Clinical trial NCT01196767: Ropivacaine Though Laterosternal Catheters After Cardiac Surgery
Official title: Postoperative Analgesia After Cardiac Surgery: Effects of a Continuous Infusion of Ropivacaine Through Laterosternal Catheters
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Cardiac Surgery
Keywords: Sternotomy
Pain
Respiratory function
Opiates
Patient-controlled
Scheduled cardiac surgery under general anaesthesia without any locoregional anaesthesia protocol other than this presently studied
Lead sponsor: University Hospital, Clermont-Ferrand
Sponsor class: OTHER
First posted: 2010-09-08
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL

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.

Eligibility criteria: 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.

Primary outcomes:
measure: 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
Secondary outcomes:
measure: Morphine consumption on PCA device
timeFrame: every 4 hours during 48 hours
measure: Pain score at rest, expressed on a visual analogue scale.
timeFrame: every 4 hours during 48 hours
measure: Vital capacity and inspiratory reserve volume, related to the preoperative values
timeFrame: daily during 48 hours
measure: Postoperative blood level of troponin
timeFrame: every 8 hours during 48 hours
measure: Arterial blood gases
timeFrame: every 4 hours during 48 hours
measure: Time to first flatus
timeFrame: daily during 48 hours
measure: Number of participants with adverse events
timeFrame: daily during 48 hours
measure: Postoperative blood level of ropivacaine at day + 1 and day + 2
timeFrame: daily during 48 hours
measure: Signs of intoxication to ropivacaine
timeFrame: eventual reports
Other outcomes:
Locations:
city: Clermont-Ferrand
country: France
facility: CHU Clermont-Ferrand
Study officials:
affiliation: University Hospital, Clermont-Ferrand
name: Vedat Eldjezi, MB
role: PRINCIPAL_INVESTIGATOR
References:
citation: Eljezi V, Duale C, Azarnoush K, Skrzypczak Y, Sautou V, Pereira B, Tsokanis I, Schoeffler P. The analgesic effects of a bilateral sternal infusion of ropivacaine after cardiac surgery. Reg Anesth Pain Med. 2012 Mar-Apr;37(2):166-74. doi: 10.1097/AAP.0b013e318240957f.