Epidural Versus Wound Infusion Plus Morphine Bolus in Open Abdominal Aortic Aneurysm Repair (APERIVIP)
Primary Purpose
Postoperative Pain
Status
Completed
Phase
Phase 4
Locations
Italy
Study Type
Interventional
Intervention
Paracetamol
Levobupivacaine wound infiltration
Levobupivacaine epidural bolus
Sufentanil epidural bolus
Morphine
Epidural catheter placement
Wound infusion catheters placement
Levobupivacaine plus sufentanil epidural infusion
Levobupivacaine wound infusion
Sponsored by
About this trial
This is an interventional treatment trial for Postoperative Pain
Eligibility Criteria
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
Sites / Locations
- UO Anestesia e Terapia Intensiva, IRCCS AOU San-Martino IST
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Epidural infusion
Wound infusion plus morphine bolus
Arm 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.
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.
Outcomes
Primary Outcome Measures
Average postoperative pain assessed with numeric rating scale (NRS) in the first 48 hours
Secondary Outcome Measures
Need for rescue doses of morphine at each time-point
Need for a bolus of 5 mg intravenous morphine to relief pain
Number of patients requiring oxygen administration at each time-point
Number of patients that have restored bowel function at each time-point
Time to first stool analysis
Number of patients whose urinary catheter was removed at each time-point
Time to catheter removal analysis
Number of patients that have restored ability to walk at each time-point
Non-invasive blood pressure (mmHg) at each time-point
Blood pressure (systolic, diastolic, mean in mmHg)
Length of hospital stay
Heart rate (bpm) at each time-point
Incidence of postoperative nausea and vomiting
Full Information
NCT ID
NCT02677532
First Posted
January 29, 2016
Last Updated
February 8, 2016
Sponsor
University of Genova
1. Study Identification
Unique Protocol Identification Number
NCT02677532
Brief Title
Epidural Versus Wound Infusion Plus Morphine Bolus in Open Abdominal Aortic Aneurysm Repair
Acronym
APERIVIP
Official Title
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
Study Type
Interventional
2. Study Status
Record Verification Date
February 2016
Overall Recruitment Status
Completed
Study Start Date
December 2011 (undefined)
Primary Completion Date
November 2013 (Actual)
Study Completion Date
January 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Genova
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postoperative Pain
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
51 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Epidural infusion
Arm Type
Active Comparator
Arm 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.
Arm Title
Wound infusion plus morphine bolus
Arm Type
Experimental
Arm 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.
Intervention Type
Drug
Intervention Name(s)
Paracetamol
Intervention Description
1 g every 8 hours
Intervention Type
Drug
Intervention Name(s)
Levobupivacaine wound infiltration
Intervention Description
Wound infiltration with 10 ml levobupivacaine 0.5%
Intervention Type
Drug
Intervention Name(s)
Levobupivacaine epidural bolus
Intervention Description
Epidural bolus of 10 ml 0.25% levobupivacaine
Intervention Type
Drug
Intervention Name(s)
Sufentanil epidural bolus
Intervention Description
Epidural bolus of 0.15 mcg/kg sufentanil
Intervention Type
Drug
Intervention Name(s)
Morphine
Intervention Description
Intravenous slow bolus of 10 mg morphine
Intervention Type
Device
Intervention Name(s)
Epidural catheter placement
Intervention Description
Thoracic epidural catheter placement in the T7-T8 or T8-T9 intervertebral space
Intervention Type
Device
Intervention Name(s)
Wound infusion catheters placement
Intervention Description
Pre-peritoneal placement of two catheters for wound infusion
Intervention Type
Drug
Intervention Name(s)
Levobupivacaine plus sufentanil epidural infusion
Intervention Description
Epidural infusion of levobupivacaine 0.12% plus sufentanil 0.4 mcg/ml at 4 ml/h for 48 h
Intervention Type
Drug
Intervention Name(s)
Levobupivacaine wound infusion
Intervention Description
Wound infusion with levobupivacaine 0.25% at 4 ml/h for 48 h
Primary Outcome Measure Information:
Title
Average postoperative pain assessed with numeric rating scale (NRS) in the first 48 hours
Time Frame
Average of the NRS recorded at the different time-points (up to 48 hours after emergence from general anaesthesia)
Secondary Outcome Measure Information:
Title
Need for rescue doses of morphine at each time-point
Description
Need for a bolus of 5 mg intravenous morphine to relief pain
Time Frame
0, 4, 8, 12, 24, 36, 48 hours after emergence from general anaesthesia
Title
Number of patients requiring oxygen administration at each time-point
Time Frame
0, 4, 8, 12, 24, 36, 48 hours after emergence from general anaesthesia
Title
Number of patients that have restored bowel function at each time-point
Description
Time to first stool analysis
Time Frame
0, 4, 8, 12, 24, 36, 48 hours after emergence from general anaesthesia
Title
Number of patients whose urinary catheter was removed at each time-point
Description
Time to catheter removal analysis
Time Frame
0, 4, 8, 12, 24, 36, 48 hours after emergence from general anaesthesia
Title
Number of patients that have restored ability to walk at each time-point
Time Frame
0, 4, 8, 12, 24, 36, 48 hours after emergence from general anaesthesia
Title
Non-invasive blood pressure (mmHg) at each time-point
Description
Blood pressure (systolic, diastolic, mean in mmHg)
Time Frame
0, 4, 8, 12, 24, 36, 48 hours after emergence from general anaesthesia
Title
Length of hospital stay
Time Frame
Follow-up of up to 3 months after surgery
Title
Heart rate (bpm) at each time-point
Time Frame
0, 4, 8, 12, 24, 36, 48 hours after emergence from general anaesthesia
Title
Incidence of postoperative nausea and vomiting
Time Frame
0, 4, 8, 12, 24, 36, 48 hours after emergence from general anaesthesia
Other Pre-specified Outcome Measures:
Title
Incidence of postoperative cardiovascular adverse events
Time Frame
Intra-hospital follow-up of up to 3 months after surgery
Title
Incidence of postoperative pulmonary complications
Time Frame
Intra-hospital follow-up of up to 3 months after surgery
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
UO Anestesia e Terapia Intensiva, IRCCS AOU San-Martino IST
City
Genova
ZIP/Postal Code
16100
Country
Italy
12. IPD Sharing Statement
Plan to Share IPD
No
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Epidural Versus Wound Infusion Plus Morphine Bolus in Open Abdominal Aortic Aneurysm Repair
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