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.
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).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
144
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.
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.
CH Arras-rheumatology
Arras, France
RECRUITINGCH Béthune-rheumatology
Béthune, France
RECRUITINGCHU Caen-rheumatology
Caen, France
RECRUITINGChange 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).
Time frame: Day 4
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
Time frame: Day 7
Change in VAS for lumbalgia
Change in VAS between Day 1 and Day 4.
Time frame: 72 hours
Responder rate for lumbalgia at Day 4.
A responder is considered when VAS for low back pain is \< 40/100
Time frame: Day 4
VAS for radiculalgia
Time frame: Day 7
VAS for lumbalgia
Time frame: 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
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CH Dunkerque-rheumatology
Dunkirk, France
RECRUITINGCHU Rouen-rheumatology
Rouen, France
RECRUITINGTime frame: 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.
Time frame: Day 7
Number of interdose of anti-nociceptive analgesics
Number of interdose of anti-nociceptive analgesics between Day 1 and Day 4.
Time frame: 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
Time frame: 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.
Time frame: Day 7