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Ropivacaine Though Laterosternal Catheters After Cardiac Surgery

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
University Hospital, Clermont-Ferrand
ClinicalTrials.gov Identifier:
NCT01196767
First received: July 26, 2010
Last updated: April 2, 2013
Last verified: April 2013
History of Changes
  Purpose

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 Intervention Phase
Cardiac Surgery
 Drug: Ropivacaine (in one arm); catheterization (in both).
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Official Title: Postoperative Analgesia After Cardiac Surgery: Effects of a Continuous Infusion of Ropivacaine Through Laterosternal Catheters

Resource links provided by NLM:

MedlinePlus related topics: Heart Surgery
U.S. FDA Resources

Further study details as provided by University Hospital, Clermont-Ferrand:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Morphine consumption on PCA device [ Time Frame: every 4 hours during 48 hours ] [ Designated as safety issue: Yes ]
  • Pain score at rest, expressed on a visual analogue scale. [ Time Frame: every 4 hours during 48 hours ] [ Designated as safety issue: Yes ]
  • Vital capacity and inspiratory reserve volume, related to the preoperative values [ Time Frame: daily during 48 hours ] [ Designated as safety issue: Yes ]
  • Postoperative blood level of troponin [ Time Frame: every 8 hours during 48 hours ] [ Designated as safety issue: Yes ]
  • Arterial blood gases [ Time Frame: every 4 hours during 48 hours ] [ Designated as safety issue: Yes ]
  • Time to first flatus [ Time Frame: daily during 48 hours ] [ Designated as safety issue: Yes ]
  • Number of participants with adverse events [ Time Frame: daily during 48 hours ] [ Designated as safety issue: Yes ]
    nausea and vomiting, pruritus

  • Postoperative blood level of ropivacaine at day + 1 and day + 2 [ Time Frame: daily during 48 hours ] [ Designated as safety issue: Yes ]
  • Signs of intoxication to ropivacaine [ Time Frame: eventual reports ] [ Designated as safety issue: Yes ]

Enrollment: 40
Study Start Date: July 2010
Study Completion Date: November 2010
Primary Completion Date: November 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: ropivacaine Drug: Ropivacaine (in one arm); catheterization (in both).

Parallel study with two groups:

  1. 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.
  2. same protocol, with normal saline instead of ropivacaine.
normal saline Drug: Ropivacaine (in one arm); catheterization (in both).

Parallel study with two groups:

  1. 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.
  2. same protocol, with normal saline instead of ropivacaine.

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

Ages Eligible for Study:   18 Years to 90 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01196767

Locations
France
CHU Clermont-Ferrand
Clermont-Ferrand, France, 63003
Sponsors and Collaborators
University Hospital, Clermont-Ferrand
Investigators
Principal Investigator: Vedat Eldjezi, MB University Hospital, Clermont-Ferrand
  More Information

Additional Information:
Related Info  This link exits the ClinicalTrials.gov site

Publications:

Responsible Party: University Hospital, Clermont-Ferrand
ClinicalTrials.gov Identifier: NCT01196767     History of Changes
Other Study ID Numbers: CHU-0080
Study First Received: July 26, 2010
Last Updated: April 2, 2013
Health Authority: France: Ministry of Health

Keywords provided by University Hospital, Clermont-Ferrand:
Sternotomy
Pain
Respiratory function
 Opiates
Patient-controlled
Scheduled cardiac surgery under general anaesthesia without any locoregional anaesthesia protocol other than this presently studied

Additional relevant MeSH terms:
Ropivacaine
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
 Pharmacologic Actions
Sensory System Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on June 17, 2013