Management of Pain in Lumbar Arthrodesis

Pain, Postoperative Clinical Trial

— KETASONA  

Official title:

Ketamine and Dexametasone in the Management of Pain in Lumbar Arthrodesis

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04751175
• Other study ID #: EudraCT number 2012-002518-38
• Status: Recruiting
• Phase: Phase 4
• Start date: July 4, 2013
• Est. completion date: December 31, 2025

Study information

• Verified date: February 2024
• Source: Institut d'Investigació Biomèdica de Girona Dr. Josep Trueta
• Contact: Cristina Martinez, Sc
• Phone: 972940200
• Email: cmartinez[@]idibgi.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 128
• Est. completion date: December 31, 2025
• Est. primary completion date: July 31, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Pain, Postoperative

Intervention

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
• 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
• Physiologic saline
placebo

Locations

Country	Name	City	State
Spain	Hospital Dr Josep Trueta	Girona

Sponsors (1)

Lead Sponsor	Collaborator
Institut d'Investigació Biomèdica de Girona Dr. Josep Trueta

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Incidence of postoperative nausea and vomiting (PONV).	Incidence of postoperative nausea and vomiting	4 hours post operative
Secondary	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
Secondary	Adverse side effects:Hallucinations / Delirium.Sedation. Diplopia, Hyperglycemia Respiratory depression (Sat <90%)	Rate of patients that presented adverse events	4 hours post operative