Epidural Versus Wound Infusion Plus Morphine Bolus in Open Abdominal Aortic Aneurysm Repair
Phase 4
Completed
- Conditions
- Postoperative Pain
- Interventions
- Device: Epidural catheter placementDevice: Wound infusion catheters placement
- Registration Number
- NCT02677532
- Lead Sponsor
- University of Genova
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 51
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
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Epidural infusion Levobupivacaine epidural bolus 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. Epidural infusion Epidural catheter placement 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. Wound infusion plus morphine bolus Levobupivacaine wound infiltration 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. Wound infusion plus morphine bolus Wound infusion catheters placement 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. Epidural infusion Levobupivacaine plus sufentanil epidural infusion 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. Wound infusion plus morphine bolus Paracetamol 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. Wound infusion plus morphine bolus Levobupivacaine wound infusion 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. Epidural infusion Sufentanil epidural bolus 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. Epidural infusion Paracetamol 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. Wound infusion plus morphine bolus Morphine 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.
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method Length of hospital stay Follow-up of up to 3 months after surgery 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
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)
Incidence of postoperative nausea and vomiting 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
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 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
Trial Locations
- Locations (1)
UO Anestesia e Terapia Intensiva, IRCCS AOU San-Martino IST
🇮🇹Genova, Italy