Epidural Versus Wound Infusion Plus Morphine Bolus in Open Abdominal Aortic Aneurysm Repair
NCT ID: NCT02677532
Last Updated: 2016-02-09
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE4
51 participants
INTERVENTIONAL
2011-12-31
2014-01-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Epidural infusion
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.
Paracetamol
1 g every 8 hours
Levobupivacaine epidural bolus
Epidural bolus of 10 ml 0.25% levobupivacaine
Sufentanil epidural bolus
Epidural bolus of 0.15 mcg/kg sufentanil
Epidural catheter placement
Thoracic epidural catheter placement in the T7-T8 or T8-T9 intervertebral space
Levobupivacaine plus sufentanil epidural infusion
Epidural infusion of levobupivacaine 0.12% plus sufentanil 0.4 mcg/ml at 4 ml/h for 48 h
Wound infusion plus morphine bolus
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.
Paracetamol
1 g every 8 hours
Levobupivacaine wound infiltration
Wound infiltration with 10 ml levobupivacaine 0.5%
Morphine
Intravenous slow bolus of 10 mg morphine
Wound infusion catheters placement
Pre-peritoneal placement of two catheters for wound infusion
Levobupivacaine wound infusion
Wound infusion with levobupivacaine 0.25% at 4 ml/h for 48 h
Interventions
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Paracetamol
1 g every 8 hours
Levobupivacaine wound infiltration
Wound infiltration with 10 ml levobupivacaine 0.5%
Levobupivacaine epidural bolus
Epidural bolus of 10 ml 0.25% levobupivacaine
Sufentanil epidural bolus
Epidural bolus of 0.15 mcg/kg sufentanil
Morphine
Intravenous slow bolus of 10 mg morphine
Epidural catheter placement
Thoracic epidural catheter placement in the T7-T8 or T8-T9 intervertebral space
Wound infusion catheters placement
Pre-peritoneal placement of two catheters for wound infusion
Levobupivacaine plus sufentanil epidural infusion
Epidural infusion of levobupivacaine 0.12% plus sufentanil 0.4 mcg/ml at 4 ml/h for 48 h
Levobupivacaine wound infusion
Wound infusion with levobupivacaine 0.25% at 4 ml/h for 48 h
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* 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
18 Years
ALL
No
Sponsors
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University of Genova
OTHER
Responsible Party
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Paolo Pelosi
Professor
Locations
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UO Anestesia e Terapia Intensiva, IRCCS AOU San-Martino IST
Genova, Genova, Italy
Countries
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Other Identifiers
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APERIVIP
Identifier Type: -
Identifier Source: org_study_id
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