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

NCT02677532 | Completed Phase 4

• 1 other identifier: APERIVIP
• Study Type: interventional
• Target: 51
• Locations: 1 country
• Sites: 1

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.

Conditions

Postoperative Pain

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (9)

• Need for rescue doses of morphine at each time-point

  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

  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

  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

Other Outcomes (2)

• 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

Study Arms (2)

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.

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.

Drug: Paracetamol; Drug: Levobupivacaine wound infiltration; Drug: Morphine; Device: Wound infusion catheters placement; Drug: Levobupivacaine wound infusion

Interventions

Paracetamol DRUG

1 g every 8 hours

Epidural infusion; Wound infusion plus morphine bolus

Levobupivacaine wound infiltration DRUG

Wound infiltration with 10 ml levobupivacaine 0.5%

Wound infusion plus morphine bolus

Levobupivacaine epidural bolus DRUG

Epidural bolus of 10 ml 0.25% levobupivacaine

Epidural infusion

Sufentanil epidural bolus DRUG

Epidural bolus of 0.15 mcg/kg sufentanil

Epidural infusion

Morphine DRUG

Intravenous slow bolus of 10 mg morphine

Wound infusion plus morphine bolus

Epidural catheter placement DEVICE

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

Epidural infusion

Wound infusion catheters placement DEVICE

Pre-peritoneal placement of two catheters for wound infusion

Wound infusion plus morphine bolus

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

Epidural infusion

Levobupivacaine wound infusion DRUG

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

Wound infusion plus morphine bolus

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Scheduled for elective open aortic aneurism repair

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Genova: lead

Study Sites (1)

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

Genova, Genova, 16100, Italy

Location

MeSH Terms

Conditions

Pain, Postoperative

Interventions

Acetaminophen; Morphine; Levobupivacaine

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Acetanilides; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Morphine Derivatives; Morphinans; Opiate Alkaloids; Alkaloids; Heterocyclic Compounds; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Phenanthrenes; Polycyclic Aromatic Hydrocarbons; Polycyclic Compounds; Bupivacaine

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: January 29, 2016
• First Posted: February 9, 2016
• Study Start: December 1, 2011
• Primary Completion: November 1, 2013
• Study Completion: January 1, 2014
• Last Updated: February 9, 2016

Record last verified: 2016-02

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)