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

NCT02677532 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 51

Last updated 2016-02-09

No results posted yet for this study

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

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

Sponsors & Collaborators

  • University of Genova

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-12-31
Primary Completion
2013-11-30
Completion
2014-01-31

Countries

  • Italy

Study Locations

More Related Trials

Entities

Drugs

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 NCT02677532 on ClinicalTrials.gov