Could a single dose of two common drugs tame Post-Surgery back pain?
NCT ID NCT01811251
First seen Aug 10, 2026 · Last updated Aug 11, 2026 · Updated 1 time
Summary
This phase 3 trial tests whether a single dose of dexamethasone, pregabalin, or both can reduce pain during the first movement after lumbar disc surgery. Adults aged 18 to 85 undergoing this surgery may receive one of these treatments, and their pain will be tracked for 48 hours. The goal is to find a simple, low-cost way to improve pain control and reduce the need for stronger opioids.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- A single dose of dexamethasone, pregabalin, or a combination of both, given before or during lumbar disc surgery to reduce postoperative pain.
- What this could lead to
- If effective, this could establish a simple, inexpensive pain management protocol that reduces the need for morphine and improves recovery after back surgery.
- What could go wrong
- The trial is relatively small and focuses on short-term pain relief. Results may not apply to all patients, and the drugs carry risks like nausea, dizziness, or increased blood sugar.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 3
Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.
- Participants
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162 people
The number who actually took part.
- Started
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Dec 2012
- Finished
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Oct 2017
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 85 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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CHU Clermont-Ferrand
Clermont-Ferrand, 63003, France