Clinical Trial: Co-analgesic Effects of Dexamethasone and Pregabalin After Lumbar Slipped Disc Surgery

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: Co-analgesic Effects of Dexamethasone and Pregabalin After Lumbar Slipped Disc Surgery

Brief 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 Summary:

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.
  • 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 ]


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • 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 ]


Original Secondary Outcome:

  • 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 ]


Information By: University Hospital, Clermont-Ferrand

Dates:
Date Received: December 4, 2012
Date Started: December 2012
Date Completion: October 2017
Last Updated: April 1, 2016
Last Verified: April 2016