Short-term Effectiveness of Gabapentin Versus Placebo in Acute Lumbosacral Radiculalgia by Herniation Disc: a Prospective, Multicentric, Randomized, Controlled, Double-blind Study
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 144
- 试验地点
- 10
- 主要终点
- Change in Visual Analogical Scale (VAS) for radiculalgia
研究概览
简要总结
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.
详细描述
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).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Placebo
PLACEBO:
- DAY 1:300 mg
- DAY 2: 600 mg
- DAY 3: 900 mg
干预措施: PLACEBO (Drug)
Gabapentin
GABAPENTIN per os*:
- DAY 1:300 mg
- DAY 2: 600 mg
- DAY 3: 900 mg
干预措施: Gabapentin 300mg (Drug)
结局指标
主要结局
Change in Visual Analogical Scale (VAS) for radiculalgia
时间窗: Day 4
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).
次要结局
- VAS for radiculalgia(Day 7)
- Rate of patients with at least one adverse event(Day 7)
- Change in VAS for lumbalgia(72 hours)
- Responder rate for lumbalgia at Day 4.(Day 4)
- VAS for lumbalgia(Day 7)
- Rate of patients having used at least one interdose(Day 4)
- Neuropathic Pain Symptom Inventory (NPSI) scale(Day 7)
- Rate of patients having reduced the associated anti-nociceptive analgesic treatment(Day 7)
- Number of interdose of anti-nociceptive analgesics(Day 4)
- Dn4 (neuropathic pain screening questionnaire)(Day 7)