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Aortic AneurysmAoA-AAANCT06609993

AoA Guided Thoracic Epidural Analgesia for Abdominal Aortic Repair

A study testing intravenous rescue opioid analgesia using fentanyl, intravenous rescue atropine administration and intravenous rescue urapidil administration in people with Aortic Aneurysm and Postoperative Nausea and Vomiting, run by Michał Stasiowski at 1 site in Poland.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 to 80 years
What is being tested?
intravenous rescue opioid analgesia using fentanyl, intravenous rescue atropine administration and intravenous rescue urapidil administration
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
75 participants
Where
1 sitePoland
Study dates
12 Dec 2017to 31 Mar 2020
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

Poland1 site

  • Medical University of Silesia

    Sosnowiec, Silesian Voivodeship, 41-200

Other trials in Poland

About this study

Official title: Thoracic Epidural Analgesia Using Bupivacaine or Ropivacaine With Fentanyl in Patients Undergoing Abdominal Aorctic Repair Under Adequacy of Anaestesia Guidance

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.

Read the 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

Being tested
intravenous rescue opioid analgesia using fentanyl, intravenous rescue atropine administration, intravenous rescue urapidil administration, intravenous rescue ephedrine administration, concentrate of red blood cells
Keywords
Surgical Pleth Index (SPI), General Anaesthesia (GA),, Numerical Pain Rating Scale (NPRS), Adequacy of Anaesthesia (AoA), metamizole, tramadol, thoracic epidural analgesia, bupivacaine, ropivacaine
Medical subject headings
Aortic Aneurysm, Postoperative Nausea and Vomiting, Pain, Postoperative

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • intravenous rescue opioid analgesia using fentanylDrug

    Also called IROA-F

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

  • intravenous rescue atropine administrationDrug

    Also called IRAA

    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 administrationDrug

    Also called IRUA

    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 administrationDrug

    Also called IREA

    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 cellsBiological

    Also called RBC

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

  • red blood cells autotransfusionBiological

    Also called cell saver

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

  • primary treatment of postoperative nausea and vomiting (PONV)Drug

    Also called primary treatment of 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)Drug

    Also called treatment of persistent 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)Drug

    Also called IFC

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

  • postoperative rescue opioid analgesia using morphineDrug

    Also called PROA-M

    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)

Study groups in NCT06609993
Study groupRoleWhat they receive
thoracic epidural analgesia using 0,2% ropicavaine with fentanylExperimentalpreventive 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
Receives: 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 fentanylExperimentalpreventive 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
Receives: 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 tramadolExperimentalpreventive 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
Receives: 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

What is being measured

The primary outcome is the main question the study is designed to answer.

  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

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

Secondary outcomes (3)

  1. 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 ).

    Measured: from extubation in the operating theatre until discharge to department of vascular surgery, but not shorter than half an hour

  2. 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.

    Measured: 48 hours

  3. 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)

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted24 Sep 2024
  2. Study start12 Dec 2017
  3. Primary completion31 Mar 2020
  4. Study completion31 Mar 2020

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Crossover
Masking
Single blind
Who is masked
Participant
Enrolment
75 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06609993
Sponsor's protocol ID
SilesianMUKOAiIT11
Acronym
AoA-AAA
Status last verified
Sep 2024
First submitted
23 Aug 2024
Last updated
24 Sep 2024
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 38215709

  • 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.

    PubMed 36140567

  • 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.

    PubMed 36803564

  • 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.

    PubMed 36926752

  • 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.

    PubMed 27543532

  • 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.

    PubMed 30605991

  • 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.

    PubMed 9105981

  • 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.

    PubMed 27575452

Questions about this trial

What is this clinical trial studying?

A study testing intravenous rescue opioid analgesia using fentanyl, intravenous rescue atropine administration and intravenous rescue urapidil administration in people with Aortic Aneurysm and Postoperative Nausea and Vomiting, run by Michał Stasiowski at 1 site in Poland.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 24 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Poland. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

pain perception intraoperatively (time frame: from the skin incision till placement of last suture by the operator, an average of 2 hours). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06609993, which also lists 8 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Sep 2024.

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