Ropivacaine Though Laterosternal Catheters After Cardiac Surgery

Cardiac Surgery Clinical Trial

Official title:

Postoperative Analgesia After Cardiac Surgery: Effects of a Continuous Infusion of Ropivacaine Through Laterosternal Catheters

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01196767
• Other study ID #: CHU-0080
• Status: Completed
• Phase: Phase 4
• First received: July 26, 2010
• Last updated: April 2, 2013
• Start date: July 2010
• Est. completion date: November 2010

Study information

• Verified date: April 2013
• Source: University Hospital, Clermont-Ferrand
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: November 2010
• Est. primary completion date: November 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 90 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator)

Related Conditions & MeSH terms

• Cardiac Surgery

Intervention

Drug:
• Ropivacaine (in one arm); catheterization (in both).
Parallel study with two groups: 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. same protocol, with normal saline instead of ropivacaine.

Locations

Country	Name	City	State
France	CHU Clermont-Ferrand	Clermont-Ferrand

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Clermont-Ferrand

Country where clinical trial is conducted

France, 

References & Publications (1)

Eljezi V, Dualé 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.0b013 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pain score at mobilization (lying position for measurement of central venous pressure), expressed on a visual analogue scale.		every 4 hours during 48 hours	Yes
Secondary	Morphine consumption on PCA device		every 4 hours during 48 hours	Yes
Secondary	Pain score at rest, expressed on a visual analogue scale.		every 4 hours during 48 hours	Yes
Secondary	Vital capacity and inspiratory reserve volume, related to the preoperative values		daily during 48 hours	Yes
Secondary	Postoperative blood level of troponin		every 8 hours during 48 hours	Yes
Secondary	Arterial blood gases		every 4 hours during 48 hours	Yes
Secondary	Time to first flatus		daily during 48 hours	Yes
Secondary	Number of participants with adverse events	nausea and vomiting, pruritus	daily during 48 hours	Yes
Secondary	Postoperative blood level of ropivacaine at day + 1 and day + 2		daily during 48 hours	Yes
Secondary	Signs of intoxication to ropivacaine		eventual reports	Yes

External Links

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