Management of Pain in Lumbar Arthrodesis (KETASONA)

Ketamine and Dexametasone in the Management of Pain in Lumbar Arthrodesis

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.

Study Overview

• Status: Recruiting
• Conditions: Pain, Postoperative
• Intervention / Treatment: Drug: Ketamine; Drug: Dexamethasone; Drug: Physiologic saline

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 Type: Interventional
• Enrollment (Estimated): 128
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Cristina Martinez, Sc; Phone Number: 2343 972940200; Email: cmartinez@idibgi.org
• Study Contact Backup: Name: Emili Leon, MD; Phone Number: 972940200; Email: emili_leon@yahoo.es

Study Locations

• Spain
  • Girona, Spain, 17007
    • Recruiting
    • Hospital Dr Josep Trueta
    • Principal Investigator: Emili Leon, MD
    • Sub-Investigator: Anna Bellod, MD
    • Sub-Investigator: Noelia Rios, MD
    • Contact: Cristina Martinez, MSc; Phone Number: 2343 972940200; Email: cmartinez@idibgi.org

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

4

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Efficacy of Morphic Chloride (PCA) to treat pain during the post-operative period. Consumption of morphics will be evaluated	Consumption of morphics	4 hours post operative

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of postoperative nausea and vomiting (PONV).	Incidence of postoperative nausea and vomiting	4 hours post operative
Efficay of study treatment regarding pain at 3 postoperative 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 months
Adverse side effects:Hallucinations / Delirium.Sedation. Diplopia, Hyperglycemia Respiratory depression (Sat <90%)	Rate of patients that presented adverse events	4 hours post operative

Collaborators and Investigators

• Sponsor: Institut d'Investigació Biomèdica de Girona Dr. Josep Trueta
• Investigators: Principal Investigator: Emili Leon, MD, Hospital Dr Josep Trueta and Hospital Santa Caterina

Study record dates

Study Major Dates

• Study Start (Actual): July 4, 2013
• Primary Completion (Estimated): July 31, 2025
• Study Completion (Estimated): December 31, 2025

Study Registration Dates

• First Submitted: August 6, 2020
• First Submitted That Met QC Criteria: February 9, 2021
• First Posted (Actual): February 12, 2021

Study Record Updates

• Last Update Posted (Actual): February 8, 2024
• Last Update Submitted That Met QC Criteria: February 7, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Pain; Neurologic Manifestations; Pain, Postoperative; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Autonomic Agents; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Anesthetics, Dissociative; Anesthetics, Intravenous; Anesthetics, General; Anesthetics; Excitatory Amino Acid Antagonists; Excitatory Amino Acid Agents; Anti-Inflammatory Agents; Antineoplastic Agents; Antiemetics; Gastrointestinal Agents; Glucocorticoids; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Antineoplastic Agents, Hormonal; Ketamine; Dexamethasone
• Other Study ID Numbers: EudraCT number 2012-002518-38

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No