Pain, Postoperative
Conditions
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.
Interventions
DRUGKetamine
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
DRUGDexamethasone
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
placebo
Sponsors
Institut d'Investigació Biomèdica de Girona Dr. Josep Trueta
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Masking description
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
Intervention model description
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
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
Spain
Contacts
PRINCIPAL_INVESTIGATOREmili Leon, MD
Hospital Dr Josep Trueta and Hospital Santa Caterina
Outcome results
None listed