Co-analgesic Effects of Dexamethasone and Pregabalin After Lumbar Slipped Disc Surgery (NCT01811251) | Clinical Trial Compass
CompletedPhase 3
Co-analgesic Effects of Dexamethasone and Pregabalin After Lumbar Slipped Disc Surgery
France162 participantsStarted 2012-12
Plain-language 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.
Who can participate
Age range
18 Years – 85 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Patients undergoing a lumbar slipped disc surgery
* Aged 18 to 85 years.
* ASA score I-III
* Having given their consent.
* Affiliated with a social security scheme
Exclusion Criteria:
* Patients who must be operated urgently.
* Patients previously operated for lumbar spinal surgery.
* Expected duration of surgery more than 3 hours.
* Severe renal impairment defined by a creatinine clearance less than or equal to 30 mL/min.
* Taking long-term strong opiates .
* Taking long-term corticosteroids or within 48 hours before surgery.
* Taking pregabalin or gabapentin within 48 hours before surgery.
* Drug addiction.
* Patients with cognitive impairment (judged by the investigator) that may interfere with:
informed consent, the collection of endpoints, the use of auto-controlled analgesia.
* Pregnant or nursing women.
* Refusal of the protocol.
* Minor or major protected patients.
* Allergy or other cons-indication to the molecules used in the protocol.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Pain
Timeframe: at H0+2H, at H0+6h, at H0+12h, at H0+24h, at H0+48h
2
Pain evaluated by ENS during the first mobilization at the edge of the bed