Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
60 participants
INTERVENTIONAL
2022-08-01
2024-08-01
Brief Summary
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Detailed Description
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This double blind clinical trial aims to investigate the possible reduction of opioid use during lumbar spine surgery by administering ketamine, lidocaine and dexmedetomidine. Sixty patients will be randomly allocated into two groups. The control group will receive a continuous infusion of remifentanil, while the Dexmedetomidine-Ketamine-Lidocaine (DKL) group will receive a continuous infusion of ketamine, lidocaine and dexmedetomidine, during the surgery and shortly after
Both infusions will be administered blindly. Fentanyl and morphine will be administered to each patient so as to maintain hemodynamic stability and pain relief. The study will eventually compare the need for bolus doses of fentanyl during the surgery and morphine shortly after in each group.
Multiple hemodynamic parameters, analgesic consumption, possible side effects, patient satisfaction and the Oswestry low back pain disability questionnaire will be recorded.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
QUADRUPLE
Study Groups
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dexmedetomidine-ketamine-lidocaine (DKL) group
combination of dexmedetomidine, ketamine and lidocaine in one syringe
dexmedetomidine-ketamine-lidocaine
In the DKL group, patients will be administered in a total volume of 20 mL,1mL/10 kg of the solution containing ketamine, lidocaine and dexmedetomidine at predefined concentrations. As maintenance, they will be receiving 1mL/10kg/h of the aforementioned solution
remifentanil group
syringe of remifentanil
Remifentanil
In the Remifentanil group, patients will be administered in a total volume of 20 mL, 2 mcg/kg of fentanyl. As maintenance, they will be receiving 1 mL/10kg/h of a remifentanil solution
Interventions
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dexmedetomidine-ketamine-lidocaine
In the DKL group, patients will be administered in a total volume of 20 mL,1mL/10 kg of the solution containing ketamine, lidocaine and dexmedetomidine at predefined concentrations. As maintenance, they will be receiving 1mL/10kg/h of the aforementioned solution
Remifentanil
In the Remifentanil group, patients will be administered in a total volume of 20 mL, 2 mcg/kg of fentanyl. As maintenance, they will be receiving 1 mL/10kg/h of a remifentanil solution
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* American Society of Anesthesiologists (ASA) class I-III
* elective spine surgery
Exclusion Criteria
* contraindications to local anesthetic administration
* systematic use of analgesic agents preoperatively
* chronic pain syndromes preoperatively
* neurological or psychiatric disease on treatment
* pregnancy
* severe hepatic or renal disease
* history of cardiovascular diseases/ arrhythmias/ conduction abnormalities
* bradycardia(\<55 beats/minute)
* drug or alcohol abuse
* language or communication barriers lack of informed consent
18 Years
75 Years
ALL
Yes
Sponsors
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Aretaieion University Hospital
OTHER
Responsible Party
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Dr Kassiani Theodoraki
Professor of Anesthesiology
Principal Investigators
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Kassiani Theodoraki
Role: PRINCIPAL_INVESTIGATOR
Aretaieion University Hospital, Athens, Greece
Locations
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Evangelismos General Hospital
Athens, , Greece
Countries
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Central Contacts
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Facility Contacts
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Athanasios Vaiopoulos, MD
Role: primary
References
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Licina A, Silvers A. Perioperative Intravenous Lidocaine Infusion for Postoperative Analgesia in Patients Undergoing Surgery of the Spine: Systematic Review and Meta-Analysis. Pain Med. 2022 Jan 3;23(1):45-56. doi: 10.1093/pm/pnab210.
Lavand'homme P, Steyaert A. Opioid-free anesthesia opioid side effects: Tolerance and hyperalgesia. Best Pract Res Clin Anaesthesiol. 2017 Dec;31(4):487-498. doi: 10.1016/j.bpa.2017.05.003. Epub 2017 May 17.
Jabbour HJ, Naccache NM, Jawish RJ, Abou Zeid HA, Jabbour KB, Rabbaa-Khabbaz LG, Ghanem IB, Yazbeck PH. Ketamine and magnesium association reduces morphine consumption after scoliosis surgery: prospective randomised double-blind study. Acta Anaesthesiol Scand. 2014 May;58(5):572-9. doi: 10.1111/aas.12304. Epub 2014 Mar 17.
Waelkens P, Alsabbagh E, Sauter A, Joshi GP, Beloeil H; PROSPECT Working group * * of the European Society of Regional Anaesthesia and Pain therapy (ESRA). Pain management after complex spine surgery: A systematic review and procedure-specific postoperative pain management recommendations. Eur J Anaesthesiol. 2021 Sep 1;38(9):985-994. doi: 10.1097/EJA.0000000000001448.
Other Identifiers
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254/13-07-2022
Identifier Type: -
Identifier Source: org_study_id