Advantage of Tramadol in Local Analgesia Post-Sternotomy

Post-operative Analgesia Clinical Trial

— ATLAS  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02851394
• Other study ID #: Bethenod Ellouze 2014
• Status: Completed
• Phase: Phase 4
• First received: July 28, 2016
• Last updated: October 9, 2017
• Start date: October 2015
• Est. completion date: October 2016

Study information

• Verified date: July 2016
• Source: Centre Hospitalier Universitaire Dijon
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 160
• Est. completion date: October 2016
• Est. primary completion date: May 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Heart Surgery Via Sternotomy
• Post-operative Analgesia

Intervention

Drug:
• Levobupivacaine

• levobupivacaine

• tramadol

Locations

Country	Name	City	State
France	CHU Dijon Bourgogne	Dijon

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire Dijon

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Consumption of morphine, expressed in milligrams, in the post-operative period		48 hour after extubation