Study of ketamine and dexamethasone to treat pain from back surgery (lumbar fusion)
- Conditions
- Pain in the lumbar arthrodesisMedDRA version: 14.1Level: PTClassification code 10061683Term: ArthrodesisSystem Organ Class: 10042613 - Surgical and medical proceduresTherapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Anesthesia and Analgesia [E03]
- Registration Number
- EUCTR2012-002518-38-ES
- Lead Sponsor
- Hospital Universitari de Girona Dr. Josep Trueta
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- Not specified
? Male or female
? Age> 18 years
? ASA I-III.
? lumbar arthrodesis.
? Patients who have signed informed consent before surgery, to participate in the study.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 128
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 128
? unstable coronary disease
? Glaucoma
? History of allergy to ketamine, morphine or dexamethasone
? Dementia or inability to understand and study the IC
? Diabetes mellitus pluricomplicada difficult to control
? Patients who have taken an experimental drug in phase 30 days before the start of the study or included in any study of an experimental drug.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: The objective for this study is to evaluate the analgesic effects after administration of ketamine and intravenous dexamethasone perioperatively in patients undergoing lumbar arthrodesis and also, to study the incidence of pain and formalize perioperative analgesia.;Secondary Objective: 1 Determine the effectiveness of ketamine and intravenous dexamethasone perioperatively in patients undergoing lumbar arthrodesis.<br>2 Determine the incidence of pain: To study the reduction of acute postoperative pain, neuropathic pain and chronic pain in patients undergoing lumbar arthrodesis.<br>3. Formalize the post-operative analgesia;Primary end point(s): pain intensity will be assessed using the VAS questionnaire and consumption of morphine;Timepoint(s) of evaluation of this end point: pain intensity will be assessed by VAS questionnaire and morphine consumption the day before surgery, the same day of surgery and 3 months after the intervention
- Secondary Outcome Measures
Name Time Method Secondary end point(s): There are no secondary endpoints;Timepoint(s) of evaluation of this end point: Primary Endpoint will be assess once the patient completes participation in the study (3 months post intervention)