NCT02677532

Epidural Versus Wound Infusion Plus Morphine Bolus in Open Abdominal Aortic Aneurysm Repair

Analgesia Postoperatoria Mediante Catetere Perdurare e Analgesia Postoperatoria Mediante Infusione Continua Periferia Nell'Intervento Chirurgico Per Riparazione Chirurgica di Aneurismi Dell'Aorta Addominale: Tecniche a Confronto

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 51 (actual)
• Sponsor: University of Genova · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The aim of the study is to determine wether continuous wound infusion with local anaesthetic plus a single dose intravenous morphine is non-inferior to postoperative analgesia provided with continuous thoracic epidural infusion of local anaesthetic plus opiate, in patients undergoing open abdominal aortic aneurism repair.

Conditions

• Postoperative Pain

Interventions

Type	Name	Description
DRUG	Paracetamol	1 g every 8 hours
DRUG	Levobupivacaine wound infiltration	Wound infiltration with 10 ml levobupivacaine 0.5%
DRUG	Levobupivacaine epidural bolus	Epidural bolus of 10 ml 0.25% levobupivacaine
DRUG	Sufentanil epidural bolus	Epidural bolus of 0.15 mcg/kg sufentanil
DRUG	Morphine	Intravenous slow bolus of 10 mg morphine
DEVICE	Epidural catheter placement	Thoracic epidural catheter placement in the T7-T8 or T8-T9 intervertebral space
DEVICE	Wound infusion catheters placement	Pre-peritoneal placement of two catheters for wound infusion
DRUG	Levobupivacaine plus sufentanil epidural infusion	Epidural infusion of levobupivacaine 0.12% plus sufentanil 0.4 mcg/ml at 4 ml/h for 48 h
DRUG	Levobupivacaine wound infusion	Wound infusion with levobupivacaine 0.25% at 4 ml/h for 48 h

Timeline

• Start date: 2011-12-01
• Primary completion: 2013-11-01
• Completion: 2014-01-01
• First posted: 2016-02-09
• Last updated: 2016-02-09

Locations

1 site across 1 country: Italy