Clinical trial NCT05594407: Opioid Sparing Anesthesia in Lumbar Spine Surgery
Official title: The Effect of a Regimen of Opioid Sparing Anesthesia on Postoperative Recovery
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Pain, Postoperative
Pain, Acute
Pain, Chronic
Pain, Nociceptive
Ketamine
Lidocaine
Dexmedetomidine
Analgesia
Analgesics
Lumbar Spine Surgery
Lead sponsor: Aretaieion University Hospital
Sponsor class: OTHER
First posted: 2022-10-26
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The aim of this double blind randomized study will be to investigate the effect of an opioid-free anesthesia regimen with a mixture of dexmedetomidine-lidocaine-ketamine in the same syringe versus remifentanil analgesia in lumbar spine surgery

Detailed description: Lumbar spine surgery is associated with high pain scores and perioperative disability. Ketamine, lidocaine and dexmedetomidine have all proven but varied analgesic effects. High opioid consumption has been associated with multiple side effects.

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.

Eligibility criteria: Inclusion Criteria:

* Adult patents
* American Society of Anesthesiologists (ASA) class I-III
* elective spine surgery

Exclusion Criteria:

* body mass index (BMI) \>35 kg/m2
* 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

Primary outcomes:
measure: pain score on arrival to Post-Anesthesia Care Unit (PACU)
timeFrame: immediately postoperatively
measure: pain score at discharge from Post-Anesthesia Care Unit (PACU)
timeFrame: at discharge from Post Anesthesia Care Unit (PACU), approximately 1 hour postoperatively
measure: pain score 3 hours postoperatively
timeFrame: 3 hours postoperatively
measure: pain score 6 hours postoperatively
timeFrame: 6 hours postoperatively
measure: pain score 24 hours postoperatively
timeFrame: 24 hours postoperatively
Secondary outcomes:
measure: sedation on arrival to Post-Anesthesia Care Unit
timeFrame: immediately postoperatively
measure: sedation at discharge from Post-Anesthesia Care (PACU) Unit
timeFrame: at discharge from Post Anesthesia Care Unit (PACU), approximately 1 hour postoperatively
measure: time to first request for analgesia
timeFrame: during stay in Post-Anesthesia Care Unit (PACU), approximately 1 hour postoperatively
measure: morphine consumption in Post-Anesthesia Care Unit (PACU)
timeFrame: immediately postoperatively
measure: tramadol consumption in the first 48 hours
timeFrame: 48 hours postoperatively
measure: fentanyl requirement during surgery
timeFrame: intraoperatively
measure: satisfaction from postoperative analgesia
timeFrame: 24 hours postoperatively
Other outcomes:
Locations:
city: Athens
country: Greece
facility: Evangelismos General Hospital
Study officials:
affiliation: Aretaieion University Hospital, Athens, Greece
name: Kassiani Theodoraki
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.