Management of Pain in Lumbar Arthrodesis

Institut d'Investigació Biomèdica de Girona Dr. Josep Trueta128 enrolled

Overview

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.

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

128

Conditions

Pain, Postoperative

Interventions

KetamineDRUG

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

DexamethasoneDRUG

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 salineDRUG

placebo

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Hospital Dr Josep Trueta

Girona, Spain

Outcomes

Primary Outcomes

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

Consumption of morphics

Time frame: 4 hours post operative

Secondary Outcomes

Incidence of postoperative nausea and vomiting (PONV).

Incidence of postoperative nausea and vomiting

Time frame: 4 hours post operative

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.

Time frame: 3 months

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

Rate of patients that presented adverse events

Time frame: 4 hours post operative

Data from ClinicalTrials.gov

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