Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 2 of 2 for:    "Aortic Aneurysm" | "Sufentanil"

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02677532
Recruitment Status : Completed
First Posted : February 9, 2016
Last Update Posted : February 9, 2016
Sponsor:
Information provided by (Responsible Party):
Paolo Pelosi, University of Genova

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.

Condition or disease Intervention/treatment Phase
Postoperative Pain Drug: Paracetamol Drug: Levobupivacaine wound infiltration Drug: Levobupivacaine epidural bolus Drug: Sufentanil epidural bolus Drug: Morphine Device: Epidural catheter placement Device: Wound infusion catheters placement Drug: Levobupivacaine plus sufentanil epidural infusion Drug: Levobupivacaine wound infusion Phase 4

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 51 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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 Start Date : December 2011
Actual Primary Completion Date : November 2013
Actual Study Completion Date : January 2014

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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




Primary Outcome Measures :
  1. 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 Measures :
  1. 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

  2. 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 ]
  3. 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

  4. 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

  5. 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 ]
  6. 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)

  7. Length of hospital stay [ Time Frame: Follow-up of up to 3 months after surgery ]
  8. Heart rate (bpm) at each time-point [ Time Frame: 0, 4, 8, 12, 24, 36, 48 hours after emergence from general anaesthesia ]
  9. Incidence of postoperative nausea and vomiting [ Time Frame: 0, 4, 8, 12, 24, 36, 48 hours after emergence from general anaesthesia ]

Other Outcome Measures:
  1. Incidence of postoperative cardiovascular adverse events [ Time Frame: Intra-hospital follow-up of up to 3 months after surgery ]
  2. Incidence of postoperative pulmonary complications [ Time Frame: Intra-hospital follow-up of up to 3 months after surgery ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02677532


Locations
Layout table for location information
Italy
UO Anestesia e Terapia Intensiva, IRCCS AOU San-Martino IST
Genova, Italy, 16100
Sponsors and Collaborators
University of Genova

Layout table for additonal information
Responsible Party: Paolo Pelosi, Professor, University of Genova
ClinicalTrials.gov Identifier: NCT02677532     History of Changes
Other Study ID Numbers: APERIVIP
First Posted: February 9, 2016    Key Record Dates
Last Update Posted: February 9, 2016
Last Verified: February 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Sufentanil
Pain, Postoperative
Postoperative Complications
Pathologic Processes
Pain
Neurologic Manifestations
Signs and Symptoms
Morphine
Levobupivacaine
Analgesics, Opioid
Narcotics
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Adjuvants, Anesthesia
Anesthetics, Intravenous
Anesthetics, General
Anesthetics
Anesthetics, Local