AoA Guided Thoracic Epidural Analgesia for Abdominal Aortic Repair
- Conditions
- Aortic AneurysmPostoperative Nausea and VomitingPostoperative PainHaemodynamic Stability
- Interventions
- Drug: intravenous rescue opioid analgesia using fentanylDrug: intravenous rescue atropine administrationDrug: intravenous rescue urapidil administrationDrug: intravenous rescue ephedrine administrationBiological: concentrate of red blood cellsBiological: red blood cells autotransfusionDrug: primary treatment of postoperative nausea and vomiting (PONV)Drug: secondary treatment of postoperative nausea and vomiting (PONV)Drug: intraopertative fluid challenge (IFC)Drug: postoperative rescue opioid analgesia using morphine
- Registration Number
- NCT06609993
- Lead Sponsor
- Michał Stasiowski
- Brief 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
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 75
- written consent to participate in the study
- written consent to undergo general anaesthesia combined with different techniques of pre-emptive intravenous or thoracic epidural analgesia for aortic aneurysm repair
- antiplatelet therapy
- allergy to local anaesthetics, metamizole or tramadol
- necessity of administration of vasoactive drugs influencing SPI monitoring
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description thoracic epidural analgesia using 0,2% ropicavaine with fentanyl intravenous rescue opioid analgesia using fentanyl preventive analgesia will be assured using 0,2% ropicavaine (Ropivacaini Hydrochloridum 1%, 10mg/mL, 10 mL, Molteni Farmaceutici, Italy) with fentanyl via thoracic epidural catheter perioperatively thoracic epidural analgesia using 0,2% ropicavaine with fentanyl intravenous rescue atropine administration preventive analgesia will be assured using 0,2% ropicavaine (Ropivacaini Hydrochloridum 1%, 10mg/mL, 10 mL, Molteni Farmaceutici, Italy) with fentanyl via thoracic epidural catheter perioperatively thoracic epidural analgesia using 0,2% ropicavaine with fentanyl intravenous rescue urapidil administration preventive analgesia will be assured using 0,2% ropicavaine (Ropivacaini Hydrochloridum 1%, 10mg/mL, 10 mL, Molteni Farmaceutici, Italy) with fentanyl via thoracic epidural catheter perioperatively thoracic epidural analgesia using 0,2% ropicavaine with fentanyl intravenous rescue ephedrine administration preventive analgesia will be assured using 0,2% ropicavaine (Ropivacaini Hydrochloridum 1%, 10mg/mL, 10 mL, Molteni Farmaceutici, Italy) with fentanyl via thoracic epidural catheter perioperatively thoracic epidural analgesia using 0,2% ropicavaine with fentanyl concentrate of red blood cells preventive analgesia will be assured using 0,2% ropicavaine (Ropivacaini Hydrochloridum 1%, 10mg/mL, 10 mL, Molteni Farmaceutici, Italy) with fentanyl via thoracic epidural catheter perioperatively thoracic epidural analgesia using 0,2% ropicavaine with fentanyl red blood cells autotransfusion preventive analgesia will be assured using 0,2% ropicavaine (Ropivacaini Hydrochloridum 1%, 10mg/mL, 10 mL, Molteni Farmaceutici, Italy) with fentanyl via thoracic epidural catheter perioperatively thoracic epidural analgesia using 0,2% ropicavaine with fentanyl primary treatment of postoperative nausea and vomiting (PONV) preventive analgesia will be assured using 0,2% ropicavaine (Ropivacaini Hydrochloridum 1%, 10mg/mL, 10 mL, Molteni Farmaceutici, Italy) with fentanyl via thoracic epidural catheter perioperatively thoracic epidural analgesia using 0,2% ropicavaine with fentanyl secondary treatment of postoperative nausea and vomiting (PONV) preventive analgesia will be assured using 0,2% ropicavaine (Ropivacaini Hydrochloridum 1%, 10mg/mL, 10 mL, Molteni Farmaceutici, Italy) with fentanyl via thoracic epidural catheter perioperatively thoracic epidural analgesia using 0,2% ropicavaine with fentanyl intraopertative fluid challenge (IFC) preventive analgesia will be assured using 0,2% ropicavaine (Ropivacaini Hydrochloridum 1%, 10mg/mL, 