Management of Pain in Lumbar Arthrodesis (KETASONA)

Institut d'Investigació Biomèdica de Girona Dr. Josep Trueta

Status and phase: Enrolling; Phase 4

Conditions: Pain, Postoperative

Treatments: Drug: Physiologic saline; Drug: Dexamethasone; Drug: Ketamine

Study type: Interventional

Funder types: Other

Identifiers

NCT04751175

EudraCT number 2012-002518-38

Details and patient eligibility

About

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.

Full 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.

Enrollment: 128 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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128 participants in 4 patient groups, including a placebo group

Ketamina bolus plus Dexamethasone bolus plus infusion ketamine

Experimental group

Description:

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)

Treatment:

Drug: Ketamine

Drug: Dexamethasone

Ketamine bolus plus ketamine infusion

Experimental group

Description:

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.

Treatment:

Drug: Ketamine

Drug: Physiologic saline

Dexametasone arm

Active Comparator group

Description:

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

Treatment:

Drug: Dexamethasone

Drug: Physiologic saline

Saline bolus

Placebo Comparator group

Description:

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

Treatment:

Drug: Physiologic saline