Management of Pain in Lumbar Arthrodesis

Phase 4

Recruiting

• Conditions: Pain, Postoperative
• Interventions: Drug: Ketamine; Drug: Dexamethasone; Drug: Physiologic saline

• Registration Number: NCT04751175
• Lead Sponsor: Institut d'Investigació Biomèdica de Girona Dr. Josep Trueta

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 Timeline

• Study Start: 2013-07-04
• Study First Submitted: 2020-08-06
• Study First Submitted QC: 2021-02-09
• Study First Posted: 2021-02-12
• Status Verified: 2024-02
• Last Update Submitted: 2024-02-07
• Last Update Posted: 2024-02-08
• Primary Completion: 2025-07-31
• Study Completion: 2025-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 128

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Ketamina bolus plus Dexamethasone bolus plus infusion ketamine	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)
Ketamine bolus plus ketamine infusion	Physiologic saline	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.
Dexametasone arm	Dexamethasone	Saline bolus + dexamethasone bolus 0.1 mg / kg + saline infusion up to three hours after admission in URPA
Dexametasone arm	Physiologic saline	Saline bolus + dexamethasone bolus 0.1 mg / kg + saline infusion up to three hours after admission in URPA
Saline bolus	Physiologic saline	Saline bolus + saline bolus + saline infusion up to three hours after admission to the URPA
Ketamina bolus plus Dexamethasone bolus plus infusion ketamine	Dexamethasone	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)
Ketamine bolus plus ketamine infusion	Ketamine	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.

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Incidence of postoperative nausea and vomiting (PONV).	4 hours post operative	Incidence of postoperative nausea and vomiting
Efficay of study treatment regarding pain at 3 postoperative months	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%)	4 hours post operative	Rate of patients that presented adverse events

Trial Locations

Locations (1)

Hospital Dr Josep Trueta; 🇪🇸 Girona, Spain