10 mL, Molteni Farmaceutici, Italy) with fentanyl via thoracic epidural catheter perioperatively thoracic epidural analgesia using 0,2% ropicavaine with fentanyl postoperative rescue opioid analgesia using morphine preventive analgesia will be assured using 0,2% ropicavaine (Ropivacaini Hydrochloridum 1%, 10mg/mL, 10 mL, Molteni Farmaceutici, Italy) with fentanyl via thoracic epidural catheter perioperatively thoracic epidural analgesia using 0,2% bupicavaine with fentanyl intravenous rescue opioid analgesia using fentanyl preventive analgesia will be assured using 0,2% bupicavaine (Bupivacainum Hydrochloricum WZF 0.5%, 5 mg/mL, 10 mL, Polfa Warszawa S.A, Warsaw, Poland) with fentanyl via thoracic epidural catheter perioperatively thoracic epidural analgesia using 0,2% bupicavaine with fentanyl intravenous rescue atropine administration preventive analgesia will be assured using 0,2% bupicavaine (Bupivacainum Hydrochloricum WZF 0.5%, 5 mg/mL, 10 mL, Polfa Warszawa S.A, Warsaw, Poland) with fentanyl via thoracic epidural catheter perioperatively thoracic epidural analgesia using 0,2% bupicavaine with fentanyl intravenous rescue urapidil administration preventive analgesia will be assured using 0,2% bupicavaine (Bupivacainum Hydrochloricum WZF 0.5%, 5 mg/mL, 10 mL, Polfa Warszawa S.A, Warsaw, Poland) with fentanyl via thoracic epidural catheter perioperatively thoracic epidural analgesia using 0,2% bupicavaine with fentanyl intravenous rescue ephedrine administration preventive analgesia will be assured using 0,2% bupicavaine (Bupivacainum Hydrochloricum WZF 0.5%, 5 mg/mL, 10 mL, Polfa Warszawa S.A, Warsaw, Poland) with fentanyl via thoracic epidural catheter perioperatively thoracic epidural analgesia using 0,2% bupicavaine with fentanyl concentrate of red blood cells preventive analgesia will be assured using 0,2% bupicavaine (Bupivacainum Hydrochloricum WZF 0.5%, 5 mg/mL, 10 mL, Polfa Warszawa S.A, Warsaw, Poland) with fentanyl via thoracic epidural catheter perioperatively thoracic epidural analgesia using 0,2% bupicavaine with fentanyl red blood cells autotransfusion preventive analgesia will be assured using 0,2% bupicavaine (Bupivacainum Hydrochloricum WZF 0.5%, 5 mg/mL, 10 mL, Polfa Warszawa S.A, Warsaw, Poland) with fentanyl via thoracic epidural catheter perioperatively thoracic epidural analgesia using 0,2% bupicavaine with fentanyl primary treatment of postoperative nausea and vomiting (PONV) preventive analgesia will be assured using 0,2% bupicavaine (Bupivacainum Hydrochloricum WZF 0.5%, 5 mg/mL, 10 mL, Polfa Warszawa S.A, Warsaw, Poland) with fentanyl via thoracic epidural catheter perioperatively thoracic epidural analgesia using 0,2% bupicavaine with fentanyl secondary treatment of postoperative nausea and vomiting (PONV) preventive analgesia will be assured using 0,2% bupicavaine (Bupivacainum Hydrochloricum WZF 0.5%, 5 mg/mL, 10 mL, Polfa Warszawa S.A, Warsaw, Poland) with fentanyl via thoracic epidural catheter perioperatively thoracic epidural analgesia using 0,2% bupicavaine with fentanyl intraopertative fluid challenge (IFC) preventive analgesia will be assured using 0,2% bupicavaine (Bupivacainum Hydrochloricum WZF 0.5%, 5 mg/mL, 10 mL, Polfa Warszawa S.A, Warsaw, Poland) with fentanyl via thoracic epidural catheter perioperatively thoracic epidural analgesia using 0,2% bupicavaine with fentanyl postoperative rescue opioid analgesia using morphine preventive analgesia will be assured using 0,2% bupicavaine (Bupivacainum Hydrochloricum WZF 0.5%, 5 mg/mL, 10 mL, Polfa Warszawa S.A, Warsaw, Poland) with fentanyl via thoracic epidural catheter perioperatively intravenous analgesia using metamizole with tramadol intravenous rescue opioid analgesia using fentanyl preventive analgesia will be assured using intravenous infusion using metamizole 5 gram / 24 hours ((Pyralgin 0.5g/ml, 2 ml solution; Polpharma, Poland) with tramadol 400 mg/24h (50 mg/ml, 100 mg/2 ml solution; Polpharma, Poland) perioperatively intravenous analgesia