AoA Guided Thoracic Epidural Analgesia for Abdominal Aortic Repair (AoA-AAA)

September 19, 2024 updated by: Michał Stasiowski

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Study Type

Interventional

Enrollment (Actual)

75

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Poland
    • Silesia
      • Sosnowiec, Silesia, Poland, 41-200
        • Medical University of Silesia

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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
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
Other Names:
  • IROA-F
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
Other Names:
  • IRAA
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
Other Names:
  • IRUA
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
Other Names:
  • IREA
Biological: concentrate of red blood cells
concentrate of red blood cells will be transfused when concentration of haemoglobin < 10g%
Other Names:
  • RBC
Biological: red blood cells autotransfusion
red blood cells from the operation site will be retransfused using cell saver
Other Names:
  • 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
Other Names:
  • primary treatment of PONV
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
Other Names:
  • treatment of persistent PONV
Drug: intraopertative fluid challenge (IFC)
3 mililitre of synthetic colloid will be transfused intravenously per each sudden blood loss of 1 mililitre
Other Names:
  • IFC
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)
Other Names:
  • PROA-M
Experimental: 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
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
Other Names:
  • IROA-F
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
Other Names:
  • IRAA
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
Other Names:
  • IRUA
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
Other Names:
  • IREA
Biological: concentrate of red blood cells
concentrate of red blood cells will be transfused when concentration of haemoglobin < 10g%
Other Names:
  • RBC
Biological: red blood cells autotransfusion
red blood cells from the operation site will be retransfused using cell saver
Other Names:
  • 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
Other Names:
  • primary treatment of PONV
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
Other Names:
  • treatment of persistent PONV
Drug: intraopertative fluid challenge (IFC)
3 mililitre of synthetic colloid will be transfused intravenously per each sudden blood loss of 1 mililitre
Other Names:
  • IFC
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)
Other Names:
  • PROA-M
Experimental: 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
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
Other Names:
  • IROA-F
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
Other Names:
  • IRAA
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
Other Names:
  • IRUA
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
Other Names:
  • IREA
Biological: concentrate of red blood cells
concentrate of red blood cells will be transfused when concentration of haemoglobin < 10g%
Other Names:
  • RBC
Biological: red blood cells autotransfusion
red blood cells from the operation site will be retransfused using cell saver
Other Names:
  • 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
Other Names:
  • primary treatment of PONV
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
Other Names:
  • treatment of persistent PONV
Drug: intraopertative fluid challenge (IFC)
3 mililitre of synthetic colloid will be transfused intravenously per each sudden blood loss of 1 mililitre
Other Names:
  • IFC
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)
Other Names:
  • PROA-M

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
pain perception intraoperatively
Time Frame: 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
from the skin incision till placement of last suture by the operator, an average of 2 hours

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
pain perception postoperatively
Time Frame: 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 ).
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)
Time Frame: 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.
48 hours
haemodynamic stability
Time Frame: 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)
from the beginning of induction of anaesthesia till discharge to department of vascular surgery, on average several hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Michał Stasiowski

Collaborators

Silesian University of Medicine

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 12, 2017

Primary Completion (Actual)

March 31, 2020

Study Completion (Actual)

March 31, 2020

Study Registration Dates

First Submitted

August 23, 2024

First Submitted That Met QC Criteria

September 19, 2024

First Posted (Actual)

September 24, 2024

Study Record Updates

Last Update Posted (Actual)

September 24, 2024

Last Update Submitted That Met QC Criteria

September 19, 2024

Last Verified

September 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SilesianMUKOAiIT11

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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