikeyan Srinivasan, MD., FCARCSI · Adelaide and Meathe Hospital, Incorporating National Children's Hospital

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-10-31
Primary Completion
2019-09-30
Completion
2019-11-30

Countries

  • Ireland

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02893228 on ClinicalTrials.gov