Skip to main content
OpenTrials
Completed

NCT Number: NCT02677532

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Postoperative Pain Neurologic Manifestations Pain Pain, Postoperative Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

UO Anestesia e Terapia Intensiva, IRCCS AOU San-Martino IST

Genova, 16100, Italy

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Paracetamol

Drug

1 g every 8 hours

Levobupivacaine wound infiltration

Drug

Wound infiltration with 10 ml levobupivacaine 0.5%

Levobupivacaine epidural bolus

Drug

Epidural bolus of 10 ml 0.25% levobupivacaine

Sufentanil epidural bolus

Drug

Epidural bolus of 0.15 mcg/kg sufentanil

Morphine

Drug

Intravenous slow bolus of 10 mg morphine

epidural catheter placement

Device

Thoracic epidural catheter placement in the T7-T8 or T8-T9 intervertebral space

Wound infusion catheters placement

Device

Pre-peritoneal placement of two catheters for wound infusion

Levobupivacaine plus sufentanil epidural infusion

Drug

Epidural infusion of levobupivacaine 0.12% plus sufentanil 0.4 mcg/ml at 4 ml/h for 48 h

Levobupivacaine wound infusion

Drug

Wound infusion with levobupivacaine 0.25% at 4 ml/h for 48 h

Primary outcomes

  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 outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

University of Genova

Other

Registry information

Official study 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

Acronym: APERIVIP

Important dates

Study start
2011
Primary completion
2013
Study completion
2014
First posted
Feb 9, 2016
Registry last updated
Feb 9, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.