AoA Guided Thoracic Epidural Analgesia for Abdominal Aortic Repair
NCT ID: NCT06609993
Last Updated: 2024-09-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
75 participants
INTERVENTIONAL
2017-12-12
2020-03-31
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
SINGLE
Study Groups
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thoracic epidural analgesia using 0,2% ropicavaine with 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
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
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
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
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
concentrate of red blood cells
concentrate of red blood cells will be transfused when concentration of haemoglobin \< 10g%
red blood cells autotransfusion
red blood cells from the operation site will be retransfused using cell saver
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
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
intraopertative fluid challenge (IFC)
3 mililitre of synthetic colloid will be transfused intravenously per each sudden blood loss of 1 mililitre
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)
thoracic epidural analgesia using 0,2% bupicavaine with 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
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
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
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
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
concentrate of red blood cells
concentrate of red blood cells will be transfused when concentration of haemoglobin \< 10g%
red blood cells autotransfusion
red blood cells from the operation site will be retransfused using cell saver
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
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
intraopertative fluid challenge (IFC)
3 mililitre of synthetic colloid will be transfused intravenously per each sudden blood loss of 1 mililitre
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)
intravenous analgesia using metamizole with tramadol
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 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
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
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
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
concentrate of red blood cells
concentrate of red blood cells will be transfused when concentration of haemoglobin \< 10g%
red blood cells autotransfusion
red blood cells from the operation site will be retransfused using cell saver
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
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
intraopertative fluid challenge (IFC)
3 mililitre of synthetic colloid will be transfused intravenously per each sudden blood loss of 1 mililitre
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)
Interventions
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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
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
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
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
concentrate of red blood cells
concentrate of red blood cells will be transfused when concentration of haemoglobin \< 10g%
red blood cells autotransfusion
red blood cells from the operation site will be retransfused using cell saver
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
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
intraopertative fluid challenge (IFC)
3 mililitre of synthetic colloid will be transfused intravenously per each sudden blood loss of 1 mililitre
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)
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* written consent to undergo general anaesthesia combined with different techniques of pre-emptive intravenous or thoracic epidural analgesia for aortic aneurysm repair
Exclusion Criteria
* allergy to local anaesthetics, metamizole or tramadol
* necessity of administration of vasoactive drugs influencing SPI monitoring
18 Years
80 Years
ALL
No
Sponsors
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Silesian University of Medicine
OTHER
Michał Stasiowski
OTHER
Responsible Party
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Michał Stasiowski
Principal Investigator, Department of Anaesthesiology and Intensive Therapy
Locations
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Medical University of Silesia
Sosnowiec, Silesian Voivodeship, Poland
Countries
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References
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Laferriere-Langlois P, Morisson L, Jeffries S, Duclos C, Espitalier F, Richebe P. Depth of Anesthesia and Nociception Monitoring: Current State and Vision For 2050. Anesth Analg. 2024 Feb 1;138(2):295-307. doi: 10.1213/ANE.0000000000006860. Epub 2024 Jan 12.
Hung KC, Huang YT, Kuo JR, Hsu CW, Yew M, Chen JY, Lin MC, Chen IW, Sun CK. Elevated Surgical Pleth Index at the End of Surgery Is Associated with Postoperative Moderate-to-Severe Pain: A Systematic Review and Meta-Analysis. Diagnostics (Basel). 2022 Sep 6;12(9):2167. doi: 10.3390/diagnostics12092167.
Won YJ, Oh SK, Lim BG, Kim YS, Lee DY, Lee JH. Effect of surgical pleth index-guided remifentanil administration on perioperative outcomes in elderly patients: a prospective randomized controlled trial. BMC Anesthesiol. 2023 Feb 17;23(1):57. doi: 10.1186/s12871-023-02011-5.
Oh SK, Won YJ, Lim BG. Surgical pleth index monitoring in perioperative pain management: usefulness and limitations. Korean J Anesthesiol. 2024 Feb;77(1):31-45. doi: 10.4097/kja.23158. Epub 2023 Mar 17.
Ledowski T, Burke J, Hruby J. Surgical pleth index: prediction of postoperative pain and influence of arousal. Br J Anaesth. 2016 Sep;117(3):371-4. doi: 10.1093/bja/aew226.
Jain N, Gera A, Sharma B, Sood J, Chugh P. Comparison of Surgical Pleth Index-guided analgesia using fentanyl versus conventional analgesia technique in laparoscopic cholecystectomy. Minerva Anestesiol. 2019 Apr;85(4):358-365. doi: 10.23736/S0375-9393.18.12954-3. Epub 2019 Jan 2.
Gold MS, Rockman CB, Riles TS. Comparison of lumbar and thoracic epidural narcotics for postoperative analgesia in patients undergoing abdominal aortic aneurysm repair. J Cardiothorac Vasc Anesth. 1997 Apr;11(2):137-40. doi: 10.1016/s1053-0770(97)90202-0.
Ball L, Pellerano G, Corsi L, Giudici N, Pellegrino A, Cannata D, Santori G, Palombo D, Pelosi P, Gratarola A. Continuous epidural versus wound infusion plus single morphine bolus as postoperative analgesia in open abdominal aortic aneurysm repair: a randomized non-inferiority trial. Minerva Anestesiol. 2016 Dec;82(12):1296-1305. Epub 2016 Aug 30.
Other Identifiers
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SilesianMUKOAiIT11
Identifier Type: -
Identifier Source: org_study_id
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