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OpenTrials
Completed

NCT Number: NCT06683911

Opioids Continue to Play a Primary Role in the Management of Perioperative Pain Due to Opioid-Free Anesthesia in Open Heart Surgery.

Due to their superior efficacy in analgesia, opioids continue to play a primary role in the control of intraoperative and postoperative pain. Fentanyl, remifentanil, morphine, and tramadol are commonly used opioids during the perioperative period in cardiac surgery. However, the use of opioids requires monitoring, caution, and expertise due to their adverse effects, such as myocardial depression, prolonged respiratory depression, constipation, nausea and vomiting, itching, and dependence. To avoid the side effects caused by opioids, new opioid-free anesthesia protocols have been developed. In addition to avoiding unwanted opioid-related side effects, opioid-free anesthesia provides other benefits, such as rapid postoperative recovery, improvement in postoperative pain scores, enhancement in inflammation parameters, and reduction in postoperative delirium. In opioid-free anesthesia protocols, medications such as dexmedetomidine, magnesium sulfate, lidocaine, ketamine, gabapentin (preoperative and postoperative), dexamethasone, acetaminophen, esmolol, and urapidil are used alongside regional anesthesia techniques to control pain and sympathetic activity.

In this study, patients undergoing elective cardiopulmonary bypass surgery will be included. Procedures will be conducted according to our clinic's routine protocol with monitored general anesthesia induction. Patients included in the study will receive regional blocks and local infiltration anesthesia, which are routine in our clinic. The anesthesia teams, working with the same surgical team in our clinic, will administer either opioid-free anesthesia or anesthesia with opioids. During the perioperative period, the clinicians involved in the study will only observe the patients and record data without intervening in the anesthesia practices.

In this study, our primary aim is to compare the effects of opioid anesthesia and opioid-free anesthesia on postoperative recovery in patients who are provided with multimodal analgesic control through fascial plane blocks and continuous local infiltration anesthesia during the perioperative period. Our secondary objectives are to investigate the effects of opioid-free anesthesia on intensive care and hospital stays, postoperative delirium, inflammation parameters, postoperative surgical complications, arrhythmia, total drug doses used, cost, and patient satisfaction.

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Key information

Conditions

Undergoing Open-Heart Surgery

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Ankara Bilkent City Hospital

Ankara, Cankaya, 06800, Turkey (Türkiye)

About this study

Due to their superior efficacy in analgesia, opioids continue to play a primary role in the control of intraoperative and postoperative pain. Fentanyl, remifentanil, morphine, and tramadol are commonly used opioids during the perioperative period in cardiac surgery. However, the use of opioids requires monitoring, caution, and expertise due to their adverse effects, such as myocardial depression, prolonged respiratory depression, constipation, nausea and vomiting, itching, and dependence. To avoid the side effects caused by opioids, new opioid-free anesthesia protocols have been developed. In addition to avoiding unwanted opioid-related side effects, opioid-free anesthesia provides other benefits, such as rapid postoperative recovery, improvement in postoperative pain scores, enhancement in inflammation parameters, and reduction in postoperative delirium. In opioid-free anesthesia protocols, medications such as dexmedetomidine, magnesium sulfate, lidocaine, ketamine, gabapentin (preoperative and postoperative), dexamethasone, acetaminophen, esmolol, and urapidil are used alongside regional anesthesia techniques to control pain and sympathetic activity.

In this study, patients undergoing elective cardiopulmonary bypass surgery will be included. Procedures will be conducted according to our clinic's routine protocol with monitored general anesthesia induction. Patients included in the study will receive regional blocks and local infiltration anesthesia, which are routine in our clinic. The anesthesia teams, working with the same surgical team in our clinic, will administer either opioid-free anesthesia or anesthesia with opioids. During the perioperative period, the clinicians involved in the study will only observe the patients and record data without intervening in the anesthesia practices.

In this study, our primary aim is to compare the effects of opioid anesthesia and opioid-free anesthesia on postoperative recovery in patients who are provided with multimodal analgesic control through fascial plane blocks and continuous local infiltration anesthesia during the perioperative period. Our secondary objectives are to investigate the effects of opioid-free anesthesia on intensive care and hospital stays, postoperative delirium, inflammation parameters, postoperative surgical complications, arrhythmia, total drug doses used, cost, and patient satisfaction.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Aged 18 to 80
  • ASA 1, 2, or 3 status
  • Will undergo open-heart surgery with cardiopulmonary bypass

Exclusion criteria

  • Under 18 years of age
  • Over 80 years of age
  • Patients with signs of severe organ failure (e.g., kidney or liver failure)
  • ASA classification of 4 or higher
  • BMI > 40
  • Left ventricular ejection fraction < 25%
  • Patients with severe arrhythmia
  • Patients with severe valve disease
  • Aortic surgery
  • Preoperative intubation
  • Preoperative life support dependency
  • Limited preoperative cooperation
  • Failed block attempts
  • Allergy to any drugs used in the study
  • Patients with severe neurological dysfunction
  • Patients with contraindications for blocks

Patients who were intubated for more than 12 hours were excluded from the study. Patients who required IABP or ECMO during the perioperative period were excluded from the study. Patients with postoperative cerebrovascular disease and those requiring sedation in the postoperative period were also excluded from the study.

