Management of Pain in Lumbar Arthrodesis

NCT04751175 | Completed Phase 4

• 1 other identifier: EudraCT number 2012-002518-38
• Study Type: interventional
• Target: 128
• Locations: 1 country
• Sites: 1

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.

Conditions

Pain, Postoperative

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Incidence of postoperative nausea and vomiting (PONV).

  4 hours post operative

• Efficay of study treatment regarding pain at 3 postoperative months

  3 months

• Adverse side effects:Hallucinations / Delirium.Sedation. Diplopia, Hyperglycemia Respiratory depression (Sat <90%)

  4 hours post operative

Study Arms (4)

Ketamina bolus plus Dexamethasone bolus plus infusion ketamine

EXPERIMENTAL

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; Drug: Dexamethasone

Ketamine bolus plus ketamine infusion

EXPERIMENTAL

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; Drug: Physiologic saline

Dexametasone arm

ACTIVE COMPARATOR

Saline bolus + dexamethasone bolus 0.1 mg / kg + saline infusion up to three hours after admission in URPA

Drug: Dexamethasone; Drug: Physiologic saline

Saline bolus

PLACEBO COMPARATOR

Saline bolus + saline bolus + saline infusion up to three hours after admission to the URPA

Drug: Physiologic saline

Interventions

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

Ketamina bolus plus Dexamethasone bolus plus infusion ketamine; Ketamine bolus plus ketamine infusion

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

Dexametasone arm; Ketamina bolus plus Dexamethasone bolus plus infusion ketamine

Physiologic saline DRUG

placebo

Dexametasone arm; Ketamine bolus plus ketamine infusion; Saline bolus

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Institut d'Investigació Biomèdica de Girona Dr. Josep Trueta: lead

Study Sites (1)

Hospital Dr Josep Trueta

Girona, 17007, Spain

Location

MeSH Terms

Conditions

Pain, Postoperative

Interventions

Ketamine; Dexamethasone

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated

Study Officials

• Emili Leon, MD

  Hospital Dr Josep Trueta and Hospital Santa Caterina

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: 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
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: 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

Study Record Dates

• First Submitted: August 6, 2020
• First Posted: February 12, 2021
• Study Start: July 4, 2013
• Primary Completion: July 31, 2025
• Study Completion: December 31, 2025
• Last Updated: March 27, 2026

Record last verified: 2026-03

Locations

ES (1)