Clinical trial NCT02677532: Epidural Versus Wound Infusion Plus Morphine Bolus in Open Abdominal Aortic Aneurysm Repair
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Postoperative Pain
Lead sponsor: University of Genova
Sponsor class: OTHER
First posted: 2016-02-09
Enrollment: 51
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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

Primary outcomes:
measure: Average postoperative pain assessed with numeric rating scale (NRS) in the first 48 hours
timeFrame: Average of the NRS recorded at the different time-points (up to 48 hours after emergence from general anaesthesia)
Secondary outcomes:
measure: Need for rescue doses of morphine at each time-point
timeFrame: 0, 4, 8, 12, 24, 36, 48 hours after emergence from general anaesthesia
measure: Number of patients requiring oxygen administration at each time-point
timeFrame: 0, 4, 8, 12, 24, 36, 48 hours after emergence from general anaesthesia
measure: Number of patients that have restored bowel function at each time-point
timeFrame: 0, 4, 8, 12, 24, 36, 48 hours after emergence from general anaesthesia
measure: Number of patients whose urinary catheter was removed at each time-point
timeFrame: 0, 4, 8, 12, 24, 36, 48 hours after emergence from general anaesthesia
measure: Number of patients that have restored ability to walk at each time-point
timeFrame: 0, 4, 8, 12, 24, 36, 48 hours after emergence from general anaesthesia
measure: Non-invasive blood pressure (mmHg) at each time-point
timeFrame: 0, 4, 8, 12, 24, 36, 48 hours after emergence from general anaesthesia
measure: Length of hospital stay
timeFrame: Follow-up of up to 3 months after surgery
measure: Heart rate (bpm) at each time-point
timeFrame: 0, 4, 8, 12, 24, 36, 48 hours after emergence from general anaesthesia
measure: Incidence of postoperative nausea and vomiting
timeFrame: 0, 4, 8, 12, 24, 36, 48 hours after emergence from general anaesthesia
Other outcomes:
measure: Incidence of postoperative cardiovascular adverse events
timeFrame: Intra-hospital follow-up of up to 3 months after surgery
measure: Incidence of postoperative pulmonary complications
timeFrame: Intra-hospital follow-up of up to 3 months after surgery
Locations:
city: Genova
country: Italy
facility: UO Anestesia e Terapia Intensiva, IRCCS AOU San-Martino IST
Study officials:
References: