Opioid Free Anesthesia in Thoracic Surgery

Ketamine

Brief Summary

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.

Intervention / Treatment

  • 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: 1. 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; 2. 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.

Condition or Disease

  • Thoracic Surgery
  • Analgesics, Opioid
  • Anesthesia, Conduction

Phase

  • Not Applicable

    • Study Design

    Study type: INTERVENTIONAL
    Status: Completed
    Study results: No Results Available
    Age: 18 Years to 65 Years
    Enrollment: 66 (ACTUAL)
    Funded by: Other
    Allocation: Randomized
    Primary Purpose: Treatment

    Masking

    SINGLE:
    • Participant

    Clinical Trial Dates

    Start date: Dec 01, 2015 ACTUAL
    Primary Completion: Mar 01, 2018 ACTUAL
    Completion Date: Mar 01, 2018 ACTUAL
    Study First Posted: Apr 21, 2020 ACTUAL
    Results First Posted: Aug 31, 2020
    Last Updated: Oct 29, 2022

    Sponsors / Collaborators

    Lead Sponsor: Medical University of Silesia
    Responsible Party: N/A

    Location

    Silesia, Poland
    Zabrze, Silesia, Poland

    Participant Groups

    • General anesthesia was induced with midazolam 0.1 mg∙kg-1, propofol 2 mg∙kg-1, and cisatracurium 0.15 mg∙kg-1. The patients were intubated with a left-sided double-lumen tube in adequate size and positioned laterally. Anesthesia was maintained with 1 minimum alveolar concentration (MAC) sevoflurane. The patients awoke from anesthesia in a post-anesthesia care unit, and were extubated after the administration of adequate doses of atropine and neostigmine as required. After surgery, if a patient complained of pain then she/he was given i.v. oxycodone by an anesthetist before commencing the patient controlled analgesia (PCA). This dose was titrated to achieve adequate analgesia. Each patient then commenced PCA. The PCA solution was oxycodone (1mgml-1) and the PCA was programmed to allow a self-administered bolus dose of 1mg oxycodone with a lockout time of 5 min. Additionally, patients were given 1 g intravenous paracetamol every 6 h and 100mg of intravenous ketoprofen every 12 h.

    • General anesthesia was induced with midazolam 0.1 mg∙kg-1, propofol 2 mg∙kg-1, and cisatracurium 0.15 mg∙kg-1. The patients were intubated with a left-sided double-lumen tube in adequate size and positioned laterally. Anesthesia was maintained with 1 minimum alveolar concentration (MAC) sevoflurane. The patients awoke from anesthesia in a post-anesthesia care unit, and were extubated after the administration of adequate doses of atropine and neostigmine as required. After surgery, if a patient complained of pain then she/he was given i.v. oxycodone by an anesthetist before commencing the patient controlled analgesia (PCA). This dose was titrated to achieve adequate analgesia. Each patient then commenced PCA. The PCA solution was oxycodone (1mgml-1) and the PCA was programmed to allow a self-administered bolus dose of 1mg oxycodone with a lockout time of 5 min. Additionally, patients were given 1 g intravenous paracetamol every 6 h and 100mg of intravenous ketoprofen every 12 h.

    Eligibility Criteria

    Sex: All
    Minimum Age: 18
    Maximum Age: 65
    Age Groups: Adult / Older Adult
    Healthy Volunteers: Yes

    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)

    Primary Outcomes

    • 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.

    • Intraoperative usage of opioids was noted.

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

    • Heart rate was recorded every 5 minutes during operation.

    Secondary Outcomes

    • Overall analgesia satisfaction was recorded at 24 and 48 postoperative hours with Likert scale. The points in Likert scale were assigned as below: 1. Very satisfied. 2. Satisfied. 3. Neither satisfied nor dissatisfied. 4. Dissatisfied. 5. Very dissatisfied.

    • 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.

    • 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: 0. No pain during coughing. 1. Pain during coughing. 2. Pain during breathing. 3. Constant light pain. 4. Constant strong pain.

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

    • Heart rate was recorded at 0, 1, 2, 4, 8, 12, 18, 24, 30, 36, 42, 48 postoperative 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: 1. Patient is anxious and agitated or restless, or both. 2. Patient is co-operative, oriented, and tranquil. 3. Patient responds to commands only. 4. Patient exhibits brisk response to light glabellar tap or loud auditory stimulus. 5. Patient exhibits a sluggish response to light glabellar tap or loud auditory stimulus. 6. Patient exhibits no response.

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

    More Details

    NCT Number: NCT04355468
    Other IDs: OPA-1
    Study URL: https://clinicaltrials.gov/study/NCT04355468
    Last updated: Sep 29, 2023