NCT01648777

Brief Summary

Pneumonia occurs frequently in patients undergoing cardiac surgery and allows to increase their mortality. While chest physical therapy plays a crucial role to prevent postoperative pneumoniae, painful mobilization of the sternum after sternotomy limits chest physical therapy. The continuous local anesthetic infusion by multiperforated catheter decreases sternum pain. Because of this optimal pain management, early chest physical therapy could be more efficient and could contribute to decrease the rate of pneumonia. The aim of this study is to test if management of sternotomy pain using continuous local anesthetic infusion by multiperforated catheter may contribute to decrease the rate of perioperative pneumonia.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
1,502

participants targeted

Target at P75+ for phase_3

Timeline
Completed

Started Mar 2012

Typical duration for phase_3

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

March 1, 2012

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

July 20, 2012

Completed
4 days until next milestone

First Posted

Study publicly available on registry

July 24, 2012

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2015

Completed
Last Updated

April 24, 2015

Status Verified

November 1, 2013

Enrollment Period

2.8 years

First QC Date

July 20, 2012

Last Update Submit

April 23, 2015

Conditions

PneumoniaCardiac SurgeryMultiperforated CatheterAnalgesiaCritical Care Medicine

Keywords

PneumoniaPostoperative infectionCardiac surgeryMultiperforated catheterAnalgesia

Outcome Measures

Primary Outcomes (1)

  • Rate of post-operative pneumonia in hospital

    30 days

Secondary Outcomes (10)

  • all-cause mortality

    30 days

  • mechanical ventilation free days

    30 days

  • ICU free days

    30 days

  • Hospital stay

    30 days

  • Rate of ICU readmission

    30 days

  • +5 more secondary outcomes

Study Arms (2)

L bupivacaine

EXPERIMENTAL

Drug (L bupivacaine) and device (catheter) 750 patients undergoing cardiac surgery with sternotomy are treated with L-bupivacain in the multiperforated catheter of analgesia

Device: L bupivacaine

placebo

PLACEBO COMPARATOR

Isotonic Nacl 9°/00 solution 750 patients undergoing cardiac surgery with sternotomy are treated with isotonic NaCl solution (placebo) in the multiperforated catheter of analgesia

Drug: placebo

Interventions

L bupivacaineDEVICE

L-bupivacain solution CHIROCAINE® 5mg/ml, flakon de 20 ml): for the intravenous bolus of 10 ml o (CHIROCAINE®1.25mg/ml, 200 mL/unit, 400 ml in the accufusor infused at 8ml/h during 48h00: for infusion during 48h00

Also known as: catheter with L bupivacaine
L bupivacaine
placeboDRUG

* Isotonic NaCl solution (9°/00) solution: for the intravenous bolus of 10 ml * Isotonic NaCl solution (9°/00) solution, 400 ml in the accufusor infused at 8ml/h during 48h00: for infusion during 48h00

Also known as: Isotonic NaCl solution
placebo

Eligibility Criteria

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

You may qualify if:

  • all patient more than 18 years old
  • planned cardiac surgery with sternotomy and bypass
  • Informed consent written

You may not qualify if:

  • Refusal of patient to be included in the study
  • Age less than 18 years old
  • Pregnancy
  • Emergency
  • Prolonged sedation and ventilation more than 48h00 expected in teh postoperative period
  • Moribund patient
  • Palliative medicine
  • Patient in the care of a guardian
  • Preoperative pneumonia
  • Patient randomized in an other randomized study
  • Contraindication to L-bupivacain, morphine sulfate, paracetamol or tramadol
  • Lack of national health care insurance

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Pitié salpetrière Hospital

Paris, 75013, France

Location

Related Publications (1)

  • Amour J, Cholley B, Ouattara A, Longrois D, Leprince P, Fellahi JL, Riou B, Hariri S, Latremouille C, Remy A, Provenchere S, Carillion A, Achouh P, Labrousse L, Tran Dinh A, Ait Hamou N, Charfeddine A, Lafourcade A, Hajage D, Bougle A; STERNOCAT investigators. The effect of local anesthetic continuous wound infusion for the prevention of postoperative pneumonia after on-pump cardiac surgery with sternotomy: the STERNOCAT randomized clinical trial. Intensive Care Med. 2019 Jan;45(1):33-43. doi: 10.1007/s00134-018-5497-x. Epub 2019 Jan 7.

    PMID: 30617461DERIVED

MeSH Terms

Conditions

PneumoniaAgnosia

Interventions

Catheters

Condition Hierarchy (Ancestors)

Respiratory Tract InfectionsInfectionsLung DiseasesRespiratory Tract DiseasesPerceptual DisordersNeurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Equipment and Supplies

Study Officials

  • Julien Amour, MD, PhD

    APHP

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 20, 2012

First Posted

July 24, 2012

Study Start

March 1, 2012

Primary Completion

January 1, 2015

Study Completion

January 1, 2015

Last Updated

April 24, 2015

Record last verified: 2013-11

Locations

FR(1)