Clinical trial NCT06683911: Opioids Continue to Play a Primary Role in the Management of Perioperative Pain Due to Opioid-Free Anesthesia in Open Heart Surgery.
Official title: Comparison of the Postoperative Effects of Opioid-Free Anesthesia and Opioid-Based Anesthesia in Patients Undergoing Open-Heart Surgery With Cardiopulmonary Bypass
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Undergoing Open-Heart Surgery
Keywords: Open-Heart Surgery, opioid free anesthesia
Lead sponsor: Ankara City Hospital Bilkent
Sponsor class: OTHER
First posted: 2024-11-12
Enrollment: 98
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

Detailed description: 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.

Eligibility criteria: 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.

Primary outcomes:
measure: extubation time
timeFrame: postoperative 7 days
measure: mobilization
timeFrame: postoperative 7 days
measure: first bowel movement
timeFrame: postoperative 7 days
measure: vomiting
timeFrame: postoperative 1 days
measure: nausea
timeFrame: postoperative 1 days
measure: Itching
timeFrame: postoperative 1 days
measure: visual analog scale
timeFrame: postoperative 7 days
measure: opening eyes first time
timeFrame: postoperative 1 days
measure: Shivering
timeFrame: postoperative 1 days
measure: additional analgesics
timeFrame: postoperative 1 days
measure: The Behavioral Pain Scale (BPS)
timeFrame: postoperative 1 days
Secondary outcomes:
measure: glascow coma scale
timeFrame: postoperative 7 days
measure: critical care length of stay
timeFrame: postoperative 7 days
measure: hospital length of stay
timeFrame: postoperative 7 days
measure: QOR-15
timeFrame: postoperative 7 days
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Ankara Bilkent City Hospital
state: Cankaya
Study officials:
affiliation: Ankara City Hospital Bilkent
name: Seda Kurtbeyoglu, doctor
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.