Postoperative PainPhase 4APERIVIPNCT02677532
Epidural Versus Wound Infusion Plus Morphine Bolus in Open Abdominal Aortic Aneurysm Repair
A Phase 4 study testing Paracetamol, Levobupivacaine wound infiltration and Levobupivacaine epidural bolus in people with Postoperative Pain, run by University of Genova at 1 site in Italy.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Postoperative Pain
- What is being tested?
- Paracetamol, Levobupivacaine wound infiltration and Levobupivacaine epidural bolus
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 51 participants
- Where
- 1 siteItaly
- Study dates
- Dec 2011to Jan 2014
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Scheduled for elective open aortic aneurism repair
Who cannot join
- 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 locations and contacts
1 site in 1 country.
Italy1 site
UO Anestesia e Terapia Intensiva, IRCCS AOU San-Martino IST
Genova, Genova, 16100
About this study
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
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
- Being tested
- Paracetamol, Levobupivacaine wound infiltration, Levobupivacaine epidural bolus, Sufentanil epidural bolus, Morphine
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ParacetamolDrug
1 g every 8 hours
Levobupivacaine wound infiltrationDrug
Wound infiltration with 10 ml levobupivacaine 0.5%
Levobupivacaine epidural bolusDrug
Epidural bolus of 10 ml 0.25% levobupivacaine
Sufentanil epidural bolusDrug
Epidural bolus of 0.15 mcg/kg sufentanil
MorphineDrug
Intravenous slow bolus of 10 mg morphine
Epidural catheter placementDevice
Thoracic epidural catheter placement in the T7-T8 or T8-T9 intervertebral space
Wound infusion catheters placementDevice
Pre-peritoneal placement of two catheters for wound infusion
Levobupivacaine plus sufentanil epidural infusionDrug
Epidural infusion of levobupivacaine 0.12% plus sufentanil 0.4 mcg/ml at 4 ml/h for 48 h
Levobupivacaine wound infusionDrug
Wound infusion with levobupivacaine 0.25% at 4 ml/h for 48 h
| Study group | Role | What they receive |
|---|---|---|
| Epidural infusion | Active comparator | 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. Receives: Drug: Paracetamol; Drug: Levobupivacaine epidural bolus; Drug: Sufentanil epidural bolus; Device: Epidural catheter placement; Drug: Levobupivacaine plus sufentanil epidural infusion |
| Wound infusion plus morphine bolus | Experimental | 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. Receives: Drug: Paracetamol; Drug: Levobupivacaine wound infiltration; Drug: Morphine; Device: Wound infusion catheters placement; Drug: Levobupivacaine wound infusion |
What is being measured
The primary outcome is the main question the study is designed to answer.
Average postoperative pain assessed with numeric rating scale (NRS) in the first 48 hours
Measured: Average of the NRS recorded at the different time-points (up to 48 hours after emergence from general anaesthesia)
Secondary outcomes (9)
Need for rescue doses of morphine at each time-point
Need for a bolus of 5 mg intravenous morphine to relief pain
Measured: 0, 4, 8, 12, 24, 36, 48 hours after emergence from general anaesthesia
Number of patients requiring oxygen administration at each time-point
Measured: 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 to first stool analysis
Measured: 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 to catheter removal analysis
Measured: 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
Measured: 0, 4, 8, 12, 24, 36, 48 hours after emergence from general anaesthesia
Non-invasive blood pressure (mmHg) at each time-point
Blood pressure (systolic, diastolic, mean in mmHg)
Measured: 0, 4, 8, 12, 24, 36, 48 hours after emergence from general anaesthesia
Length of hospital stay
Measured: Follow-up of up to 3 months after surgery
Heart rate (bpm) at each time-point
Measured: 0, 4, 8, 12, 24, 36, 48 hours after emergence from general anaesthesia
Incidence of postoperative nausea and vomiting
Measured: 0, 4, 8, 12, 24, 36, 48 hours after emergence from general anaesthesia
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Feb 2016 (estimated)
- Study startDec 2011
- Primary completionNov 2013
- Study completionJan 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postoperative PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 51 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Genova
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Paolo Pelosi, University of Genova
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02677532
- Sponsor's protocol ID
- APERIVIP
- Acronym
- APERIVIP
- Status last verified
- Feb 2016
- First submitted
- 29 Jan 2016
- Last updated
- 9 Feb 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Feb 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02677532
- Acronym / sponsor ID
- APERIVIP / APERIVIP
- Conditions
- Postoperative Pain
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 51 participants (actual)
- Lead sponsor
- University of GenovaUniversity, hospital or other
- Study start
- Dec 2011
- Primary completion
- Nov 2013 (actual)
- Study completion
- Jan 2014 (actual)
- First posted
- 9 Feb 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Epidural infusion | Active comparator | Drug: Paracetamol, Drug: Levobupivacaine epidural bolus, Drug: Sufentanil epidural bolus, Device: Epidural catheter placement, Drug: Levobupivacaine plus sufentanil epidural infusionThoracic 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. |
| Wound infusion plus morphine bolus | Experimental | Drug: Paracetamol, Drug: Levobupivacaine wound infiltration, Drug: Morphine, Device: Wound infusion catheters placement, Drug: Levobupivacaine wound infusionIntravenous 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Scheduled for elective open aortic aneurism repair
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Paracetamol1 g every 8 hours | Drug | Epidural infusion, Wound infusion plus morphine bolus |
| Levobupivacaine wound infiltrationWound infiltration with 10 ml levobupivacaine 0.5% | Drug | Wound infusion plus morphine bolus |
| Levobupivacaine epidural bolusEpidural bolus of 10 ml 0.25% levobupivacaine | Drug | Epidural infusion |
| Sufentanil epidural bolusEpidural bolus of 0.15 mcg/kg sufentanil | Drug | Epidural infusion |
| MorphineIntravenous slow bolus of 10 mg morphine | Drug | Wound infusion plus morphine bolus |
| Epidural catheter placementThoracic epidural catheter placement in the T7-T8 or T8-T9 intervertebral space | Device | Epidural infusion |
| Wound infusion catheters placementPre-peritoneal placement of two catheters for wound infusion | Device | Wound infusion plus morphine bolus |
| Levobupivacaine plus sufentanil epidural infusionEpidural infusion of levobupivacaine 0.12% plus sufentanil 0.4 mcg/ml at 4 ml/h for 48 h | Drug | Epidural infusion |
| Levobupivacaine wound infusionWound infusion with levobupivacaine 0.25% at 4 ml/h for 48 h | Drug | Wound infusion plus morphine bolus |
Primary outcome
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)
9 secondary outcomes
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
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
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
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
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
Non-invasive blood pressure (mmHg) at each time-point
Time frame: 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
Heart rate (bpm) at each time-point
Time frame: 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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Feb 2016.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Paracetamol, Levobupivacaine wound infiltration and Levobupivacaine epidural bolus in people with Postoperative Pain, run by University of Genova at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Feb 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Feb 2016.