Cardiac Surgery
Conditions
Keywords
Sternotomy, Pain, Respiratory function, Opiates, Patient-controlled, Scheduled cardiac surgery under general anaesthesia without any locoregional anaesthesia protocol other than this presently studied
Brief summary
This is a prospective double-blinded and randomised study involving patients undergoing cardiac surgery with median sternotomy, the effects on postoperative analgesia of a 48-hr continuous infusion of ropivacaine 2 mg.mL-1, at the rate of 4 mL.hr-1 through two catheters inserted at the lateral edges of the sternum will be studied, versus a control group in which normal saline will be infused in the same conditions.
Detailed description
Diverse methods for infusion of local anaesthetics after cardiac surgery have been proposed, but none of them provided high-level evidence of efficacy. The catheters studied here are designed for a surgical insertion before closure of the sternotomy, with the aim of infusing the drug the closest possible of the terminations of intercostal nerves.
Interventions
DRUGRopivacaine (in one arm); catheterization (in both).
Parallel study with two groups: 1. ropivacaine (2 mg.mL-1), at the rate of 4 mL.hr-1 through two subcutaneous catheters lateral to the sternum, both alimented by an elastomeric pump. 2. same protocol, with normal saline instead of ropivacaine.
Sponsors
University Hospital, Clermont-Ferrand
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 90 Years
Healthy volunteers
No
Inclusion criteria
* Scheduled cardiac surgery.
Exclusion criteria
* \- surgery in emergency * thoracotomy * cardiac graft * redo * pregnancy * patient's refusal * minor or adult under legal protection * psychiatric ongoing disease * addiction to opiates * ongoing opiate treatment * inability to use a PCA device * respiratory insuffiency (Vital capacity or maximal expired volume per sec. \< 50% of the expected value, or mean PAP \> 50 mmHg) * intra-aortic balloon * severe renal insuffiency * history of allergy or intolerance to: morphine, acetaminophen, bupivacaine.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pain score at mobilization (lying position for measurement of central venous pressure), expressed on a visual analogue scale. | every 4 hours during 48 hours |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Pain score at rest, expressed on a visual analogue scale. | every 4 hours during 48 hours | — |
| Vital capacity and inspiratory reserve volume, related to the preoperative values | daily during 48 hours | — |
| Postoperative blood level of troponin | every 8 hours during 48 hours | — |
| Arterial blood gases | every 4 hours during 48 hours | — |
| Morphine consumption on PCA device | every 4 hours during 48 hours | — |
| Number of participants with adverse events | daily during 48 hours | nausea and vomiting, pruritus |
| Postoperative blood level of ropivacaine at day + 1 and day + 2 | daily during 48 hours | — |
| Signs of intoxication to ropivacaine | eventual reports | — |
| Time to first flatus | daily during 48 hours | — |
Countries
France
Outcome results
None listed