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NCT Number: NCT01196767

Ropivacaine Though Laterosternal Catheters After Cardiac Surgery

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.

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Key information

Conditions

Cardiac Surgery Neurologic Manifestations Pain Pathologic Processes Pathological Conditions, Signs and Symptoms Respiration Disorders Respiratory Aspiration Respiratory Tract Diseases Signs and Symptoms

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

CHU Clermont-Ferrand

Clermont-Ferrand, 63003, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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

Drug

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.

Primary outcomes

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

    Time frame: every 4 hours during 48 hours

Secondary outcomes

  1. Morphine consumption on PCA device

    Time frame: every 4 hours during 48 hours

  2. Pain score at rest, expressed on a visual analogue scale.

    Time frame: every 4 hours during 48 hours

  3. Vital capacity and inspiratory reserve volume, related to the preoperative values

    Time frame: daily during 48 hours

  4. Postoperative blood level of troponin

    Time frame: every 8 hours during 48 hours

  5. Arterial blood gases

    Time frame: every 4 hours during 48 hours

  6. Time to first flatus

    Time frame: daily during 48 hours

  7. Number of participants with adverse events

    Time frame: daily during 48 hours

    nausea and vomiting, pruritus

  8. Postoperative blood level of ropivacaine at day + 1 and day + 2

    Time frame: daily during 48 hours

  9. Signs of intoxication to ropivacaine

    Time frame: eventual reports

Sponsors and collaborators

Lead sponsor

University Hospital, Clermont-Ferrand

Other

Registry information

Official study title

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

Important dates

Study start
2010
Primary completion
2010
Study completion
2010
First posted
Sep 8, 2010
Registry last updated
Apr 4, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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