The aim of the study is to show a decrease in postoperative pain during the first postoperative mobilization surgery lumbar disc herniation through a co-analgesia with a single dose of dexamethasone, pregabalin, or a combination of these two products. Pain assessed by simple numerical scale will be also evaluated during the 48 first post-operative hours. Determining an optimal co-analgesic protocol through the results of this study could help develop validation studies with larger scale such as a medico-economic component. In addition, these study protocols are easy to apply (ponctual administration) and inexpensive.
Visit 1 (J-30 J-1): pre-inclusion visit During a follow-up visit usual pathology, the doctor will propose to the patient to participate in the protocol. Information Form will be given to the patient to be read at home to maintain a sufficient time for reflection. Physician investigator check the eligibility criteria and complete a pre-screening form where he will note the following information about the patient: No pre-enrollment, name, date, reason for non-inclusion appropriate. Visit 2 (J-1): pre-anesthetic visit, the day before surgery During the pre-anesthetic routine consultation, the doctor will check the proper collection of informed consent and then inform the following information on the CRF: randomization number, age, height, weight, ideal weight theory, gender patient. Visit 3 (J0): surgery One hour before surgery, the patient will receive, according to randomization, premedication with pregabalin LYRICA ® or placebo orally. Then the patient will be conducted in the operating room for induction of general anesthesia and surgery. Immediately after induction of anesthesia, depending on randomization, the patient will receive intravenous dexamethasone or placebo. At the end of surgery, the patient is conducted in Post Anaesthesia Carry Unit (PACU) to be extubated and receive routine care after surgery. Extubation of the patient, denoted H0 represents the time when the measurement begins. The data collected from H0 are : * ENS score standing at H0, H0+30mn, H0+1h, H0+1h30, H0+2 h, H0+6 h,H0+12 h, H0+24h, H0+48 h. * ENS score mobilization at the first time the patient gets up (edge of the bed and standing if possible) * Qualification of the quality of standing 0-4 (Likert scale (0 = very poor, 1 = poor, 2 = fair, 3 = good, 4 = very good)) by the nursing staff after the first mobilization * Qualification of patient satisfaction compared to the first standing by a score of 0-4 (Likert scale (0 = very poor, 1 = poor, 2 = fair, 3 = good, 4 = very good)) * Sedation score at the end of SSPI, , at H0+24h and H0+48h * Nausea and vomiting score at H0+24 h, H0+48 h * Tolerance of the treatments undertaken : visual disturbances, lightheadedness, urinary retention, pruritus, measured at the end of SSPI at H0+24 h and H0+48 h * Consumption of morphine at H0+24 h and H0+48 h * Assessment of pain score at 6 months by score ENS at rest , assessment of neuropathic component by DN4 scale. Statement consumption of analgesic treatments.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
162
CHU Clermont-Ferrand
Clermont-Ferrand, France
Pain
Time frame: at H0+2H, at H0+6h, at H0+12h, at H0+24h, at H0+48h
Pain evaluated by ENS during the first mobilization at the edge of the bed
Time frame: at J0+1 day
Pain
Time frame: during the first mobilization with standing up at J1
Quality of the standing up (evaluated by Likert scale)
Time frame: at J0+1day
Patient satisfaction (evaluated by Likert scale)
Time frame: at J0+1 day
Consumption of morphine
Time frame: between H0+2h and H0+24h
Pain at rest
Time frame: at J0+180 days
assessment of neuropathic component DN4 scale
Time frame: at J0+180 days
statement of analgesic treatment
Time frame: at J0+180 days
Pain during mobilization
Time frame: at J0+180 days
Postoperative Nausea and Vomiting
Time frame: at H0+24h
Postoperative Nausea and Vomiting
Time frame: at H0+48h
Sedation
Time frame: at J0 at the arrival in the operating room
Sedation
Time frame: at J0 at the end of SSPI
Sedation
Time frame: at H0+24 h
Sedation
Time frame: at H0+48h
Existence of visual disturbances
Time frame: at H0, between H0 and H0+48H
Existence of lightheadedness
Time frame: at H0, between H0 and H0+48H
Existence of urinary retention
Time frame: at H0, between H0 and H0+48H
Existence of pruritus
Time frame: at H0, between H0 and H0+48H
Pain
Time frame: at H0+0h30
pain
Time frame: at H0+1h
pain
Time frame: at H0+1h30
pain
Time frame: at H0+2h
pain
Time frame: at H0+6h
pain
Time frame: at H0+12h
pain
Time frame: at H0+24h
pain
Time frame: at H0+48h
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.