Co-analgesic Effects of Dexamethasone and Pregabalin After Lumbar Slipped Disc Surgery
Condition: Patients Undergoing a Lumbar Slipped Disc Surgery
MeSH terms: Intervertebral Disc Displacement
Study type: Interventional
Phase: Phase 3

Summary: 
      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.
    

Detailed description: 
      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.
    

Intervention name(s): Pregabaline (150mg), Dexamethasone (20mg/5ml; 0.2mg/kg)
Intervention type(s): Drug
Intervention MeSH terms: Dexamethasone; Pregabalin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Co-analgesia; Dexamethasone; Pregabalin; Lumbar slipped disc surgery; Post-operative pain