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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
51
1 g every 8 hours
Wound infiltration with 10 ml levobupivacaine 0.5%
Epidural bolus of 10 ml 0.25% levobupivacaine
UO Anestesia e Terapia Intensiva, IRCCS AOU San-Martino IST
Genova, Genova, Italy
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)
Need for rescue doses of morphine at each time-point
Need for a bolus of 5 mg intravenous morphine to relief pain
Time frame: 0, 4, 8, 12, 24, 36, 48 hours after emergence from general anaesthesia
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
Number of patients that have restored bowel function at each time-point
Time to first stool analysis
Time frame: 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
Time frame: 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
Time frame: 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)
Time frame: 0, 4, 8, 12, 24, 36, 48 hours after emergence from general anaesthesia
Length of hospital stay
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Epidural bolus of 0.15 mcg/kg sufentanil
Intravenous slow bolus of 10 mg morphine
Thoracic epidural catheter placement in the T7-T8 or T8-T9 intervertebral space
Pre-peritoneal placement of two catheters for wound infusion
Epidural infusion of levobupivacaine 0.12% plus sufentanil 0.4 mcg/ml at 4 ml/h for 48 h
Wound infusion with levobupivacaine 0.25% at 4 ml/h for 48 h
Time frame: Follow-up of up to 3 months after surgery
Heart rate (bpm) at each time-point
Time frame: 0, 4, 8, 12, 24, 36, 48 hours after emergence from general anaesthesia
Incidence of postoperative nausea and vomiting
Time frame: 0, 4, 8, 12, 24, 36, 48 hours after emergence from general anaesthesia