MedPath

Ropivacaine After Sternotomy

Phase 4
Completed
Conditions
Postoperative Pain
Interventions
Registration Number
NCT02449486
Lead Sponsor
Kuopio University Hospital
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.

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
90
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

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
RopivacaineRopivacaineRopivacaine 4 ml/h (8 mg/h) continuous infusion for 48 hours
PlaceboRopivacaineSaline infusion 4 ml/h for 48 hours
Primary Outcome Measures
NameTimeMethod
Postoperative oxycodone consumption48 postoperative hours

postoperative PCA administered oxycodone

Secondary Outcome Measures
NameTimeMethod
Pain measured with Visual Analog Scale48 postoperative hours

pain measured with VAS at rest and on movement

Trial Locations

Locations (1)

Kuopio University hospital

🇫🇮

Kuopio, Finland

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