Ropivacaine Though Laterosternal Catheters After Cardiac Surgery

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

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.

Study Overview

• Status: Completed
• Conditions: Cardiac Surgery
• Intervention / Treatment: Drug: Ropivacaine (in one arm); catheterization (in both).

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 Type: Interventional
• Enrollment (Actual): 40
• Phase: Phase 4

Contacts and Locations

Study Locations

• France
  • Clermont-Ferrand, France, 63003
    • Chu Clermont-Ferrand

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 86 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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

Outcome Measure	Measure Description	Time Frame
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	nausea and vomiting, pruritus	daily during 48 hours
Postoperative blood level of ropivacaine at day + 1 and day + 2		daily during 48 hours
Signs of intoxication to ropivacaine		eventual reports

Collaborators and Investigators

• Sponsor: University Hospital, Clermont-Ferrand
• Investigators: Principal Investigator: Vedat Eldjezi, MB, University Hospital, Clermont-Ferrand

Publications and helpful links

General Publications

• 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.

Helpful Links

• Related Info

Study record dates

Study Major Dates

• Study Start: July 1, 2010
• Primary Completion (Actual): November 1, 2010
• Study Completion (Actual): November 1, 2010

Study Registration Dates

• First Submitted: July 26, 2010
• First Submitted That Met QC Criteria: September 7, 2010
• First Posted (Estimate): September 8, 2010

Study Record Updates

• Last Update Posted (Estimate): April 4, 2013
• Last Update Submitted That Met QC Criteria: April 2, 2013
• Last Verified: April 1, 2013

More Information

Terms related to this study

• Keywords: Pain; Opiates; Sternotomy; Respiratory function; Patient-controlled; Scheduled cardiac surgery under general anaesthesia without any locoregional anaesthesia protocol other than this presently studied
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Sensory System Agents; Anesthetics; Anesthetics, Local; Ropivacaine
• Other Study ID Numbers: CHU-0080