AoA Guided Thoracic Epidural Analgesia for Abdominal Aortic Repair

NCT06609993 | Completed DMC

• 1 other identifier: SilesianMUKOAiIT11
• Study Type: interventional
• Target: 75
• Locations: 1 country
• Sites: 1

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.

Conditions

Aortic Aneurysm; Postoperative Nausea and Vomiting; Postoperative Pain; Haemodynamic Stability

Keywords

Surgical Pleth Index (SPI); General Anaesthesia (GA),; Numerical Pain Rating Scale (NPRS); Adequacy of Anaesthesia (AoA); metamizole; tramadol; thoracic epidural analgesia; bupivacaine; ropivacaine

Outcome Measures

Primary Outcomes (1)

• 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

  from the skin incision till placement of last suture by the operator, an average of 2 hours

Secondary Outcomes (3)

• pain perception postoperatively

  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)

  48 hours

• haemodynamic stability

  from the beginning of induction of anaesthesia till discharge to department of vascular surgery, on average several hours

Study Arms (3)

thoracic epidural analgesia using 0,2% ropicavaine with fentanyl

EXPERIMENTAL

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

Drug: intravenous rescue opioid analgesia using fentanyl; Drug: intravenous rescue atropine administration; Drug: intravenous rescue urapidil administration; Drug: intravenous rescue ephedrine administration; Biological: concentrate of red blood cells; Biological: red blood cells autotransfusion; Drug: 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

thoracic epidural analgesia using 0,2% bupicavaine with fentanyl

EXPERIMENTAL

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

Drug: intravenous rescue opioid analgesia using fentanyl; Drug: intravenous rescue atropine administration; Drug: intravenous rescue urapidil administration; Drug: intravenous rescue ephedrine administration; Biological: concentrate of red blood cells; Biological: red blood cells autotransfusion; Drug: 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

intravenous analgesia using metamizole with tramadol

EXPERIMENTAL

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

Drug: intravenous rescue opioid analgesia using fentanyl; Drug: intravenous rescue atropine administration; Drug: intravenous rescue urapidil administration; Drug: intravenous rescue ephedrine administration; Biological: concentrate of red blood cells; Biological: red blood cells autotransfusion; Drug: 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

Interventions

intravenous rescue opioid analgesia using fentanyl DRUG

intraoperative rescue opioid analgesia using 1mcg/kg of fentanyl (Fentanyl WZF, POlfa Warsawa, Poland) )/ body weight when SPI value \> 15 baseline

Also known as: IROA-F

intravenous analgesia using metamizole with tramadol; thoracic epidural analgesia using 0,2% bupicavaine with fentanyl; thoracic epidural analgesia using 0,2% ropicavaine with fentanyl

intravenous rescue atropine administration DRUG

atropine (Atropinum Sulfuricum WZF, POlfa Warsawa, Poland) in a dose of 0,5mg/kg of will be administered intravenously when heart rate \< 50

Also known as: IRAA

intravenous analgesia using metamizole with tramadol; thoracic epidural analgesia using 0,2% bupicavaine with fentanyl; thoracic epidural analgesia using 0,2% ropicavaine with fentanyl

intravenous rescue urapidil administration DRUG

urapidil (Ebrantil 25, Takeda PHARMA, Japan) in a dose of 10 mg will be administered intravenously when DAP \> 110 mmHg or SAP \> 200 mmHg

Also known as: IRUA

intravenous analgesia using metamizole with tramadol; thoracic epidural analgesia using 0,2% bupicavaine with fentanyl; thoracic epidural analgesia using 0,2% ropicavaine with fentanyl

intravenous rescue ephedrine administration DRUG

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

Also known as: IREA

intravenous analgesia using metamizole with tramadol; thoracic epidural analgesia using 0,2% bupicavaine with fentanyl; thoracic epidural analgesia using 0,2% ropicavaine with fentanyl

concentrate of red blood cells BIOLOGICAL

concentrate of red blood cells will be transfused when concentration of haemoglobin \< 10g%

