Pain in the lumbar arthrodesis MedDRA version: 14.1 Level: PT Classification code 10061683 Term: Arthrodesis System Organ Class: 10042613 - Surgical and medical procedures
Conditions
Interventions
Trade Name: FORTECORTIN
Pharmaceutical Form: Concentrate for solution for infusion
INN or Proposed INN: AMETHASONE SODIUM PHOSPHATE
Other descriptive name: DEXAMETHASONE SODIUM PHOSPHATE
Concentration
Sponsors
Hospital Universitari de Girona Dr. Josep Trueta
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: ? 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
Exclusion criteria
Exclusion criteria: ? 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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. 2 Determine the incidence of pain: To study the reduction of acute postoperative pain, neuropathic pain and chronic pain in patients undergoing lumbar arthrodesis. 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
| Measure | Time frame |
|---|---|
| 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) | — |
Countries
Spain
Contacts
Public ContactCristina Martinez
Hospital Universitari de Girona
Outcome results
None listed