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Management of Pain in Lumbar Arthrodesis (KETASONA)

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ClinicalTrials.gov Identifier: NCT04751175
Recruitment Status : Recruiting
First Posted : February 12, 2021
Last Update Posted : April 15, 2021
Sponsor:
Information provided by (Responsible Party):
Dr Emili Leon, Institut d'Investigació Biomèdica de Girona Dr. Josep Trueta

Study Description
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Brief Summary:
KETAMINE AND DEXAMETASONE IN THE MANAGEMENT OF PAIN IN LUMBAR ARTHRODESISPhase IV prospective randomized controlled single-center clinical trial to determine the effect of intravenous ketamine and dexamethasone administration perioperatively in patients undergoing lumbar arthrodesis.

Condition or disease Intervention/treatment Phase
Pain, Postoperative Drug: Ketamine Drug: Dexamethasone Drug: Physiologic saline Phase 4

Detailed Description:
The need to carry out this study is to evaluate the analgesic effects after the administration of ketamine and dexamethasone intravenously perioperatively in patients undergoing lumbar arthrodesis and, likewise, study the incidence of pain and protocolize perioperative analgesia.
Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 128 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Single-center, controlled, prospective and randomized clinical trial, phase IV, to determine the effect of perioperative intravenous administration of ketamine and dexamethasone in patients undergoing lumbar arthrodesis
Masking: Double (Participant, Investigator)
Masking Description: To preserve the masking of the study, the randomization system has been carried out by the pharmacy service personnel using the EPIDAT 4.0 program and only the personnel responsible for the pharmacy will know the randomization tables and codes. The main investigator will have the emergency codes in case of need by contacting the pharmacy service
Primary Purpose: Treatment
Official Title: Ketamine and Dexametasone in the Management of Pain in Lumbar Arthrodesis
Actual Study Start Date : July 4, 2013
Estimated Primary Completion Date : July 31, 2025
Estimated Study Completion Date : December 31, 2025

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Ketamina bolus plus Dexamethasone bolus plus infusion ketamine
Ketamine bolus (0.5 mg / kg) + dexamethasone 0.1 mg / kg bolus + ketamine infusion (0.1 mg / kg / h) up to three hours after admission to the Post-Anesthesia Resuscitation Unit (URPA)
 Drug: Ketamine
Ketamine, being a non-competitive antagonist of NMDA receptors, could represent a good option as an opioid treatment enhancer for acute postoperative pain and avoid chronic pain, by reducing the '' wind-up '' phenomenon of central sensitization

Drug: Dexamethasone

A meta-analysis published in September 2011 affirms that the administration of dexamethasone at a dose of 0.1 mg / kg is an effective complement to multimodal analgesia strategies to reduce postoperative pain and opioid consumption after surgery.

Preoperative administration of the drug produces a more consistent analgesic effect than intraoperative administration
Experimental: Ketamine bolus plus ketamine infusion
Ketamine bolus (0.5 mg / kg) + physiological serum bolus + ketamine infusion (0.1 mg / kg / h) up to three hours after admission to the URPA.
 Drug: Ketamine
Ketamine, being a non-competitive antagonist of NMDA receptors, could represent a good option as an opioid treatment enhancer for acute postoperative pain and avoid chronic pain, by reducing the '' wind-up '' phenomenon of central sensitization

Drug: Physiologic saline
placebo
Active Comparator: Dexametasone arm
Saline bolus + dexamethasone bolus 0.1 mg / kg + saline infusion up to three hours after admission in URPA
 Drug: Dexamethasone

A meta-analysis published in September 2011 affirms that the administration of dexamethasone at a dose of 0.1 mg / kg is an effective complement to multimodal analgesia strategies to reduce postoperative pain and opioid consumption after surgery.

Preoperative administration of the drug produces a more consistent analgesic effect than intraoperative administration


Drug: Physiologic saline
placebo
Placebo Comparator: Saline bolus
Saline bolus + saline bolus + saline infusion up to three hours after admission to the URPA
 Drug: Physiologic saline
placebo


Outcome Measures
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Primary Outcome Measures :
  1. Efficacy of Morphic Chloride (PCA) to treat pain during the post-operative period. Consumption of morphics will be evaluated [ Time Frame: 4 hours post operative ]
    Consumption of morphics


Secondary Outcome Measures :
  1. Incidence of postoperative nausea and vomiting (PONV). [ Time Frame: 4 hours post operative ]
    Incidence of postoperative nausea and vomiting

  2. Efficay of study treatment regarding pain at 3 postoperative months [ Time Frame: 3 months ]
    Pain at 3 postoperative months assessed by EVA scale pain. This is a visual analogue scale regarding pain.It consists of a 10-centimeter horizontal line, at the ends of which are the extreme expressions of a symptom. In the left is the absence or less intensity and in the right the greater intensity. The patient is asked to mark on the line the point that indicates the intensity and measure it with a millimeter ruler. The intensity is expressed in centimeters or millimeters. The evaluation will be: 1.Mild pain if the patient scores pain less than 3. 2.Moderate pain if the evaluation is between 4 and 7. 3.Severe pain if the evaluation is equal to or greater than 8.

  3. Adverse side effects:Hallucinations / Delirium.Sedation. Diplopia, Hyperglycemia Respiratory depression (Sat <90%) [ Time Frame: 4 hours post operative ]
    Rate of patients that presented adverse events


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Male or female
  • Age> 18 years
  • ASA I-III.
  • Lumbar arthrodesis.
  • Patients who have signed the preoperative informed consent for participation in the study.

Exclusion Criteria:

  • Unstable coronary heart disease
  • Glaucoma
  • History of allergy to ketamine, dexamethasone, or morphic chloride
  • Dementia or inability to understand IC and study
  • Pluricomplicated diabetes mellitus difficult to control
  • Patients who have taken an experimental drug 30 days before the start of the study or who are included in any type of study of an experimental drug
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04751175


Contacts
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Contact: Cristina Martinez, Sc 972940200 ext 2343 cmartinez@idibgi.org
Contact: Emili Leon, MD 972940200 emili_leon@yahoo.es

Locations
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Spain
Hospital Dr Josep Trueta Recruiting
Girona, Spain, 17007
Contact: Cristina Martinez, MSc    972940200 ext 2343    cmartinez@idibgi.org   
Principal Investigator: Emili Leon, MD         
Sub-Investigator: Anna Bellod, MD         
Sub-Investigator: Noelia Rios, MD         
Sponsors and Collaborators
Institut d'Investigació Biomèdica de Girona Dr. Josep Trueta
Investigators
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Principal Investigator: Emili Leon, MD Hospital Dr Josep Trueta and Hospital Santa Caterina
More Information
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Responsible Party: Dr Emili Leon, Principal Investigator, Institut d'Investigació Biomèdica de Girona Dr. Josep Trueta
ClinicalTrials.gov Identifier: NCT04751175    
Other Study ID Numbers: EudraCT number 2012-002518-38
First Posted: February 12, 2021    Key Record Dates
Last Update Posted: April 15, 2021
Last Verified: April 2021

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Pain, Postoperative
Postoperative Complications
Pathologic Processes
Pain
Neurologic Manifestations
Dexamethasone
Ketamine
Anti-Inflammatory Agents
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Glucocorticoids
Hormones
 Hormones, Hormone Substitutes, and Hormone Antagonists
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Analgesics
Sensory System Agents
Anesthetics, Dissociative
Anesthetics, Intravenous
Anesthetics, General
Anesthetics
Central Nervous System Depressants
Excitatory Amino Acid Antagonists
Excitatory Amino Acid Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action