Also known as: RBC

intravenous analgesia using metamizole with tramadol; thoracic epidural analgesia using 0,2% bupicavaine with fentanyl; thoracic epidural analgesia using 0,2% ropicavaine with fentanyl

red blood cells autotransfusion BIOLOGICAL

red blood cells from the operation site will be retransfused using cell saver

Also known as: cell saver

intravenous analgesia using metamizole with tramadol; thoracic epidural analgesia using 0,2% bupicavaine with fentanyl; thoracic epidural analgesia using 0,2% ropicavaine with fentanyl

primary treatment of postoperative nausea and vomiting (PONV) DRUG

dexamethasone ((Dexaven 4mg/ml, Jelfa, Poland) in a dose of 4 mg will be administered intravenously when incidence of PONV is observed

Also known as: primary treatment of PONV

intravenous analgesia using metamizole with tramadol; thoracic epidural analgesia using 0,2% bupicavaine with fentanyl; thoracic epidural analgesia using 0,2% ropicavaine with fentanyl

secondary treatment of postoperative nausea and vomiting (PONV) DRUG

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

Also known as: treatment of persistent PONV

intravenous analgesia using metamizole with tramadol; thoracic epidural analgesia using 0,2% bupicavaine with fentanyl; thoracic epidural analgesia using 0,2% ropicavaine with fentanyl

intraopertative fluid challenge (IFC) DRUG

3 mililitre of synthetic colloid will be transfused intravenously per each sudden blood loss of 1 mililitre

Also known as: IFC

intravenous analgesia using metamizole with tramadol; thoracic epidural analgesia using 0,2% bupicavaine with fentanyl; thoracic epidural analgesia using 0,2% ropicavaine with fentanyl

postoperative rescue opioid analgesia using morphine DRUG

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)

Also known as: PROA-M

intravenous analgesia using metamizole with tramadol; thoracic epidural analgesia using 0,2% bupicavaine with fentanyl; thoracic epidural analgesia using 0,2% ropicavaine with fentanyl

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• antiplatelet therapy
• allergy to local anaesthetics, metamizole or tramadol
• necessity of administration of vasoactive drugs influencing SPI monitoring

Sponsors & Collaborators

• Michał Stasiowski: lead
• Silesian University of Medicine: collaborator

Study Sites (1)

Medical University of Silesia

Sosnowiec, Silesian Voivodeship, 41-200, Poland

Location

Related Publications (8)

• 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.

  PMID: 38215709 BACKGROUND

• 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.

  PMID: 36140567 BACKGROUND

• 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.

  PMID: 36803564 BACKGROUND

• 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.

  PMID: 36926752 BACKGROUND

• 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.

  PMID: 27543532 BACKGROUND

• 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.

  PMID: 30605991 BACKGROUND

• 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.

  PMID: 9105981 BACKGROUND

• 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.

  PMID: 27575452 BACKGROUND

MeSH Terms

Conditions

Aortic Aneurysm; Postoperative Nausea and Vomiting; Pain, Postoperative

Interventions

Operative Blood Salvage

Condition Hierarchy (Ancestors)

Aneurysm; Vascular Diseases; Cardiovascular Diseases; Aortic Diseases; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Nausea; Signs and Symptoms, Digestive; Signs and Symptoms; Vomiting; Pain; Neurologic Manifestations

Intervention Hierarchy (Ancestors)

Tissue and Organ Harvesting; Transplantation; Surgical Procedures, Operative

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator, Department of Anaesthesiology and Intensive Therapy

Study Record Dates

• First Submitted: August 23, 2024
• First Posted: September 24, 2024
• Study Start: December 12, 2017
• Primary Completion: March 31, 2020
• Study Completion: March 31, 2020
• Last Updated: September 24, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share

Locations

PL (1)