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

Sponsor

Lille Catholic University (Other)

Overall Status

Recruiting

CT.gov ID

NCT04865042

Collaborator

(none)

144

Enrollment

Locations

Arms

Anticipated Duration (Months)

Patients Per Site

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Radiculopathy of Lumbosacral Spine Due to Disc Disorder	Drug: Gabapentin 300mg Drug: PLACEBO	Phase 4

Study Design

Study Type:

Interventional

Anticipated Enrollment :

144 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Triple (Participant, Care Provider, Investigator)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Feb 2, 2022

Anticipated Primary Completion Date :

Feb 1, 2025

Anticipated Study Completion Date :

Feb 1, 2025

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Gabapentin	Drug: Gabapentin 300mg 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.
Placebo Comparator: Placebo	Drug: PLACEBO 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.

Arm

Intervention/Treatment

Experimental: Gabapentin

Drug: Gabapentin 300mg

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.

Placebo Comparator: Placebo

Drug: PLACEBO

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.

Outcome Measures

Primary Outcome Measures

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

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) v4.0
Change 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 radiculalgia [Day 7]
VAS for lumbalgia [Day 7]
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
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.
Number of interdoses of anti-nociceptive analgesics [Day 4]
Number of interdoses of anti-nociceptive analgesics between Day 1 and Day 4.
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
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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts 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),
History of pre-existing 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