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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Epidural infusion | Active Comparator | 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 | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Paracetamol | Drug | 1 g every 8 hours |
| |
| Measure | Description | 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) |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Number of patients requiring oxygen administration at each time-point |
| Measure | Description | 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 |
Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UO Anestesia e Terapia Intensiva, IRCCS AOU San-Martino IST | Genova | Genova | 16100 | Italy |
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| Levobupivacaine wound infiltration |
| Drug |
Wound infiltration with 10 ml levobupivacaine 0.5% |
|
| Levobupivacaine epidural bolus | Drug | Epidural bolus of 10 ml 0.25% levobupivacaine |
|
| Sufentanil epidural bolus | Drug | Epidural bolus of 0.15 mcg/kg sufentanil |
|
| Morphine | Drug | Intravenous slow bolus of 10 mg morphine |
|
| Epidural catheter placement | Device | Thoracic epidural catheter placement in the T7-T8 or T8-T9 intervertebral space |
|
| Wound infusion catheters placement | Device | Pre-peritoneal placement of two catheters for wound infusion |
|
| Levobupivacaine plus sufentanil epidural infusion | Drug | Epidural infusion of levobupivacaine 0.12% plus sufentanil 0.4 mcg/ml at 4 ml/h for 48 h |
|
| Levobupivacaine wound infusion | Drug | Wound infusion with levobupivacaine 0.25% at 4 ml/h for 48 h |
|
| 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 | 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 | 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 |
| 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 |
| Length of hospital stay | Follow-up of up to 3 months after surgery |
| 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 |
| ID | Term |
|---|---|
| D010149 | Pain, Postoperative |
| ID | Term |
|---|---|
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
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| ID | Term |
|---|---|
| D000082 | Acetaminophen |
| D009020 | Morphine |
| D000077554 | Levobupivacaine |
| ID | Term |
|---|---|
| D000083 | Acetanilides |
| D000813 | Anilides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000814 | Aniline Compounds |
| D000588 | Amines |
| D009022 | Morphine Derivatives |
| D009019 | Morphinans |
| D053610 | Opiate Alkaloids |
| D000470 | Alkaloids |
| D006571 | Heterocyclic Compounds |
| D006572 | Heterocyclic Compounds, Bridged-Ring |
| D006576 | Heterocyclic Compounds, 4 or More Rings |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D010616 | Phenanthrenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D011083 | Polycyclic Compounds |
| D002045 | Bupivacaine |
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