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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

Tracking Information
First Submitted Date  ICMJE August 6, 2020
First Posted Date  ICMJE February 12, 2021
Last Update Posted Date April 15, 2021
Actual Study Start Date  ICMJE July 4, 2013
Estimated Primary Completion Date July 31, 2025   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 12, 2021)
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
Original Primary Outcome Measures  ICMJE
 (submitted: February 9, 2021)
Efficacy of Morphic Chloride (PCA) to treat pain during the post-operative period [ Time Frame: 4 hours post operative ]
Consumption of morphics
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: April 12, 2021)
  • Incidence of postoperative nausea and vomiting (PONV). [ Time Frame: 4 hours post operative ]
    Incidence of postoperative nausea and vomiting
  • 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.
  • 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
Original Secondary Outcome Measures  ICMJE
 (submitted: February 9, 2021)
  • Incidence of postoperative nausea and vomiting (PONV). [ Time Frame: 4 hours post operative ]
    Incidence of postoperative nausea and vomiting
  • Efficay of study treatment regarding pain at 3 postoperative months [ Time Frame: 3 months ]
    Pain at 3 postoperative months assessed by EVA scale pain
  • 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
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Management of Pain in Lumbar Arthrodesis
Official Title  ICMJE Ketamine and Dexametasone in the Management of Pain in Lumbar Arthrodesis
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.
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  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE 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
Condition  ICMJE Pain, Postoperative
Intervention  ICMJE
  • 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

  • Drug: Physiologic saline
    placebo
Study Arms  ICMJE
  • 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)
    Interventions:
    • Drug: Ketamine
    • Drug: Dexamethasone
  • 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.
    Interventions:
    • Drug: Ketamine
    • Drug: Physiologic saline
  • Active Comparator: Dexametasone arm
    Saline bolus + dexamethasone bolus 0.1 mg / kg + saline infusion up to three hours after admission in URPA
    Interventions:
    • Drug: Dexamethasone
    • Drug: Physiologic saline
  • Placebo Comparator: Saline bolus
    Saline bolus + saline bolus + saline infusion up to three hours after admission to the URPA
    Intervention: Drug: Physiologic saline
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: February 9, 2021)
128
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 31, 2025
Estimated Primary Completion Date July 31, 2025   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Cristina Martinez, Sc 972940200 ext 2343 cmartinez@idibgi.org
Contact: Emili Leon, MD 972940200 emili_leon@yahoo.es
Listed Location Countries  ICMJE Spain
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04751175
Other Study ID Numbers  ICMJE EudraCT number 2012-002518-38
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Current Responsible Party Dr Emili Leon, Institut d'Investigació Biomèdica de Girona Dr. Josep Trueta
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Institut d'Investigació Biomèdica de Girona Dr. Josep Trueta
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Emili Leon, MD Hospital Dr Josep Trueta and Hospital Santa Caterina
PRS Account Institut d'Investigació Biomèdica de Girona Dr. Josep Trueta
Verification Date April 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP