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

Michał Stasiowski

Status

Completed

Conditions

Postoperative Pain

Haemodynamic Stability

Postoperative Nausea and Vomiting

Aortic Aneurysm

Treatments

Drug: intraopertative fluid challenge (IFC)

Biological: red blood cells autotransfusion

Drug: intravenous rescue ephedrine administration

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

Drug: intravenous rescue opioid analgesia using fentanyl

Biological: concentrate of red blood cells

Drug: postoperative rescue opioid analgesia using morphine

Drug: intravenous rescue urapidil administration

Drug: intravenous rescue atropine administration

Drug: secondary treatment of postoperative nausea and vomiting (PONV)

Study type

Interventional

Funder types

Other

Identifiers

NCT06609993

SilesianMUKOAiIT11

Details and patient eligibility

About

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.

Full 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

Enrollment

75 patients

Sex

All

Ages

18 to 80 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Crossover Assignment

Masking

Single Blind

75 participants in 3 patient groups

thoracic epidural analgesia using 0,2% ropicavaine with fentanyl

Experimental group

Description:

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

Treatment:

Drug: secondary treatment of postoperative nausea and vomiting (PONV)

Drug: intravenous rescue atropine administration

Drug: postoperative rescue opioid analgesia using morphine

Drug: intravenous rescue urapidil administration

Biological: concentrate of red blood cells

Drug: intravenous rescue opioid analgesia using fentanyl

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

Drug: intraopertative fluid challenge (IFC)

Biological: red blood cells autotransfusion

Drug: intravenous rescue ephedrine administration

thoracic epidural analgesia using 0,2% bupicavaine with fentanyl

Experimental group

Description:

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

Treatment:

Drug: secondary treatment of postoperative nausea and vomiting (PONV)

Drug: intravenous rescue atropine administration

Drug: postoperative rescue opioid analgesia using morphine

Drug: intravenous rescue urapidil administration

Biological: concentrate of red blood cells

Drug: intravenous rescue opioid analgesia using fentanyl

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

Drug: intraopertative fluid challenge (IFC)

Biological: red blood cells autotransfusion

Drug: intravenous rescue ephedrine administration

intravenous analgesia using metamizole with tramadol

Experimental group

Description:

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

Treatment:

Drug: secondary treatment of postoperative nausea and vomiting (PONV)

Drug: intravenous rescue atropine administration

Drug: postoperative rescue opioid analgesia using morphine

Drug: intravenous rescue urapidil administration

Biological: concentrate of red blood cells

Drug: intravenous rescue opioid analgesia using fentanyl

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

Drug: intraopertative fluid challenge (IFC)

Biological: red blood cells autotransfusion

Drug: intravenous rescue ephedrine administration