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Completed

NCT Number: NCT04355468

Opioid Free Anesthesia in Thoracic Surgery

Proper assessment of pain and adequate analgesia in thoracic surgery is a challenging issue for medical practitioners. Basic aspects of thoracic anaesthesia are general anesthesia, intubation with double lumen tube and separation of lung ventilation, however proper analgesia needs to be standardized. Role of opioids in this clinical setting is reduced due to high risk of respiratory system complications. Instead, use of opioid free anaesthesia and regional anaesthesia is proposed. The aim of this study is to compare the use of opioid anaesthesia with opioid free anaesthesia and paravertebral block.

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Key information

Conditions

Thoracic Surgery Analgesics, Opioid Anesthesia, Conduction

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Samodzielny Publiczny Szpital Kliniczny nr 1

Zabrze, Silesian Voivodeship, 41-800, Poland

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • body mass index between 19-30 kg/m2,
  • American Society of Anesthesiology (ASA) physical status between 1 and 3

Exclusion criteria

  • lack of consent
  • significant coagulopathy,
  • contraindication to drugs used in protocol
  • history of chronic pain,
  • chest wall neoplastic invasion,
  • previous thoracic spine surgery,
  • mental state preventing from effective use of PCA device,
  • renal failure (GFR <60 ml/min/1,73 m2)

Treatment and study plan

Opioid Anesthesia

Drug

Intraoperatively, fentanyl in fractional doses of 1-3 µg∙kg-1 were applied if the heart rate (HR; Heart Rate) or mean blood pressure (MBP; Mean Blood Pressure) increased by more than 20% above the baseline value obtained just before surgery commencement.

Opioid Free Anaesthesia

Drug

Before the induction of general anesthesia, a single-shot thoracic paravertebral block (ThPVB) was performed at the Th3-Th4 level. An insulated needle was used, connected to a peripheral nerve stimulator. 0.5% bupivacaine (0.3 ml∙kg-1) was then injected after a negative aspiration test. The efficacy of the blockade was checked after 20 min on both sides of the thorax with a plastic ampoule of saline. A difference in the sensation of cold between the sides of the thorax was assumed to indicate an effective block. Afterwards a continuous intravenous infusion of lidocaine and ketamine was started:

  • immediately after anesthesia induction, lidocaine was administered as an i.v. bolus at a dose of 1.5 mg∙kg-1 and ketamine in an i.v. bolus of 0.35 mg∙kg-1;
  • followed by an infusion of lidocaine 2.0 mg∙kg-1∙h-1 for 2 hours, continued at a dose of 1.2 mg∙kg-1∙h-1, and ketamine infusion 0.2 mg∙kg-1∙h-1 for 2 hours, continued at a dose of 0.12 mg∙kg-1∙h-1.

Primary outcomes

  1. Intraoperative pain related stress [oscillations per second]

    Time frame: Period before induction of anaesthesia to termination of anaesthesia

    During general anesthesia the pain-related stress was assessed using a method of skin conductance fluctuations. The measurement was based on changes in skin conductance that arise under the influence of a pain stimulus.

  2. Intraoperative opioid usage [mg]

    Time frame: Intraoperative period

    Intraoperative usage of opioids was noted.

  3. Intraoperative arterial blood pressure [mmHg]

    Time frame: Intraoperative period

    Non-invasive arterial blood pressure was recorded every 5 minutes during operation.

  4. Intraoperative heart rate [bpm]

    Time frame: Intraoperative period

    Heart rate was recorded every 5 minutes during operation.

Secondary outcomes

  1. Overall postoperative analgesia satisfaction

    Time frame: 48 hours

    Overall analgesia satisfaction was recorded at 24 and 48 postoperative hours with Likert scale. The points in Likert scale were assigned as below:

    • Very satisfied.
    • Satisfied.
    • Neither satisfied nor dissatisfied.
    • Dissatisfied.
    • Very dissatisfied.

  2. Postoperative pain intensity (VAS)

    Time frame: 48 hours

    Pain intensity at rest was recorded with Visual Analogue Scale (VAS) at 0, 1, 2, 4, 8, 12, 18, 24, 30, 36, 42, 48 postoperative hours. Patient pointed intensity of symptoms on a 10cm ruler, where 0cm corresponded to no pain and 10cm corresponded to the strongest possible pain.

  3. Postoperative pain intensity (PHHPS)

    Time frame: 48 hours

    Pain intensity at rest was recorded with Prince Henry Hospital Pain Score (PHHPS) at 0, 1, 2, 4, 8, 12, 18, 24, 30, 36, 42, 48 postoperative hours. The points in PHHPS score were assigned as below:

    • No pain during coughing.
    • Pain during coughing.
    • Pain during breathing.
    • Constant light pain.
    • Constant strong pain.

  4. Postoperative arterial blood pressure [mmHg]

    Time frame: 48 hours

    Non-invasive arterial blood pressure was recorded at 0, 1, 2, 4, 8, 12, 18, 24, 30, 36, 42, 48 postoperative hours.

  5. Postoperative heart rate [bmp]

    Time frame: 48 hours

    Heart rate was recorded at 0, 1, 2, 4, 8, 12, 18, 24, 30, 36, 42, 48 postoperative hours.

  6. Postoperative sedation level

    Time frame: 48 hours

    Sedation level was was recorded at 0, 1, 2, 4, 8, 12, 18, 24, 30, 36, 42, 48 postoperative hours with Ramsay scale. The points in Ramsay scale were assigned as below:

    • Patient is anxious and agitated or restless, or both.
    • Patient is co-operative, oriented, and tranquil.
    • Patient responds to commands only.
    • Patient exhibits brisk response to light glabellar tap or loud auditory stimulus.
    • Patient exhibits a sluggish response to light glabellar tap or loud auditory stimulus.
    • Patient exhibits no response.

  7. Postoperative analgesic requirement [mg]

    Time frame: 48 hours

    Analgesic requirement was recorded at 0, 1, 2, 4, 8, 12, 18, 24, 30, 36, 42, 48 postoperative hours.

Sponsors and collaborators

Lead sponsor

Medical University of Silesia

Other

Registry information

Official study title

Opioid-free Anaesthesia Effectiveness in Thoracic Surgery - Objective Measurement With a Skin Conductance Algesimeter: a Randomized Controlled Trial

Important dates

Study start
2015
Primary completion
2018
Study completion
2018
First posted
Apr 21, 2020
Registry last updated
Nov 2, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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