Clinical trial NCT04865042: Short-term Effectiveness of Gabapentin Versus Placebo in Acute Lumbosacral Radiculalgia by Herniation Disc (GRADE)
Official title: Short-term Effectiveness of Gabapentin Versus Placebo in Acute Lumbosacral Radiculalgia by Herniation Disc: a Prospective, Multicentric, Randomized, Controlled, Double-blind Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Radiculopathy of Lumbosacral Spine Due to Disc Disorder
Keywords: Radiculalgia
Lumbosacral spine
Disc herniation
Gabapentin
Lead sponsor: Lille Catholic University
Sponsor class: OTHER
First posted: 2021-04-29
Enrollment: 144
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 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.

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.

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).

Eligibility criteria: 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),
* 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

Primary outcomes:
measure: Change in Visual Analogical Scale (VAS) for radiculalgia
timeFrame: Day 4
Secondary outcomes:
measure: Rate of patients with at least one adverse event
timeFrame: Day 7
measure: Change in VAS for lumbalgia
timeFrame: 72 hours
measure: Responder rate for lumbalgia at Day 4.
timeFrame: Day 4
measure: VAS for radiculalgia
timeFrame: Day 7
measure: VAS for lumbalgia
timeFrame: Day 7
measure: Neuropathic Pain Symptom Inventory (NPSI) scale
timeFrame: Day 7
measure: Dn4 (neuropathic pain screening questionnaire)
timeFrame: Day 7
measure: Number of interdose of anti-nociceptive analgesics
timeFrame: Day 4
measure: Rate of patients having used at least one interdose
timeFrame: Day 4
measure: Rate of patients having reduced the associated anti-nociceptive analgesic treatment
timeFrame: Day 7
Other outcomes:
Locations:
city: Arras
country: France
facility: CH Arras-rheumatology
city: Béthune
country: France
facility: CH Béthune-rheumatology
city: Caen
country: France
facility: CHU Caen-rheumatology
city: Dunkerque
country: France
facility: CH Dunkerque-rheumatology
city: Rouen
country: France
facility: CHU Rouen-rheumatology
Study officials:
affiliation: GHICL
name: Vincent Ducoulombier, MD
role: STUDY_DIRECTOR
References: