Opioid Sparing Anesthesia in Lumbar Spine Surgery

NCT05594407 | Unknown

• 1 other identifier: 254/13-07-2022
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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

Conditions

Dexmedetomidine; Pain, Postoperative; Pain, Acute; Pain, Chronic; Pain, Nociceptive; Ketamine; Lidocaine; Analgesia; Analgesics; Lumbar Spine Surgery

Outcome Measures

Primary Outcomes (5)

• pain score on arrival to Post-Anesthesia Care Unit (PACU)

  pain score by the use of Numeric Rating Scale (NRS) on arrival to PACU, ranging from 0 to 10, where 0 means "no pain" and 10 means "worst pain imaginable"

  immediately postoperatively

• pain score at discharge from Post-Anesthesia Care Unit (PACU)

  pain score by the use of Numeric Rating Scale (NRS) at discharge from PACU, ranging from 0 to 10, where 0 means "no pain" and 10 means "worst pain imaginable"

  at discharge from Post Anesthesia Care Unit (PACU), approximately 1 hour postoperatively

• pain score 3 hours postoperatively

  pain score by the use of Numeric Rating Scale (NRS) 3 hours postoperatively, ranging from 0 to 10, where 0 means "no pain" and 10 means "worst pain imaginable"

  3 hours postoperatively

• pain score 6 hours postoperatively

  pain score by the use of Numeric Rating Scale (NRS) 6 hours postoperatively, ranging from 0 to 10, where 0 means "no pain" and 10 means "worst pain imaginable"

  6 hours postoperatively

• pain score 24 hours postoperatively

  pain score by the use of Numeric Rating Scale (NRS) 24 hours postoperatively, ranging from 0 to 10, where 0 means "no pain" and 10 means "worst pain imaginable"

  24 hours postoperatively

Secondary Outcomes (7)

• sedation on arrival to Post-Anesthesia Care Unit

  immediately postoperatively

• sedation at discharge from Post-Anesthesia Care (PACU) Unit

  at discharge from Post Anesthesia Care Unit (PACU), approximately 1 hour postoperatively

• time to first request for analgesia

  during stay in Post-Anesthesia Care Unit (PACU), approximately 1 hour postoperatively

• morphine consumption in Post-Anesthesia Care Unit (PACU)

  immediately postoperatively

• tramadol consumption in the first 48 hours

  48 hours postoperatively

Study Arms (2)

dexmedetomidine-ketamine-lidocaine (DKL) group

ACTIVE COMPARATOR

combination of dexmedetomidine, ketamine and lidocaine in one syringe

Drug: dexmedetomidine-ketamine-lidocaine

remifentanil group

ACTIVE COMPARATOR

syringe of remifentanil

Drug: Remifentanil

Interventions

dexmedetomidine-ketamine-lidocaine DRUG

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

Also known as: DKL group

dexmedetomidine-ketamine-lidocaine (DKL) group

Remifentanil DRUG

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

Also known as: Remifentanil group

remifentanil group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Aretaieion University Hospital: lead

Study Sites (1)

Evangelismos General Hospital

Athens, Greece

RECRUITING

Related Publications (4)

• 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.

  PMID: 34196720 BACKGROUND

• 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.

  PMID: 29739537 BACKGROUND

• 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.

  PMID: 24635528 BACKGROUND

• 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.

  PMID: 34397527 BACKGROUND

MeSH Terms

Conditions

Pain, Postoperative; Acute Pain; Chronic Pain; Nociceptive Pain; Agnosia

Interventions

Remifentanil

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms; Perceptual Disorders; Neurobehavioral Manifestations; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Propionates; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Kassiani Theodoraki

  Aretaieion University Hospital, Athens, Greece

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Kassiani Theodoraki, PhD, DESA

CONTACT

+306974634162; ktheodoraki@hotmail.com

Athanasios Vaiopoulos, MD

CONTACT

thanasisvaio@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Anesthesiology

Study Record Dates

• First Submitted: October 21, 2022
• First Posted: October 26, 2022
• Study Start: August 1, 2022
• Primary Completion: August 1, 2024
• Study Completion: August 1, 2024
• Last Updated: October 31, 2022

Record last verified: 2022-10

Locations

GR (1)