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

University of Genova

Status and phase: Completed; Phase 4

Conditions: Postoperative Pain

Treatments: Drug: Levobupivacaine epidural bolus; Drug: Paracetamol; Drug: Sufentanil epidural bolus; Device: Wound infusion catheters placement; Drug: Levobupivacaine plus sufentanil epidural infusion; Drug: Levobupivacaine wound infusion; Device: Epidural catheter placement; Drug: Levobupivacaine wound infiltration; Drug: Morphine

Study type: Interventional

Funder types: Other

Identifiers

NCT02677532

APERIVIP

Details and patient eligibility

About

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.

Enrollment: 51 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Scheduled for elective open aortic aneurism repair

Exclusion criteria

• Patient refusal
• Platelet count < 80*10^3/mcL
• International Normalised Ratio > 1.5
• Other contraindications to the placement of epidural catheter, including ongoing anti platelet or anticoagulant treatment not suspended according to national guidelines

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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51 participants in 2 patient groups

Epidural infusion

Active Comparator group

Description:

Thoracic epidural bolus of 10 ml levobupivacaine 0.25% plus sufentanil 0.15 mcg/kg before end of surgery, followed by continuous epidural infusion of 0.12% levobupivacaine plus 0.4 mcg/ml at 5 ml/h infusion rate for 48 hours.

Treatment:

Drug: Levobupivacaine plus sufentanil epidural infusion

Drug: Sufentanil epidural bolus

Device: Epidural catheter placement

Drug: Paracetamol

Drug: Levobupivacaine epidural bolus

Wound infusion plus morphine bolus

Experimental group

Description:

Intravenous slow bolus of 10 mg morphine, wound infiltration with 10 ml levobupivacaine 0.5%, followed by pre-peritoneal continuous wound infusion of levobupivacaine 0.25% at 4 ml/h infusion rate for 48 hours.

Treatment:

Drug: Levobupivacaine wound infiltration

Device: Wound infusion catheters placement

Drug: Paracetamol

Drug: Levobupivacaine wound infusion

Drug: Morphine