Ropivacaine After Sternotomy (NAROSYD)

April 23, 2018 updated by: Kuopio University Hospital

Ropivacaine Infusion to Alleviate Postoperative Pain After Cardiac Surgery

Continuous ropivacaine infusion to sternotomy wound after coronary artery bypass grafting (CABG) or heart valve surgery to diminish postoperative pain.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

A multiporous catheter will be introduced into sternotomy wound to CABG or heart valve surgery patients and continuous ropivacaine infusion 4 ml/h will be started immediately after surgery. Ropivacaine infusion will be administered during 48 postoperative hours. All patients receive patient controlled analgesia (PCA) oxycodone after extubation in the PACU. All patients receive a standardized anesthesia during surgery.

Study Type

Interventional

Enrollment (Actual)

90

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Finland
      • Kuopio, Finland, FI70029
        • Kuopio University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Elective CABG or heart valve surgery patients

Exclusion Criteria:

  • Psychic disorders
  • Sleep apnea syndrome
  • Diabetes mellitus (insulin dependent)
  • Obesity, body mass index (BMI) ≥ 35
  • Cardiac insufficiency, ejection fraction (EF) ≤ 30

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Ropivacaine
Ropivacaine 4 ml/h (8 mg/h) continuous infusion for 48 hours
Drug: Ropivacaine
Placebo Comparator: Placebo
Saline infusion 4 ml/h for 48 hours
Drug: Ropivacaine

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Postoperative oxycodone consumption
Time Frame: 48 postoperative hours
postoperative PCA administered oxycodone
48 postoperative hours

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pain measured with Visual Analog Scale
Time Frame: 48 postoperative hours
pain measured with VAS at rest and on movement
48 postoperative hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Kuopio University Hospital

Investigators

  • Study Director: Pasi K Lahtinen, MD, PhD, Kuopio University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2014

Primary Completion (Actual)

December 1, 2017

Study Completion (Actual)

December 1, 2017

Study Registration Dates

First Submitted

May 18, 2015

First Submitted That Met QC Criteria

May 19, 2015

First Posted (Estimate)

May 20, 2015

Study Record Updates

Last Update Posted (Actual)

April 24, 2018

Last Update Submitted That Met QC Criteria

April 23, 2018

Last Verified

April 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 5070221

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Data will be published in a peer reviewed medical publication

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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