Opioid Sparing Anesthesia in Cervical Spine Surgery

NCT05717361 | Unknown

• 1 other identifier: 254/13-07-2022Β
• 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 lidocaine and ketamine in the same syringe versus remifentanyl analgesia in cervical spine surgery.

Conditions

Pain, Postoperative; Pain, Acute; Pain, Chronic; Pain, Nociceptive; Ketamine; Lidocaine; Analgesia; Analgesics; Cervical 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)

ketamine-lidocaine (KL) group combination of ketamine and lidocaine in one syringe

ACTIVE COMPARATOR

Drug: ketamine-lidocaine

: remifentanil group syringe of remifentanil

ACTIVE COMPARATOR

Drug: Remifentanil

Interventions

ketamine-lidocaine DRUG

In the KL group, patients will be administered in a total volume of 20 mL,1mL/10 kg of the solution containing ketamine, lidocaine at predefined concentrations. As maintenance, they will be receiving 1mL/10kg/h of the aforementioned solution

Also known as: KL group

ketamine-lidocaine (KL) group combination of ketamine and lidocaine in one syringe

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 syringe of remifentanil

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

• Evangelismos Hospital: lead
• Aretaieion University Hospital: collaborator

Study Sites (1)

Evangelismos General Hospital

Athens, Greece

RECRUITING

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

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: Anesthesia Resident

Study Record Dates

• First Submitted: January 28, 2023
• First Posted: February 8, 2023
• Study Start: November 1, 2022
• Primary Completion: November 1, 2024
• Study Completion: November 1, 2024
• Last Updated: February 8, 2023

Record last verified: 2023-01

Locations

GR (1)