Ropivacaine After Sternotomy (NAROSYD)

Kuopio University Hospital

Status and phase: Completed; Phase 4

Conditions: Postoperative Pain

Treatments: Drug: Ropivacaine

Study type: Interventional

Funder types: Other

Identifiers

NCT02449486

5070221

Details and patient eligibility

About

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

Full 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.

Enrollment: 90 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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90 participants in 2 patient groups, including a placebo group

Ropivacaine

Active Comparator group

Description:

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

Treatment:

Drug: Ropivacaine

Placebo

Placebo Comparator group

Description:

Saline infusion 4 ml/h for 48 hours

Treatment:

Drug: Ropivacaine