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

Postoperative Pain Clinical Trial

— APERIVIP  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02677532
• Other study ID #: APERIVIP
• Status: Completed
• Phase: Phase 4
• First received: January 29, 2016
• Last updated: February 8, 2016
• Start date: December 2011
• Est. completion date: January 2014

Study information

• Verified date: February 2016
• Source: University of Genova
• Contact: n/a
• Is FDA regulated: No
• Health authority: Italy: Ethics Committee
• Study type: Interventional

Clinical 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 repair.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 51
• Est. completion date: January 2014
• Est. primary completion date: November 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Pain, Postoperative
• Postoperative Pain

Intervention

Drug:
• Paracetamol
1 g every 8 hours
• Levobupivacaine wound infiltration
Wound infiltration with 10 ml levobupivacaine 0.5%
• Levobupivacaine epidural bolus
Epidural bolus of 10 ml 0.25% levobupivacaine
• Sufentanil epidural bolus
Epidural bolus of 0.15 mcg/kg sufentanil
• Morphine
Intravenous slow bolus of 10 mg morphine

Device:
• Epidural catheter placement
Thoracic epidural catheter placement in the T7-T8 or T8-T9 intervertebral space
• Wound infusion catheters placement
Pre-peritoneal placement of two catheters for wound infusion

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

Locations

Country	Name	City	State
Italy	UO Anestesia e Terapia Intensiva, IRCCS AOU San-Martino IST	Genova

Sponsors (1)

Lead Sponsor	Collaborator
University of Genova

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Incidence of postoperative cardiovascular adverse events		Intra-hospital follow-up of up to 3 months after surgery	Yes
Other	Incidence of postoperative pulmonary complications		Intra-hospital follow-up of up to 3 months after surgery	Yes
Primary	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)	No
Secondary	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	No
Secondary	Number of patients requiring oxygen administration at each time-point		0, 4, 8, 12, 24, 36, 48 hours after emergence from general anaesthesia	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	Yes
Secondary	Length of hospital stay		Follow-up of up to 3 months after surgery	No
Secondary	Heart rate (bpm) at each time-point		0, 4, 8, 12, 24, 36, 48 hours after emergence from general anaesthesia	No
Secondary	Incidence of postoperative nausea and vomiting		0, 4, 8, 12, 24, 36, 48 hours after emergence from general anaesthesia	No