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Advantage of Tramadol in Local Analgesia Post-Sternotomy

NCT02851394 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 160

Last updated 2026-02-06

No results posted yet for this study

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.

Conditions

  • Heart Surgery Via Sternotomy
  • Post-operative Analgesia

Interventions

DRUG

Levobupivacaine

DRUG

levobupivacaine

DRUG

tramadol

Sponsors & Collaborators

  • Centre Hospitalier Universitaire Dijon

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-10-31
Primary Completion
2016-05-31
Completion
2016-10-31

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02851394 on ClinicalTrials.gov