NCT02851394

Advantage of Tramadol in Local Analgesia Post-Sternotomy

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

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 160 (actual)
• Sponsor: Centre Hospitalier Universitaire Dijon · Academic / Other
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

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

Type	Name	Description
DRUG	Levobupivacaine
DRUG	levobupivacaine
DRUG	tramadol

Timeline

• Start date: 2015-10-01
• Primary completion: 2016-05-01
• Completion: 2016-10-01
• First posted: 2016-08-01
• Last updated: 2026-02-06

Locations

1 site across 1 country: France