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

Launched by LILLE CATHOLIC UNIVERSITY · Apr 27, 2021

Keywords

ClinConnect Summary

This clinical trial, called GRADE, is studying the effectiveness of a medication called Gabapentin in reducing pain for patients experiencing acute lumbosacral radiculalgia, which is pain caused by a herniated disc in the lower back. The trial will compare how well Gabapentin works compared to a placebo (a treatment that looks like the medication but has no active ingredients) over a short period of 72 hours. Participants will receive either Gabapentin or the placebo in addition to their regular pain treatment. Researchers will assess how much pain patients feel and how well they tolerate the treatment during this time.

To be eligible for the trial, participants must be at least 18 years old and have experienced moderate to severe leg pain for less than three months due to a herniated disc. They should also be admitted to the hospital for at least 72 hours. It's important that patients are not currently taking Gabapentin or similar medications and do not have certain health conditions that could complicate treatment. Participants will need to provide informed consent and may need to follow specific guidelines, especially women of childbearing age regarding contraception. Overall, this trial aims to find out if Gabapentin can effectively help manage pain in this specific group of patients.

Gender

ALL

Eligibility criteria

• 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