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.
Open major abdominal surgery is one of the most risky surgical procedures performed under general anaesthesia (GA) for inappropriate postoperative pain perception (IPPP), whereas thoracic epidural analgesia (TEA) still constitutes the golden standard of analgesic regimen in the upper abdomen because its was proven to provide improved postoperative analgesia, reduce the incidence of chronic postoperative pain, as compared with parenteral opioids. Therefore, it should always be considered as a routine adjunct to GA for elective open lumbar infrarenal aortic repair (OLIAAR). Monitors of analgesia that measure nociception / antinociception balance - intensity of nociception (painful stimulation) and efficacy of anti-nociception (pain relief) - are increasingly gaining popularity. The Adequacy o Anesthesia (AoA) concept is based on monitoring the depth of GA detected from a forehead sensor using an entropy electroencephalogram (Response Entropy, RE; State Entropy, SE) and the surgical pleth index (SPI) derived from a finger photoplethysmography signal, both of which do not require complex preoperative preparations Observance of the SE value within the range of 40-60 as a result of proper administration of the hypnotic GA component, reflecting the proper suppression of the limbic system, alongside observance of the increase in the SPI value on the monitor (0-no painful stimulation, 100-maximum painful stimulation) after a painful stimulus and returning to the baseline level after the intravenous rescue opioid analgesia (IROA) bolus (anti-nociception), makes the monitoring with AoA guidance easy SPI has been successfully used to monitor analgesia intra- and postoperatively and less postoperative pain have already been reported, when SPI monitoring was employed. Considering all the above, the investigators designed a randomised controlled study to assess the effect of TEA using a combination of either 0,2 % ropivacaine (RPV) and fentanyl (FNT) or 0,2% bupivacaine (BPV) and FNT on intra- and postoperative demand for opioids, haemodynamic stability as compared to intravenous preventive analgesia using metamizole/tramadol in patients undergoing open lumbar infrarenal aortic aneurysm repair (OLIAAR) under AoA-guided GA
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
75
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)
Medical University of Silesia
Sosnowiec, Silesian Voivodeship, Poland
pain perception intraoperatively
the investigators will compare the efficacy of preventive analgesia intraoperatively according to used preoperatively either intravenous or thoracic epidural infusions . The investigators will administer a rescue dose of fentanyl intravenously in a dose of 1 mcg per kg of body weight in the case when SPI (surgical pleth index) value increases over delta15 points in SPI scale every 5 minutes until SPI value decreases back to baseline value. Additionally, the investigators will analyse rescue fentanyl consumption in abovementioned groups
Time frame: from the skin incision till placement of last suture by the operator, an average of 2 hours
pain perception postoperatively
The investigators will compare the efficacy of analgesia postoperatively according to technique of analgesia used preoperatively: intravenous infusion of either metamizol/tramadol or thoracic epidural either 0,2% ropivacaine or bupivacaine with fentanyl. The investigators use NPRS (numeric pain rating score 0: no pain - 10: worst possible pain perception) and compare it with SPI values (0: most efficient antinociception-100; worst possible antinociception ).
Time frame: from extubation in the operating theatre until discharge to department of vascular surgery, but not shorter than half an hour
PONV (postoperative nausea and vomiting)
The investigators will compare the presence of PONV (scale 0 - no PONV;1 - presence of PONV) after emergence from GA in studied groups. The investigators will observe patients postoperatively for two days and record any incidence of nausea or vomiting and in the abovementioned case the investigators will administer a standard dose of antiemetic drug.
Time frame: 48 hours
haemodynamic stability
the investigators will observe and note the values of heart rate (HR \> 100: tachycardia; \< 45: bradycardia) and blood pressure (MAP: mean arterial pressure \< 65 mmHg intraoperative hypotension; DAP diastolic arterial pressure \> 110mmHg: malignant hypertension)
Time frame: from the beginning of induction of anaesthesia till discharge to department of vascular surgery, on average several hours
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