Informations générales (source: ClinicalTrials.gov)
Short-term Effectiveness of Gabapentin Versus Placebo in Acute Lumbosacral Radiculalgia by Herniation Disc: a Prospective, Multicentric, Randomized, Controlled, Double-blind Study (GRADE)
Interventional
Phase 4
Lille Catholic University (Voir sur ClinicalTrials)
février 2022
février 2025
29 juin 2024
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.
Etablissements
| Les établissements hors Île-de-France dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
|---|---|---|---|---|---|
| CH Béthune-rheumatology - Béthune - France | Pascal, MD | Contact (sur clinicalTrials) | |||
| CH Dunkerque-rheumatology - Dunkerque - France | Rémy Leroy, MD | Contact (sur clinicalTrials) | |||
| Les établissements sans correspondance certaine dans le répertoire FINESS dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
| CH Arras-rheumatology - Arras - France | Jean-Baptiste CANDELIER, MD | Contact (sur clinicalTrials) | |||
| CHU Caen-rheumatology - Caen - France | Christian Marcelli | Contact (sur clinicalTrials) | |||
| CHU Rouen-rheumatology - Rouen - France | Gilles Avenel, MD | Contact (sur clinicalTrials) | |||
Critères
Tous
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
- 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
- Motor neurological deficit (≤ 3/5) or cauda equina syndrome (emergency surgical
indications),
- Chronic 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