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

Study Overview
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Brief Summary
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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
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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).

Official Title
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Short-term Effectiveness of Gabapentin Versus Placebo in Acute Lumbosacral Radiculalgia by Herniation Disc: a Prospective, Multicentric, Randomized, Controlled, Double-blind Study

Conditions
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Radiculopathy of Lumbosacral Spine Due to Disc Disorder

Intervention / Treatment
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* Drug: Gabapentin 300mg
* Drug: PLACEBO


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Gabapentin<br>GABAPENTIN per os*: DAY 1:300 mg DAY 2: 600 mg DAY 3: 900 mg | Drug: Gabapentin 300mg<br>* 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.<br>* Other names: NEUROTIN;|
| Placebo Comparator: Placebo<br>PLACEBO: DAY 1:300 mg DAY 2: 600 mg DAY 3: 900 mg | Drug: PLACEBO<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Visual Analogical Scale (VAS) for radiculalgia | Visual analogue scales are 10-cm lines anchored at the ends by words that define the bounds of various pain dimensions. The patient is asked to place a vertical mark on the scale to indicate the level of intensity of his or her pain being 0 equivalent to no pain and 100 to the worst possible pain between Day 1 (first day) and Day 4, Day 1 corresponding to the first administered dose of the treatment (Gabapentin or Placebo). | Day 4 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of patients with at least one adverse event | Rate of patients with at least one adverse event (all types and grades) between Day 1 and Day 7: According to the National Cancer Institute Common terminology criteria for adverse events (NCI CTCAE) v4.0 | Day 7 | 
| Change in VAS for lumbalgia | Change in VAS between Day 1 and Day 4. | 72 hours | 
| Responder rate for lumbalgia at Day 4. | A responder is considered when VAS for low back pain is < 40/100 | Day 4 | 
| VAS for radiculalgia |  | Day 7 | 
| VAS for lumbalgia |  | Day 7 | 
| Neuropathic Pain Symptom Inventory (NPSI) scale | The presence of neuropathic pain will be evaluated by the Neuropathic Pain Symptom Inventory (NPSI) scale. This is a self-questionnaire.The tool evaluates mean pain intensity in the last 24h in a verbal numeric scale from zero (no pain) to 10 (worst imaginable pain). Total pain intensity score may be calculated by the sum of 10 descriptors.Evolution of the NPSI (Neuropathic Pain Symptom Inventory) between Day 1 and Day 4, then between Day 1 and Day 7 | Day 7 | 
| Dn4 (neuropathic pain screening questionnaire) | In the Dn4 questionnaire there are 4 questions with 10 items. Answers are yes or not. At the end of the questionnaire each no is considered as 0, each yes is considered as 1. The total score is 10. When addition of answers is 4 or more the test is considered as positive. | Day 7 | 
| Number of interdose of anti-nociceptive analgesics | Number of interdose of anti-nociceptive analgesics between Day 1 and Day 4. | Day 4 | 
| Rate of patients having used at least one interdose | Rate of patients having used at least one interdose between Day 1 and Day 4 | Day 4 | 
| Rate of patients having reduced the associated anti-nociceptive analgesic treatment | Rate of patients having reduced the associated anti-nociceptive analgesic treatment (decrease in dosage or step or stop) between Day 4 and and Day 7. | Day 7 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Radiculalgia, Lumbosacral spine, Disc herniation, Gabapentin