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Comparison of the Local Anaesthetics Articaine and Bupivacaine in Treatment of Acute Sternum Pain After Heart Surgery

NCT01536717 · Status: SUSPENDED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 36

Last updated 2019-05-07

No results posted yet for this study

Summary

The purpose of this study is to examine the wound infusion of articaine for treatment of acute post-sternotomy pain in a placebo-controlled manner using a prospective and randomized design and an active control (bupivacaine)

Conditions

  • Diseases of Mitral Valve
  • Aortic Valve Disorder
  • Atrial Septal Defects
  • Intracardiac Myxoma

Interventions

DRUG

Articaine hydrochloride 2% solution

* 4 ml/h periosteal wound infusion * duration of 72 h

DRUG

Sodium Chloride

Placebo Sodium chloride 0,9%

Sponsors & Collaborators

  • Helsinki University Central Hospital

    lead OTHER

Principal Investigators

  • Reino Pöyhiä, MD, PhD · Department of Anesthesiology and Intensive care, Division of Surgery, Meilahti Hospital, Helsinki University Central Hospital

  • Mihkel Meinberg, MD · Department of Anesthesiology and Intensive care medicine, Division of Surgery, Meilahti Hospital, Helsinki University Central Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2012-03-31
Primary Completion
2022-12-31
Completion
2022-12-31

Countries

  • Finland

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 NCT01536717 on ClinicalTrials.gov