Treatment and study plan

non Opioids

Drug

It is planned to avoid opioid side effects by applying opioid-free anesthesia during the perioperative period.

Other names: opioid anaesthesia

Opioid

Drug

Routine general anesthesia in cardiac surgery

Primary outcomes

  1. extubation time

    Time frame: postoperative 7 days

    During routine patient visits, the patient's extubation time will be recorded.

  2. mobilization

    Time frame: postoperative 7 days

    During routine patient visits, the patient's first mobilization time will be recorded.

  3. first bowel movement

    Time frame: postoperative 7 days

    During routine patient visits, the patient's first bowel movement in the postoperative period will be recorded and documented.

  4. vomiting

    Time frame: postoperative 1 days

    The patient is questioned and recorded to determine the frequency of opioid side effects during hospital visits.The patient will be visited at postoperative hours 0, 3, 6, 12, and 24, and vomiting will be assessed. If the patient has vomited, the number of times they have vomited will be asked and recorded. The total number of times the patient has vomited within 24 hours will be documented.

  5. nausea

    Time frame: postoperative 1 days

    The patient is questioned and recorded to determine the frequency of opioid side effects during hospital visits. The patient will be visited at postoperative hours 0, 3, 6, 12, and 24, and their nausea will be assessed. The patient will be asked to provide a number from 0 to 10 to rate the severity of their nausea, and the response will be recorded. 0 means no nausea, and 10 means severe nausea.

  6. Itching

    Time frame: postoperative 1 days

    The patient is questioned and recorded to determine the frequency of opioid side effects during hospital visits. The patient will be visited at postoperative hours 0, 3, 6, 12, and 24, and itching will be assessed.

  7. visual analog scale

    Time frame: postoperative 7 days

    The patient will be visited at postoperative hours 0, 3, 6, 12, and 24, and their pain will be assessed. The patient will be asked to provide a number from 0 to 10 to rate the intensity of their pain, and the response will be recorded. 0 means no pain, and 10 means unbearable severe pain.

  8. opening eyes first time

    Time frame: postoperative 1 days

    The time when the patient first opens their eyes during the ward round is noted and recorded.

  9. Shivering

    Time frame: postoperative 1 days

    The patient is questioned and recorded to determine the frequency of opioid side effects during hospital visits. The patient will be visited at postoperative hours 0, 3, 6, 12, and 24, and shivering will be assessed.

  10. additional analgesics

    Time frame: postoperative 1 days

    It will be assessed whether there is a need for additional analgesics within the first 24 hours. If additional analgesics are required, it will be recorded whether NSAIDs (Non-Steroidal Anti-Inflammatory Drugs) were administered. If they were, the number of times the required and dosage of drug they were given will be noted. It will be recorded whether tramadol was administered. If it was, the number of times it was given and the required dosage in milligrams (mg) will be noted.

  11. The Behavioral Pain Scale (BPS)

    Time frame: postoperative 1 days

    Intubated patients will be assessed at 0,3,6,12,24 hours; using the following criteria, and the total score will be recorded

    Facial expression Relaxed=1 Partially tightened (e.g., brow lowering)=2 Fully tightened (e.g., eyelid closing)=3 Grimacing=4

    Upper limb movements No movement=1 Partially bent=2 Fully bent with finger flexion=3 Permanently retracted=4

    Compliance with mechanical ventilation Tolerating movement=1 Coughing but tolerating ventilation for most of the time=2 Fighting ventilator=3 Unable to control ventilation=4

Secondary outcomes

  1. glascow coma scale

    Time frame: postoperative 7 days

    0,3,6,12 and 24.hour glascow coma scale will be recorded.

    • Eye Opening (E):
    • 4: Spontaneous
    • 3: To speech
    • 2: To pain
    • 1: No response
    • Verbal Response (V):
    • 5: Oriented
    • 4: Confused conversation
    • 3: Inappropriate words
    • 2: Incomprehensible sounds
    • 1: No response
    • Motor Response (M):
    • 6: Obeys commands
    • 5: Localizes pain
    • 4: Withdrawal
    • 3: Flexion to pain (decorticate posture)
    • 2: Extension to pain (decerebrate posture)
    • 1: No response

    Total Score:

    • The scores from each of the three categories are added together.

  2. critical care length of stay

    Time frame: postoperative 7 days

    critical care length of stay will be recorded.

  3. hospital length of stay

    Time frame: postoperative 7 days

    The hospital length of stay will be recorded.

  4. QOR-15

    Time frame: postoperative 7 days

    The QOR-15 index was used to assess patient satisfaction. A questionnaire containing 15 questions related to patient recovery is administered to patients 24 hours after extubation. For each question, patients are asked to rate their answers on a scale from 0 to 10. The total score is recorded.

    0 = Never 10 = Always

Sponsors and collaborators

Lead sponsor

Ankara City Hospital Bilkent

Other

Registry information

Official study title

Comparison of the Postoperative Effects of Opioid-Free Anesthesia and Opioid-Based Anesthesia in Patients Undergoing Open-Heart Surgery With Cardiopulmonary Bypass

Acronym: Opioid-Free

Important dates

Study start
2024
Primary completion
2024
Study completion
2025
First posted
Nov 12, 2024
Registry last updated
May 6, 2025

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.