Short-term Effectiveness of Gabapentin Versus Placebo in Acute Lumbosacral Radiculalgia by Herniation Disc (GRADE)
NCT ID: NCT04865042
Last Updated: 2023-06-23
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE4
144 participants
INTERVENTIONAL
2022-02-02
2025-02-28
Brief Summary
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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.
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Detailed Description
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After signing the consent form, patient's clinical data will be collected and the patient will be allocated to one treatment arm by the randomisation process (ratio 1:1 and stratified on the strong opioid intake).
Two treatment arms are possible :
* Experimental group: GABAPENTINE per os
* DAY1:300 mg
* DAY 2: 600 mg
* DAY3 : 900 mg
* Control group: placebo (same dosage per day as GABAPENTINE).
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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Gabapentin
GABAPENTIN per os\*:
* DAY 1:300 mg
* DAY 2: 600 mg
* DAY 3: 900 mg
Gabapentin 300mg
The patient will receive in addition to the usual analgesic treatment, the treatment under study: Gabapentin.
During the first 3 days of his hospitalization, an evaluation of the pain and the tolerance to the treatment will be performed.
The patient will have to take the treatment as follows:
* Day 1 (1st day of hospitalization): 1 capsule/day
* Day 2: 2 capsules/day
* Day 3: 3 capsules/day 72 hours after the first treatment, a blood test will be performed.
Placebo
PLACEBO:
* DAY 1:300 mg
* DAY 2: 600 mg
* DAY 3: 900 mg
PLACEBO
The patient will receive in addition to the usual analgesic treatment, the Placebo During the first 3 days of his hospitalization, an evaluation of the pain and the tolerance to the treatment will be made.
The patient will have to take the treatment as follows:
* Day 1 (1st day of hospitalization): 1 capsule/day
* Day 2: 2 capsules/day
* Day 3: 3 capsules/day 72 hours after the first treatment, a blood test will be performed.
Interventions
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Gabapentin 300mg
The patient will receive in addition to the usual analgesic treatment, the treatment under study: Gabapentin.
During the first 3 days of his hospitalization, an evaluation of the pain and the tolerance to the treatment will be performed.
The patient will have to take the treatment as follows:
* Day 1 (1st day of hospitalization): 1 capsule/day
* Day 2: 2 capsules/day
* Day 3: 3 capsules/day 72 hours after the first treatment, a blood test will be performed.
PLACEBO
The patient will receive in addition to the usual analgesic treatment, the Placebo During the first 3 days of his hospitalization, an evaluation of the pain and the tolerance to the treatment will be made.
The patient will have to take the treatment as follows:
* Day 1 (1st day of hospitalization): 1 capsule/day
* Day 2: 2 capsules/day
* Day 3: 3 capsules/day 72 hours after the first treatment, a blood test will be performed.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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Lille Catholic University
OTHER
Responsible Party
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Principal Investigators
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Vincent Ducoulombier, MD
Role: STUDY_DIRECTOR
GHICL
Locations
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CH Arras-rheumatology
Arras, , France
CH Béthune-rheumatology
Béthune, , France
CHU Caen-rheumatology
Caen, , France
CH Dunkerque-rheumatology
Dunkirk, , France
CHU Rouen-rheumatology
Rouen, , France
Countries
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Central Contacts
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Facility Contacts
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Jean-Baptiste CANDELIER, MD
Role: primary
Pascal, MD
Role: primary
Christian Marcelli
Role: primary
Rémy Leroy, MD
Role: primary
Gilles Avenel, MD
Role: primary
References
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Ducoulombier V, Coquerelle P, Candelier JB, Avenel G, Leroy R, Juilliard A, Norberciak L, Pascart T. Gabapentin versus placebo for the treatment of acute lumbosacral radicular pain caused by disc herniation: study protocol of the GRADE randomized controlled double-blind superiority trial. Trials. 2025 Oct 24;26(1):435. doi: 10.1186/s13063-025-09139-4.
Other Identifiers
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RC-P0103
Identifier Type: -
Identifier Source: org_study_id
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