Short-term Effectiveness of Gabapentin Versus Placebo in Acute Lumbosacral Radiculalgia by Herniation Disc (GRADE) (GRADE)

  • STATUS
    Recruiting
  • End date
    Feb 27, 2025
  • participants needed
    144
  • sponsor
    Lille Catholic University
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Updated on 27 April 2022
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Summary

The study consists in evaluating the analgesic efficacy of Gabapentin versus Placebo in the short term (72h) acute lumbosacral radiculalgia due to disc herniation.

In addition to the usual analgesic treatment, the patient will receive gabapentin or placebo.

During the three days of treatment, an evaluation of the pain and the tolerance will be performed within the two groups: experimental and control.

Details
Condition Radiculopathy of Lumbosacral Spine Due to Disc Disorder
Treatment Placebo, Gabapentin 300mg
Clinical Study IdentifierNCT04865042
SponsorLille Catholic University
Last Modified on27 April 2022

Eligibility

 Yes No Not Sure

Inclusion Criteria

Age ≥ 18 years
Radiculalgia or lumboradiculalgia less than 3 months (pain of a lower limb systematized to a radicular territory, possibly associated with lumbar pain)
Inpatient management for a minimum of 72 hours after inclusion
Initial radiculalgia VAS ≥ 4 (moderate to severe pain)
Concordant disc herniation between clinical symptomatology and imaging (CT or MRI) less than 3 months
Written consent signed by the patient
Affiliation to a social security system
For women of childbearing age, use of effective contraception

Exclusion Criteria

Motor neurological deficit (≤ 3/5) or cauda equina syndrome (emergency surgical indications)
History of pre-existing neuropathic pain in the lower limb affected by radiculalgia
Lumbar infiltration performed within 72 hours prior to inclusion or unable to be performed after 72 hours
Patient already on Gabapentin or Pregabalin, or having taken these treatments in the 7 days prior to inclusion
Contraindication to Gabapentin (Hypersensitivity to the active substance or to any of the excipients: corn starch, talc, yellow iron oxide, titanium dioxide, sodium lauryl sulfate, gelatin, shellac, propylene glycol, black iron oxide and potassium hydroxide)
Creatinine clearance < 30ml/min
Hemodialysis patient
Body weight < 50kgs
Transplant patient
Patient under guardianship or curatorship
Pregnant or breastfeeding woman
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