AoA Guided Thoracic Epidural Analgesia for Abdominal Aortic Repair

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

Interventions

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

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

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

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

BIOLOGICAL

concentrate of red blood cells

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

BIOLOGICAL

red blood cells autotransfusion

red blood cells from the operation site will be retransfused using 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

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

DRUG

intraopertative fluid challenge (IFC)

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

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)

Sponsors & Collaborators

• Silesian University of Medicine

  collaborator OTHER

• Michał Stasiowski

  lead OTHER

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Model

CROSSOVER

Eligibility

Min Age

18 Years

Max Age

80 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2017-12-12

Primary Completion

2020-03-31

Completion

2020-03-31

Countries

• Poland

Study Locations