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NCT02449486 Clinical Trial

Ropivacaine After Sternotomy

Postoperative Pain Clinical Trial

— NAROSYD  

Official title:
Ropivacaine Infusion to Alleviate Postoperative Pain After Cardiac Surgery

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT02449486
Other study ID # 5070221
Secondary ID
Status Completed
Phase Phase 4
First received May 18, 2015
Last updated April 23, 2018
Start date January 2014
Est. completion date December 2017

Study information
Verified date April 2018
Source Kuopio University Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility
Status Completed
Enrollment 90
Est. completion date December 2017
Est. primary completion date December 2017
Accepts healthy volunteers No
Gender All
Age group 18 Years to 80 Years
Eligibility 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 Design

Related Conditions & MeSH terms

Intervention

Drug:
• Ropivacaine

Locations
Country Name City State
Finland Kuopio University hospital Kuopio

Sponsors (1)
Lead Sponsor Collaborator
Kuopio University Hospital

Country where clinical trial is conducted

Finland, 

Outcome
Type Measure Description Time frame Safety issue
Primary Postoperative oxycodone consumption postoperative PCA administered oxycodone 48 postoperative hours
Secondary Pain measured with Visual Analog Scale pain measured with VAS at rest and on movement 48 postoperative hours
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