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Completed

NCT Number: NCT04751175

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.

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Key information

Conditions

Pain, Postoperative Neurologic Manifestations Pain Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Hospital Dr Josep Trueta

Girona, 17007, Spain

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

ketamine

Drug

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

Dexamethasone

Drug

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

Physiologic saline

Drug

placebo

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Institut d'Investigació Biomèdica de Girona Dr. Josep Trueta

Other

Registry information

Official study title

Ketamine and Dexametasone in the Management of Pain in Lumbar Arthrodesis

Acronym: KETASONA

Important dates

Study start
2013
Primary completion
2025
Study completion
2025
First posted
Feb 12, 2021
Registry last updated
Mar 27, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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