Advantage of Tramadol in Local Analgesia Post-Sternotomy (ATLAS)

October 9, 2017 updated by: Centre Hospitalier Universitaire Dijon

Evaluation Of The Efficacy Of A Bolus Infiltration Of The Anaesthetic Tramadol Associated With Continuous Local Anaesthesia Administered Via A Wound Catheter Following Heart Surgery Via Sternotomy At Dijon Chu Single-Centre, Double-Blind, Randomized, Controlled Clinical Trial

Sternotomy, the reference approach for heart surgery, may induce profound and intense post-operative pain. One method of analgesia used is patient-controlled intravenous morphine.

The analgesic efficacy of continuous wound infiltration at the sternum following heart surgery has been demonstrated.

The analgesic catheter placed near the sternotomy wound reduces the consumption of morphine.

The aim of this study is to determine whether a bolus of tramadol associated with the continuous administration of levobupivacaine via the wound catheter could potentiate the local anaesthetic effects, thus leading to a decreased consumption of postoperative intravenous morphine, and a decrease in morphine-related side effects.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

160

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Dijon, France, 21079
        • CHU Dijon Bourgogne

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • ADULT
  • OLDER_ADULT
  • CHILD

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Persons who have provided written consent
  • Patients over 18 years old
  • Patients undergoing heart surgery via sternotomy: aortic valve surgery, mitral valve surgery, tricuspid valve surgery, atrial myxoma, coronary artery bypass graft, aorta surgery
  • Patients undergoing emergency or scheduled surgery

Exclusion Criteria:

  • Adults under guardianship
  • Persons without national health insurance cover
  • Pregnant or breast-feeding women
  • Patients already included in the study once
  • Patients with aortic dissection
  • Patients with mediastinitis or sternal nonunion
  • Patients undergoing heart surgery for the second or more time
  • Patients with local infection or generalized bacteraemia-type infection
  • Patients with hypersensitivity to local anaesthetics or to tramadol or to opiates or to one of the excipients present in the products used
  • Patients with hypersensitivity to paracetamol or to paracetamol hydrochloride (prodrug of paracetamol)
  • Patients on antidepressants, gabapentin, pregabalin, neuroleptics
  • Patients with a history of convulsions or epilepsy
  • Patients with preoperative cognitive dysfunction
  • Patients with intracranial hypertension
  • Chronic use of morphines or high-dose steroid or non-steroid anti-inflammatory agents
  • Patients with acute or chronic kidney failure (creatininemia > 170 µmol/L)
  • Patients with liver failure or porphyria
  • Patients under 17 years old
  • Patients with severe respiratory failure
  • Patients treated with a non-selective MAOI (iproniazid), a selective MAOI A (moclobemid, toloxatone), selective MAO-B inhibitor (Selegiline) or linezolid (Zyvoxid®)
  • Patients with acute intoxication or an overdose of products that depress the central nervous system (alcohol, hypnotics, other analgesics…)
  • Patients with severe hypotension

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: Levobupivacaine group
Drug: Levobupivacaine
EXPERIMENTAL: Levobupivacaine + tramadol group
Drug: tramadol
Drug: levobupivacaine

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Consumption of morphine, expressed in milligrams, in the post-operative period
Time Frame: 48 hour after extubation
48 hour after extubation

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centre Hospitalier Universitaire Dijon

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2015

Primary Completion (ACTUAL)

May 1, 2016

Study Completion (ACTUAL)

October 1, 2016

Study Registration Dates

First Submitted

July 28, 2016

First Submitted That Met QC Criteria

July 29, 2016

First Posted (ESTIMATE)

August 1, 2016

Study Record Updates

Last Update Posted (ACTUAL)

October 10, 2017

Last Update Submitted That Met QC Criteria

October 9, 2017

Last Verified

July 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Bethenod Ellouze 2014

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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