Postoperative Pain
Conditions
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.
Interventions
Thoracic epidural catheter placement in the T7-T8 or T8-T9 intervertebral space
DRUGParacetamol
1 g every 8 hours
DRUGLevobupivacaine wound infiltration
Wound infiltration with 10 ml levobupivacaine 0.5%
DRUGLevobupivacaine epidural bolus
Epidural bolus of 10 ml 0.25% levobupivacaine
DRUGSufentanil epidural bolus
Epidural bolus of 0.15 mcg/kg sufentanil
DRUGMorphine
Intravenous slow bolus of 10 mg morphine
DEVICEWound infusion catheters placement
Pre-peritoneal placement of two catheters for wound infusion
DRUGLevobupivacaine plus sufentanil epidural infusion
Epidural infusion of levobupivacaine 0.12% plus sufentanil 0.4 mcg/ml at 4 ml/h for 48 h
DRUGLevobupivacaine wound infusion
Wound infusion with levobupivacaine 0.25% at 4 ml/h for 48 h
Sponsors
University of Genova
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| 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
| Measure | Time frame | Description |
|---|---|---|
| Need for rescue doses of morphine at each time-point | 0, 4, 8, 12, 24, 36, 48 hours after emergence from general anaesthesia | Need for a bolus of 5 mg intravenous morphine to relief pain |
| 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 | Time to first stool analysis |
| 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 | Time to catheter removal analysis |
| 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 | — |
| 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 | — |
| Non-invasive blood pressure (mmHg) at each time-point | 0, 4, 8, 12, 24, 36, 48 hours after emergence from general anaesthesia | Blood pressure (systolic, diastolic, mean in mmHg) |
| Length of hospital stay | Follow-up of up to 3 months after surgery | — |
Other
| 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 |
Countries
Italy
Outcome results
None listed