NCT02851394

Brief 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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
160

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Oct 2015

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

October 1, 2015

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2016

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

July 28, 2016

Completed
4 days until next milestone

First Posted

Study publicly available on registry

August 1, 2016

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2016

Completed
Last Updated

February 6, 2026

Status Verified

February 1, 2026

Enrollment Period

7 months

First QC Date

July 28, 2016

Last Update Submit

February 4, 2026

Conditions

Post-operative AnalgesiaHeart Surgery Via Sternotomy

Outcome Measures

Primary Outcomes (1)

  • Consumption of morphine, expressed in milligrams, in the post-operative period

    48 hour after extubation

Study Arms (2)

Levobupivacaine group

ACTIVE COMPARATOR
Drug: Levobupivacaine

Levobupivacaine + tramadol group

EXPERIMENTAL
Drug: levobupivacaineDrug: tramadol

Interventions

levobupivacaineDRUG
Levobupivacaine group
tramadolDRUG
Levobupivacaine + tramadol group

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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
  • +7 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHU Dijon Bourgogne

Dijon, 21079, France

Location

Related Publications (1)

  • Bethenod F, Ellouze O, Berthoud V, Missaoui A, Cransac A, Aho S, Bouchot O, Girard C, Guinot PG, Bouhemad B. A single dose of tramadol in continuous wound analgesia with levobupivacaine does not reduce post-sternotomy pain: a randomized controlled trial. J Pain Res. 2019 Sep 18;12:2733-2741. doi: 10.2147/JPR.S211042. eCollection 2019.

    PMID: 31571977RESULT

MeSH Terms

Interventions

LevobupivacaineTramadol

Intervention Hierarchy (Ancestors)

BupivacaineAnilidesAmidesOrganic ChemicalsAniline CompoundsAminesCyclohexanolsHexanolsFatty AlcoholsAlcoholsDimethylaminesMethylaminesLipids

Study Design

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

Study Record Dates

First Submitted

July 28, 2016

First Posted

August 1, 2016

Study Start

October 1, 2015

Primary Completion

May 1, 2016

Study Completion

October 1, 2016

Last Updated

February 6, 2026

Record last verified: 2026-02

Locations

FR(1)