CompletedPhase 4

Ropivacaine Though Laterosternal Catheters After Cardiac Surgery

France40 participantsStarted 2010-07

Plain-language 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.

Who can participate

Age range18 Years – 90 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

What they're measuring

Pain score at mobilization (lying position for measurement of central venous pressure), expressed on a visual analogue scale.

Timeframe: every 4 hours during 48 hours

Trial details

NCT IDNCT01196767

SponsorUniversity Hospital, Clermont-Ferrand

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2010-11

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