Trials / Completed
CompletedNCT06609993
AoA Guided Thoracic Epidural Analgesia for Abdominal Aortic Repair
Thoracic Epidural Analgesia Using Bupivacaine or Ropivacaine With Fentanyl in Patients Undergoing Abdominal Aorctic Repair Under Adequacy of Anaestesia Guidance
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 75 (actual)
- Sponsor
- Michał Stasiowski · Academic / Other
- Sex
- All
- Age
- 18 Years – 80 Years
- Healthy volunteers
- Not accepted
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.
Detailed description
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
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | intravenous rescue opioid analgesia using fentanyl | intraoperative rescue opioid analgesia using 1mcg/kg of fentanyl (Fentanyl WZF, POlfa Warsawa, Poland) )/ body weight when SPI value \> 15 baseline |
| DRUG | intravenous rescue atropine administration | atropine (Atropinum Sulfuricum WZF, POlfa Warsawa, Poland) in a dose of 0,5mg/kg of will be administered intravenously when heart rate \< 50 |
| DRUG | intravenous rescue urapidil administration | urapidil (Ebrantil 25, Takeda PHARMA, Japan) in a dose of 10 mg will be administered intravenously when DAP \> 110 mmHg or SAP \> 200 mmHg |
| DRUG | intravenous rescue ephedrine administration | 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 |
| BIOLOGICAL | concentrate of red blood cells | concentrate of red blood cells will be transfused when concentration of haemoglobin \< 10g% |
| BIOLOGICAL | red blood cells autotransfusion | red blood cells from the operation site will be retransfused using cell saver |
| DRUG | primary treatment of postoperative nausea and vomiting (PONV) | dexamethasone ((Dexaven 4mg/ml, Jelfa, Poland) in a dose of 4 mg will be administered intravenously when incidence of PONV is observed |
| DRUG | secondary treatment of postoperative nausea and vomiting (PONV) | 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 |
| DRUG | intraopertative fluid challenge (IFC) | 3 mililitre of synthetic colloid will be transfused intravenously per each sudden blood loss of 1 mililitre |
| DRUG | postoperative rescue opioid analgesia using morphine | 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) |
Timeline
- Start date
- 2017-12-12
- Primary completion
- 2020-03-31
- Completion
- 2020-03-31
- First posted
- 2024-09-24
- Last updated
- 2024-09-24
Locations
1 site across 1 country: Poland
Source: ClinicalTrials.gov record NCT06609993. Inclusion in this directory is not an endorsement.