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
Overview
- Phase
- Phase 4
- Intervention
- Paracetamol
- Conditions
- Postoperative Pain
- Sponsor
- University of Genova
- Enrollment
- 51
- Locations
- 1
- Primary Endpoint
- Average postoperative pain assessed with numeric rating scale (NRS) in the first 48 hours
- Status
- Completed
- Last Updated
- 10 years ago
Overview
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.
Investigators
Paolo Pelosi
Professor
University of Genova
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
Arms & Interventions
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.
Intervention: Paracetamol
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.
Intervention: Levobupivacaine epidural bolus
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.
Intervention: Sufentanil epidural bolus
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.
Intervention: Epidural catheter placement
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.
Intervention: Levobupivacaine plus sufentanil epidural infusion
Wound infusion plus morphine bolus
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.
Intervention: Paracetamol
Wound infusion plus morphine bolus
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.
Intervention: Levobupivacaine wound infiltration
Wound infusion plus morphine bolus
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.
Intervention: Morphine
Wound infusion plus morphine bolus
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.
Intervention: Wound infusion catheters placement
Wound infusion plus morphine bolus
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.
Intervention: Levobupivacaine wound infusion
Outcomes
Primary Outcomes
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)
Secondary Outcomes
- 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)
- Non-invasive blood pressure (mmHg) 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)
- 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)
- Need for rescue doses of morphine at each time-point(0, 4, 8, 12, 24, 36, 48 hours after emergence from general anaesthesia)
- 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)