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

NCT06683911 | Completed

• 1 other identifier: Opioid-Free Anesthesia
• Study Type: observational
• Target: 98
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Undergoing Open-Heart Surgery

Keywords

Open-Heart Surgery, opioid free anesthesia

Outcome Measures

Primary Outcomes (11)

• extubation time

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

  postoperative 7 days

• mobilization

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

  postoperative 7 days

• first bowel movement

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

  postoperative 7 days

• vomiting

  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.

  postoperative 1 days

• nausea

  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.

  postoperative 1 days

• Itching

  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.

  postoperative 1 days

• visual analog scale

  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.

  postoperative 7 days

• opening eyes first time

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

  postoperative 1 days

• Shivering

  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.

  postoperative 1 days

• additional analgesics

  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.

  postoperative 1 days

• The Behavioral Pain Scale (BPS)

  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

  postoperative 1 days

Secondary Outcomes (4)

• glascow coma scale

  postoperative 7 days

• critical care length of stay

  postoperative 7 days

• hospital length of stay

  postoperative 7 days

• QOR-15

  postoperative 7 days

Study Arms (2)

opioid free anaesthesia

İnduction = 1 mg/kg lidocaine, 2-3 mg/kg propofol, 15 mg/kg magnesium, 1 mcg/kg dexmedetomidine (over 10 minutes), and a 0.6 mg/kg rocuronium.1 g acetaminophen, 4 mg ondansetron. Blocks will include bilateral transverse thoracic muscle plane block and/or bilateral serratus anterior plane block with 0.5% bupivacaine (max 2 mg/kg) under ultrasound guidance. Intravenous dexmedetomidine (0.1-1.4 mcg/kg/hr), lidocaine (0.5-1 mg/kg/hr), magnesium (1-10 mg/kg/hr), and propofol (1.5-12 mg/kg/hr) infusions will be adjusted based on hemodynamic parameters to achieve a target BIS value of 40-60. if: heart rate \<80 and blood pressure \>140/90 mmHg, urapidil heart rate \>80 and blood pressure \>140/90 mmHg, esmolol heart rate \<50, atropine mean arterial pressure \<60 mmHg, ephedrine will be administered. Local infiltration anesthesia will be administered through a catheter placed at the end of surgery, using bupivacaine at a concentration=2mg/ml and dosage=1.5 mg/kg/24 hours

Drug: non Opioids

opioid anaesthesia

İnduction = 1 mcg/kg remifentanil and/or 1-5 mg fentanyl, 2-3 mg/kg propofol, intravenous 1 mg/kg lidocaine, 2-3 mg/kg propofol, and a 0.6 mg/kg rocuronium.1 g acetaminophen, 4 mg ondansetron. Blocks will include bilateral transverse thoracic muscle plane block and/or bilateral serratus anterior plane block with 0.5% bupivacaine (max 2 mg/kg) under ultrasound guidance. Intravenous remifentanil (0.02-2 mcg/kg/hr) and propofol (1.5-12 mg/kg/hr) infusions will be adjusted based on hemodynamic parameters to achieve a target BIS value of 40-60. if: heart rate \<80 and blood pressure \>140/90 mmHg, urapidil heart rate \>80 and blood pressure \>140/90 mmHg, esmolol heart rate \<50, atropine mean arterial pressure \<60 mmHg, ephedrine will be administered. Local infiltration anesthesia will be administered through a catheter placed at the end of surgery, using bupivacaine at a concentration=2mg/ml and dosage=1.5 mg/kg/24 hours

Drug: Opioid

Interventions

non Opioids DRUG

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

Also known as: opioid anaesthesia

opioid free anaesthesia

Opioid DRUG

Routine general anesthesia in cardiac surgery

opioid anaesthesia

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients aged 18 to 80 with ASA 1, 2, or 3 status who undergo open-heart surgery with cardiopulmonary bypass and consent to participate in the study by signing the informed consent form.

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Ankara City Hospital Bilkent: lead

Study Sites (1)

Ankara Bilkent City Hospital

Ankara, Cankaya, 06800, Turkey (Türkiye)

Location

Related Publications (2)

• Mulier JP. Is opioid-free general anesthesia for breast and gynecological surgery a viable option? Curr Opin Anaesthesiol. 2019 Jun;32(3):257-262. doi: 10.1097/ACO.0000000000000716.

  PMID: 31045633 RESULT

• Chanowski EJP, Horn JL, Boyd JH, Tsui BCH, Brodt JL. Opioid-Free Ultra-Fast-Track On-Pump Coronary Artery Bypass Grafting Using Erector Spinae Plane Catheters. J Cardiothorac Vasc Anesth. 2019 Jul;33(7):1988-1990. doi: 10.1053/j.jvca.2018.10.012. Epub 2018 Oct 13. No abstract available.

  PMID: 30424939 RESULT

MeSH Terms

Interventions

Analgesics, Opioid

Intervention Hierarchy (Ancestors)

Narcotics; Central Nervous System Depressants; Physiological Effects of Drugs; Pharmacologic Actions; Chemical Actions and Uses; Analgesics; Sensory System Agents; Peripheral Nervous System Agents; Central Nervous System Agents; Therapeutic Uses

Study Officials

• Seda Kurtbeyoglu, doctor

  Ankara City Hospital Bilkent

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: November 9, 2024
• First Posted: November 12, 2024
• Study Start: April 3, 2024
• Primary Completion: April 3, 2024
• Study Completion: April 3, 2025
• Last Updated: May 6, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)