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

February 8, 2016 updated by: Paolo Pelosi, University of Genova

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
51

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
      • Genova, Italy, 16100
        • UO Anestesia e Terapia Intensiva, IRCCS AOU San-Martino IST

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Active Comparator: 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.
Drug: Paracetamol
1 g every 8 hours
Drug: Levobupivacaine epidural bolus
Epidural bolus of 10 ml 0.25% levobupivacaine
Drug: Sufentanil epidural bolus
Epidural bolus of 0.15 mcg/kg sufentanil
Device: Epidural catheter placement
Thoracic epidural catheter placement in the T7-T8 or T8-T9 intervertebral space
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
Experimental: 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.
Drug: Paracetamol
1 g every 8 hours
Drug: Levobupivacaine wound infiltration
Wound infiltration with 10 ml levobupivacaine 0.5%
Drug: Morphine
Intravenous slow bolus of 10 mg morphine
Device: Wound infusion catheters placement
Pre-peritoneal placement of two catheters for wound infusion
Drug: Levobupivacaine wound infusion
Wound infusion with levobupivacaine 0.25% at 4 ml/h for 48 h

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
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)
Average of the NRS recorded at the different time-points (up to 48 hours after emergence from general anaesthesia)

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Need for rescue doses of morphine at each time-point
Time Frame: 0, 4, 8, 12, 24, 36, 48 hours after emergence from general anaesthesia
Need for a bolus of 5 mg intravenous morphine to relief pain
0, 4, 8, 12, 24, 36, 48 hours after emergence from general anaesthesia
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
0, 4, 8, 12, 24, 36, 48 hours after emergence from general anaesthesia
Number of patients that have restored bowel function at each time-point
Time Frame: 0, 4, 8, 12, 24, 36, 48 hours after emergence from general anaesthesia
Time to first stool analysis
0, 4, 8, 12, 24, 36, 48 hours after emergence from general anaesthesia
Number of patients whose urinary catheter was removed at each time-point
Time Frame: 0, 4, 8, 12, 24, 36, 48 hours after emergence from general anaesthesia
Time to catheter removal analysis
0, 4, 8, 12, 24, 36, 48 hours after emergence from general anaesthesia
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
0, 4, 8, 12, 24, 36, 48 hours after emergence from general anaesthesia
Non-invasive blood pressure (mmHg) at each time-point
Time Frame: 0, 4, 8, 12, 24, 36, 48 hours after emergence from general anaesthesia
Blood pressure (systolic, diastolic, mean in mmHg)
0, 4, 8, 12, 24, 36, 48 hours after emergence from general anaesthesia
Length of hospital stay
Time Frame: Follow-up of up to 3 months after surgery
Follow-up of up to 3 months after surgery
Heart rate (bpm) at each time-point
Time Frame: 0, 4, 8, 12, 24, 36, 48 hours after emergence from general anaesthesia
0, 4, 8, 12, 24, 36, 48 hours after emergence from general anaesthesia
Incidence of postoperative nausea and vomiting
Time Frame: 0, 4, 8, 12, 24, 36, 48 hours after emergence from general anaesthesia
0, 4, 8, 12, 24, 36, 48 hours after emergence from general anaesthesia

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Time Frame
Incidence of postoperative cardiovascular adverse events
Time Frame: Intra-hospital follow-up of up to 3 months after surgery
Intra-hospital follow-up of up to 3 months after surgery
Incidence of postoperative pulmonary complications
Time Frame: Intra-hospital follow-up of up to 3 months after surgery
Intra-hospital follow-up of up to 3 months after surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Genova

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 1, 2011

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
November 1, 2013

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 1, 2014

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 29, 2016

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 8, 2016

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 9, 2016

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 9, 2016

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 8, 2016

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • APERIVIP

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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