Short-term Effectiveness of Gabapentin Versus Placebo in Acute Lumbosacral Radiculalgia by Herniation Disc (GRADE)
- Conditions
- Radiculopathy of Lumbosacral Spine Due to Disc Disorder
- Interventions
- Drug: PLACEBO
- Registration Number
- NCT04865042
- Lead Sponsor
- Lille Catholic University
- 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).
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 144
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Placebo PLACEBO PLACEBO: * DAY 1:300 mg * DAY 2: 600 mg * DAY 3: 900 mg Gabapentin Gabapentin 300mg GABAPENTIN per os\*: * DAY 1:300 mg * DAY 2: 600 mg * DAY 3: 900 mg
- Primary Outcome Measures
Name Time Method Change in Visual Analogical Scale (VAS) for radiculalgia 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).
- Secondary Outcome Measures
Name Time Method VAS for radiculalgia Day 7 Rate of patients with at least one adverse event Day 7 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) v4.0Change in VAS for lumbalgia 72 hours Change in VAS between Day 1 and Day 4.
Responder rate for lumbalgia at Day 4. Day 4 A responder is considered when VAS for low back pain is \< 40/100
VAS for lumbalgia Day 7 Rate of patients having used at least one interdose Day 4 Rate of patients having used at least one interdose between Day 1 and Day 4
Neuropathic Pain Symptom Inventory (NPSI) scale Day 7 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
Rate of patients having reduced the associated anti-nociceptive analgesic treatment Day 7 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.
Number of interdose of anti-nociceptive analgesics Day 4 Number of interdose of anti-nociceptive analgesics between Day 1 and Day 4.
Dn4 (neuropathic pain screening questionnaire) Day 7 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.
Trial Locations
- Locations (5)
CH Arras-rheumatology
🇫🇷Arras, France
CH Dunkerque-rheumatology
🇫🇷Dunkerque, France
CHU Caen-rheumatology
🇫🇷Caen, France
CHU Rouen-rheumatology
🇫🇷Rouen, France
CH Béthune-rheumatology
🇫🇷Béthune, France