Status:
UNKNOWN
Short-term Effectiveness of Gabapentin Versus Placebo in Acute Lumbosacral Radiculalgia by Herniation Disc (GRADE)
Lead Sponsor:
Lille Catholic University
Conditions:
Radiculopathy of Lumbosacral Spine Due to Disc Disorder
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief 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 ...
Detailed Description
The objective of the study is to evaluate the analgesic efficacy of GABAPENTIN versus Placebo in 72h for hospitalised patients suffering from acute lumbosacral radiculalgia due to disc herniation. Af...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
February 2 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
February 1 2025
Estimated Enrollment :
144 Patients enrolled
Trial Details
Trial ID
NCT04865042
Start Date
February 2 2022
End Date
February 1 2025
Last Update
June 23 2023
Active Locations (5)
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1
CH Arras-rheumatology
Arras, France
2
CH Béthune-rheumatology
Béthune, France
3
CHU Caen-rheumatology
Caen, France
4
CH Dunkerque-rheumatology
Dunkirk, France