NCT00802048

Brief Summary

Cardiac surgery often induces acute postoperative pain and moreover chronic dysesthesia frequently occur long-term after sternotomy. The high doses of intraoperative opioïds are well known to enhance postoperative hyperalgesia (HA) and a perioperative local anesthetic agent infusion is one of the therapeutic strategies used to limit this phenomena. The aim of this study was to evaluate the effectiveness of a continuous Ropivacaïne sternal infusion compared with a saline serum infusion to limit postoperative HA, pain and morphine consumption (M) after sternotomy in cardiac surgery. This strategy could lead to lower postoperative morphine consumption and opioïd induced hyperalgesia.

Trial Health

57
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Trial Health Score

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

Enrollment
21

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Feb 2009

Geographic Reach
1 country

1 active site

Status
terminated

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

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 3, 2008

Completed
1 day until next milestone

First Posted

Study publicly available on registry

December 4, 2008

Completed
2 months until next milestone

Study Start

First participant enrolled

February 1, 2009

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2010

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2010

Completed
Last Updated

December 13, 2011

Status Verified

December 1, 2011

Enrollment Period

11 months

First QC Date

December 3, 2008

Last Update Submit

December 12, 2011

Conditions

HyperalgesiaPain

Keywords

SternotomyPostoperative hyperalgesiaIntralesional anesthetic infusionRopivacaïneChronicPostoperative painCardiac surgerySternumCardiac surgical procedures

Outcome Measures

Primary Outcomes (1)

  • hyperalgesia area size around the cicatrix

    24h after surgery

Secondary Outcomes (4)

  • Peroperative monitoring datas

    Peroperative

  • Dynamic hyperalgesia

    Day 2, 3 and 6

  • Static hyperalgesia

    Day 1, 2, 3 and 6

  • Ropivacaine plasmatic concentration

    24h and 48h

Study Arms (2)

1

EXPERIMENTAL

48h postoperative infusion of ropivacaine

Drug: Local anesthetic (Ropivacaine)

2

PLACEBO COMPARATOR

48h postoperative infusion of NaCl.

Drug: Saline

Interventions

Local anesthetic (Ropivacaine)DRUG

Local anesthetic infusion

1
SalineDRUG

Saline serum infusion

2

Eligibility Criteria

Age50 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients aged from 50 to 75 years old
  • ASA score : 1-3
  • Cardiac surgery with median sternotomy for:
  • single valve replacement, Bentall, Bahnson, Tyrone David procedure
  • single or multiple Cardiac Artery Bypass Grafting (CABG)
  • combined surgery (valve replacement + CABG)
  • without predicted risk of postoperative complication
  • Informed consent obtained from the patient
  • Patient beneficiating of social insurance

You may not qualify if:

  • patient refusal to participate in the study
  • Drug or alcohol abuse history
  • Analgesic or opioid consumption within the 12 hours preceding the surgery
  • Chronic use of analgesic drugs or history of chronic pain
  • Disability to understand morphine PCA use
  • Allergy to ropivacaine or other local anaesthesia
  • Patient treated by fluvoxamine or enoxamine
  • Patient suffering for liver insufficiency (child score \>A)
  • Patient with major preoperative hypovolemia

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Département d'Anesthésie-Réanimation II - Hôpital cardiologique - Groupe Hospitalier Sud, CHU de Bordeaux - 4, Av de Magellan

Pessac, 33604, France

Location

MeSH Terms

Conditions

HyperalgesiaPainBronchiolitis Obliterans SyndromePain, Postoperative

Interventions

Anesthetics, LocalRopivacaineSodium Chloride

Condition Hierarchy (Ancestors)

Somatosensory DisordersSensation DisordersNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and SymptomsOrganizing PneumoniaBronchiolitis ObliteransBronchiolitisBronchitisBronchial DiseasesRespiratory Tract DiseasesLung Diseases, ObstructiveLung DiseasesGraft vs Host DiseaseImmune System DiseasesPostoperative ComplicationsPathologic Processes

Intervention Hierarchy (Ancestors)

AnestheticsCentral Nervous System DepressantsPhysiological Effects of DrugsPharmacologic ActionsChemical Actions and UsesSensory System AgentsPeripheral Nervous System AgentsCentral Nervous System AgentsTherapeutic UsesAnilidesAmidesOrganic ChemicalsAniline CompoundsAminesChloridesHydrochloric AcidChlorine CompoundsInorganic ChemicalsSodium Compounds

Study Officials

  • Olivier POUQUET, Dr

    University Hospital, Bordeaux

    PRINCIPAL INVESTIGATOR

  • Antoine BENARD, Dr

    University Hospital, Bordeaux

    STUDY CHAIR

  • Mathieu LAFARGUE, MD

    University Hospital, Bordeaux

    PRINCIPAL INVESTIGATOR

  • Alexandre OUATTARA, MD

    University Hospital, Bordeaux

    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

December 3, 2008

First Posted

December 4, 2008

Study Start

February 1, 2009

Primary Completion

January 1, 2010

Study Completion

August 1, 2010

Last Updated

December 13, 2011

Record last verified: 2011-12

Locations

FR(1)