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

Lille Catholic University

Status and phase: Enrolling; Phase 4

Conditions: Radiculopathy of Lumbosacral Spine Due to Disc Disorder

Treatments: Drug: Gabapentin 300mg; Drug: PLACEBO

Study type: Interventional

Funder types: Other

Identifiers

NCT04865042

RC-P0103

Details and patient eligibility

About

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.

Full 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).

Enrollment: 144 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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144 participants in 2 patient groups, including a placebo group

Gabapentin

Experimental group

Description:

GABAPENTIN per os\*: * DAY 1:300 mg * DAY 2: 600 mg * DAY 3: 900 mg

Treatment:

Drug: Gabapentin 300mg

Placebo

Placebo Comparator group

Description:

PLACEBO: * DAY 1:300 mg * DAY 2: 600 mg * DAY 3: 900 mg

Treatment:

Drug: PLACEBO