NCT01196767

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Jul 2010

Shorter than P25 for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2010

Completed
25 days until next milestone

First Submitted

Initial submission to the registry

July 26, 2010

Completed
1 month until next milestone

First Posted

Study publicly available on registry

September 8, 2010

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2010

Completed
Last Updated

April 4, 2013

Status Verified

April 1, 2013

Enrollment Period

4 months

First QC Date

July 26, 2010

Last Update Submit

April 2, 2013

Conditions

Cardiac Surgery

Keywords

SternotomyPainRespiratory functionOpiatesPatient-controlledScheduled cardiac surgery under general anaesthesia without any locoregional anaesthesia protocol other than this presently studied

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (9)

  • 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

  • +4 more secondary outcomes

Study Arms (2)

ropivacaine

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

normal saline

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

Interventions

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

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 salineropivacaine

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Scheduled cardiac surgery.

You may not qualify if:

  • \- 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHU Clermont-Ferrand

Clermont-Ferrand, 63003, France

Location

Related Publications (1)

  • 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.

    PMID: 22266899RESULT

Related Links

MeSH Terms

Conditions

PainRespiratory Aspiration

Interventions

RopivacaineCatheterization

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsRespiration DisordersRespiratory Tract DiseasesPathologic Processes

Intervention Hierarchy (Ancestors)

AnilidesAmidesOrganic ChemicalsAniline CompoundsAminesTherapeuticsInvestigative Techniques

Study Officials

  • Vedat Eldjezi, MB

    University Hospital, Clermont-Ferrand

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 26, 2010

First Posted

September 8, 2010

Study Start

July 1, 2010

Primary Completion

November 1, 2010

Study Completion

November 1, 2010

Last Updated

April 4, 2013

Record last verified: 2013-04

Locations

FR(1)