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Ropivacaine After Sternotomy (NAROSYD)

Primary Purpose

Postoperative Pain

Status
Completed
Phase
Phase 4
Locations
Finland
Study Type
Interventional
Intervention
Ropivacaine
Sponsored by
Kuopio University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Postoperative Pain focused on measuring Requirement of postoperative pain medication

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Kuopio University hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Ropivacaine

Placebo

Arm Description

Ropivacaine 4 ml/h (8 mg/h) continuous infusion for 48 hours

Saline infusion 4 ml/h for 48 hours

Outcomes

Primary Outcome Measures

Postoperative oxycodone consumption
postoperative PCA administered oxycodone

Secondary Outcome Measures

Pain measured with Visual Analog Scale
pain measured with VAS at rest and on movement

Full Information

First Posted
May 18, 2015
Last Updated
April 23, 2018
Sponsor
Kuopio University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT02449486
Brief Title
Ropivacaine After Sternotomy
Acronym
NAROSYD
Official Title
Ropivacaine Infusion to Alleviate Postoperative Pain After Cardiac Surgery
Study Type
Interventional

2. Study Status

Record Verification Date
April 2018
Overall Recruitment Status
Completed
Study Start Date
January 2014 (Actual)
Primary Completion Date
December 2017 (Actual)
Study Completion Date
December 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Kuopio University Hospital

4. Oversight

Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postoperative Pain
Keywords
Requirement of postoperative pain medication

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
90 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Ropivacaine
Arm Type
Active Comparator
Arm Description
Ropivacaine 4 ml/h (8 mg/h) continuous infusion for 48 hours
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Saline infusion 4 ml/h for 48 hours
Intervention Type
Drug
Intervention Name(s)
Ropivacaine
Primary Outcome Measure Information:
Title
Postoperative oxycodone consumption
Description
postoperative PCA administered oxycodone
Time Frame
48 postoperative hours
Secondary Outcome Measure Information:
Title
Pain measured with Visual Analog Scale
Description
pain measured with VAS at rest and on movement
Time Frame
48 postoperative hours

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pasi K Lahtinen, MD, PhD
Organizational Affiliation
Kuopio University Hospital
Official's Role
Study Director
Facility Information:
Facility Name
Kuopio University hospital
City
Kuopio
ZIP/Postal Code
FI70029
Country
Finland

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
Data will be published in a peer reviewed medical publication

Learn more about this trial

Ropivacaine After Sternotomy

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