using metamizole with tramadol intravenous rescue atropine administration preventive analgesia will be assured using intravenous infusion using metamizole 5 gram / 24 hours ((Pyralgin 0.5g/ml, 2 ml solution; Polpharma, Poland) with tramadol 400 mg/24h (50 mg/ml, 100 mg/2 ml solution; Polpharma, Poland) perioperatively intravenous analgesia using metamizole with tramadol intravenous rescue urapidil administration preventive analgesia will be assured using intravenous infusion using metamizole 5 gram / 24 hours ((Pyralgin 0.5g/ml, 2 ml solution; Polpharma, Poland) with tramadol 400 mg/24h (50 mg/ml, 100 mg/2 ml solution; Polpharma, Poland) perioperatively intravenous analgesia using metamizole with tramadol intravenous rescue ephedrine administration preventive analgesia will be assured using intravenous infusion using metamizole 5 gram / 24 hours ((Pyralgin 0.5g/ml, 2 ml solution; Polpharma, Poland) with tramadol 400 mg/24h (50 mg/ml, 100 mg/2 ml solution; Polpharma, Poland) perioperatively intravenous analgesia using metamizole with tramadol concentrate of red blood cells preventive analgesia will be assured using intravenous infusion using metamizole 5 gram / 24 hours ((Pyralgin 0.5g/ml, 2 ml solution; Polpharma, Poland) with tramadol 400 mg/24h (50 mg/ml, 100 mg/2 ml solution; Polpharma, Poland) perioperatively intravenous analgesia using metamizole with tramadol red blood cells autotransfusion preventive analgesia will be assured using intravenous infusion using metamizole 5 gram / 24 hours ((Pyralgin 0.5g/ml, 2 ml solution; Polpharma, Poland) with tramadol 400 mg/24h (50 mg/ml, 100 mg/2 ml solution; Polpharma, Poland) perioperatively intravenous analgesia using metamizole with tramadol primary treatment of postoperative nausea and vomiting (PONV) preventive analgesia will be assured using intravenous infusion using metamizole 5 gram / 24 hours ((Pyralgin 0.5g/ml, 2 ml solution; Polpharma, Poland) with tramadol 400 mg/24h (50 mg/ml, 100 mg/2 ml solution; Polpharma, Poland) perioperatively intravenous analgesia using metamizole with tramadol secondary treatment of postoperative nausea and vomiting (PONV) preventive analgesia will be assured using intravenous infusion using metamizole 5 gram / 24 hours ((Pyralgin 0.5g/ml, 2 ml solution; Polpharma, Poland) with tramadol 400 mg/24h (50 mg/ml, 100 mg/2 ml solution; Polpharma, Poland) perioperatively intravenous analgesia using metamizole with tramadol intraopertative fluid challenge (IFC) preventive analgesia will be assured using intravenous infusion using metamizole 5 gram / 24 hours ((Pyralgin 0.5g/ml, 2 ml solution; Polpharma, Poland) with tramadol 400 mg/24h (50 mg/ml, 100 mg/2 ml solution; Polpharma, Poland) perioperatively intravenous analgesia using metamizole with tramadol postoperative rescue opioid analgesia using morphine preventive analgesia will be assured using intravenous infusion using metamizole 5 gram / 24 hours ((Pyralgin 0.5g/ml, 2 ml solution; Polpharma, Poland) with tramadol 400 mg/24h (50 mg/ml, 100 mg/2 ml solution; Polpharma, Poland) perioperatively
- Primary Outcome Measures
Name Time Method pain perception intraoperatively from the skin incision till placement of last suture by the operator, an average of 2 hours 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
- Secondary Outcome Measures
Name Time Method pain perception postoperatively from extubation in the operating theatre until discharge to department of vascular surgery, but not shorter than half an hour 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 ).
PONV (postoperative nausea and vomiting) 48 hours 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.
haemodynamic stability from the beginning of induction of anaesthesia till discharge to department of vascular surgery, on average several hours 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)
Trial Locations
- Locations (1)
Medical University of Silesia
🇵🇱Sosnowiec, Silesia, Poland
Medical University of Silesia🇵🇱Sosnowiec, Silesia, Poland