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

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: Completed
• Conditions: Postoperative Pain
• Intervention / Treatment: Drug: Paracetamol; Drug: Levobupivacaine epidural bolus; Drug: Sufentanil epidural bolus; Device: Epidural catheter placement; Drug: Levobupivacaine plus sufentanil epidural infusion; Drug: Levobupivacaine wound infiltration; Drug: Morphine; Device: Wound infusion catheters placement; Drug: Levobupivacaine wound infusion

• Study Type: Interventional
• Enrollment (Actual): 51
• Phase: Phase 4

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• 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

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Average postoperative pain assessed with numeric rating scale (NRS) in the first 48 hours	Average of the NRS recorded at the different time-points (up to 48 hours after emergence from general anaesthesia)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Need for rescue doses of morphine at each time-point	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		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	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	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		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)	0, 4, 8, 12, 24, 36, 48 hours after emergence from general anaesthesia
Length of hospital stay		Follow-up of up to 3 months after surgery
Heart rate (bpm) at each time-point		0, 4, 8, 12, 24, 36, 48 hours after emergence from general anaesthesia
Incidence of postoperative nausea and vomiting		0, 4, 8, 12, 24, 36, 48 hours after emergence from general anaesthesia

Other Outcome Measures

Outcome Measure	Time Frame
Incidence of postoperative cardiovascular adverse events	Intra-hospital follow-up of up to 3 months after surgery
Incidence of postoperative pulmonary complications	Intra-hospital follow-up of up to 3 months after surgery

Collaborators and Investigators

• Sponsor: University of Genova

Study record dates

Study Major Dates

• Study Start: December 1, 2011
• Primary Completion (Actual): November 1, 2013
• Study Completion (Actual): January 1, 2014

Study Registration Dates

• First Submitted: January 29, 2016
• First Submitted That Met QC Criteria: February 8, 2016
• First Posted (Estimate): February 9, 2016

Study Record Updates

• Last Update Posted (Estimate): February 9, 2016
• Last Update Submitted That Met QC Criteria: February 8, 2016
• Last Verified: February 1, 2016

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Pain; Neurologic Manifestations; Pain, Postoperative; Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Anesthetics, Intravenous; Anesthetics, General; Anesthetics; Analgesics, Non-Narcotic; Antipyretics; Analgesics, Opioid; Narcotics; Adjuvants, Anesthesia; Anesthetics, Local; Acetaminophen; Morphine; Levobupivacaine; Sufentanil; Dsuvia
• Other Study ID Numbers: APERIVIP

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO