At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Thoracic Epidural Analgesia Using Bupivacaine or Ropivacaine With Fentanyl in Patients Undergoing Abdominal Aorctic Repair Under Adequacy of Anaestesia Guidance
In Brief
A clinical study evaluating intravenous rescue opioid analgesia using fentanyl, intravenous rescue atropine administration, and 8 other interventions for Aortic Aneurysm and 3 related conditions. Completed, enrolled 75 participants across 1 site.
Detailed Summary
The aim of this randomized trial is to assess the efficacy of analgesia using either thoracic epidural or intravenous infusions for open lumbar infrarenal aortic aneurys repair and compare Numerical Rating Scale (NRS) with Surgical Pleth Index (SPI) for monitoring pain perception postoperatively. Patients received either preemptive thoracic epidural analgesia using either 0,2% ropivacaine with fentanyl or 0,2% bupivacaine with fenthanyl or preemptive intravenous infusion using metamizole and tramadol.
Study Details
Timeline
Interventions
intraoperative rescue opioid analgesia using 1mcg/kg of fentanyl (Fentanyl WZF, POlfa Warsawa, Poland) )/ body weight when SPI value \> 15 baseline
atropine (Atropinum Sulfuricum WZF, POlfa Warsawa, Poland) in a dose of 0,5mg/kg of will be administered intravenously when heart rate \< 50
urapidil (Ebrantil 25, Takeda PHARMA, Japan) in a dose of 10 mg will be administered intravenously when DAP \> 110 mmHg or SAP \> 200 mmHg
ephedrine (Ephedrinum Sulfuricum WZF, POlfa Warsawa, Poland) in a dose of 10 mg will be administered intravenously when DAP \< 50 mmHg or MAP \< 65 mmHg
concentrate of red blood cells will be transfused when concentration of haemoglobin \< 10g%
red blood cells from the operation site will be retransfused using cell saver
dexamethasone ((Dexaven 4mg/ml, Jelfa, Poland) in a dose of 4 mg will be administered intravenously when incidence of PONV is observed
Ondansetron (Ondansetron Accord 2mg/ml, 2 ml solution, Accord Healthcare Limited, Great Britain) in a dose of 4 mg will be administered intravenously when incidence of persistent PONV is observed despite the dexamethasone in a dose of 4 mg will be administration intravenously
3 mililitre of synthetic colloid will be transfused intravenously per each sudden blood loss of 1 mililitre
postoperative rescue opioid analgesia will be administered intravenously using 2 miligrams of morphine ((Morfini Sulfas WZF, 20mg/ml, solutio pro iniectione, Polfa Warszawa, Poland)every 10 minutes until postoperative pain perception using NPRS scale will decrease below 4 (NPRS; 0 meant no pain and 10 meant the worst pain imaginable)