drugset / Trial / NCT02851394

Advantage of Tramadol in Local Analgesia Post-Sternotomy

NCT02851394

Phase 4 Completed 160 enrolled Centre Hospitalier Universitaire Dijon
RandomizedParallel-groupDouble-blindTreatment

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.

Timeline

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

Drugs

EvaluationDrugModalityDoseRoute
Subject Tramadol Other / unclassified 2 mg/kg Other
Comparator Levobupivacaine Other / unclassified 1.25 % Other

Indications

No indication recorded.