Postoperative Analgesia After Cardiac Surgery: Effects of a Continuous Infusion of Ropivacaine Through Laterosternal Catheters
Overview
- Phase
- Phase 4
- Intervention
- Ropivacaine (in one arm); catheterization (in both).
- Conditions
- Cardiac Surgery
- Sponsor
- University Hospital, Clermont-Ferrand
- Enrollment
- 40
- Locations
- 1
- Primary Endpoint
- Pain score at mobilization (lying position for measurement of central venous pressure), expressed on a visual analogue scale.
- Status
- Completed
- Last Updated
- 13 years ago
Overview
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Scheduled cardiac surgery.
Exclusion Criteria
- •- surgery in emergency
- •thoracotomy
- •cardiac graft
- •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
Arms & Interventions
ropivacaine
Intervention: Ropivacaine (in one arm); catheterization (in both).
normal saline
Intervention: Ropivacaine (in one arm); catheterization (in both).
Outcomes
Primary Outcomes
Pain score at mobilization (lying position for measurement of central venous pressure), expressed on a visual analogue scale.
Time Frame: every 4 hours during 48 hours
Secondary Outcomes
- Number of participants with adverse events(daily during 48 hours)
- Postoperative blood level of ropivacaine at day + 1 and day + 2(daily during 48 hours)
- Pain score at rest, expressed on a visual analogue scale.(every 4 hours during 48 hours)
- Arterial blood gases(every 4 hours during 48 hours)
- Postoperative blood level of troponin(every 8 hours during 48 hours)
- Time to first flatus(daily during 48 hours)
- Morphine consumption on PCA device(every 4 hours during 48 hours)
- Vital capacity and inspiratory reserve volume, related to the preoperative values(daily during 48 hours)
- Signs of intoxication to ropivacaine(eventual reports)