Ropivacaine Though Laterosternal Catheters After Cardiac Surgery

Sponsor

University Hospital, Clermont-Ferrand (Other)

Overall Status

Completed

CT.gov ID

NCT01196767

Collaborator

(none)

Enrollment

Location

Arms

Duration (Months)

9.9

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Cardiac Surgery	Drug: Ropivacaine (in one arm); catheterization (in both).	Phase 4

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

40 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Investigator)

Official Title:

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

Study Start Date :

Jul 1, 2010

Actual Primary Completion Date :

Nov 1, 2010

Actual Study Completion Date :

Nov 1, 2010

Arms and Interventions

Arm	Intervention/Treatment
Experimental: ropivacaine	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.
Other: normal saline	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.

Arm

Intervention/Treatment

Experimental: ropivacaine

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.

Other: normal saline

Drug: Ropivacaine (in one arm); catheterization (in both).

Outcome Measures

Primary Outcome Measures

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 Outcome Measures

Morphine consumption on PCA device [every 4 hours during 48 hours]
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]
Time to first flatus [daily 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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 90 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.