NCT04865042

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

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

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 144 (estimated)
• Sponsor: Lille Catholic University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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).

Conditions

• Radiculopathy of Lumbosacral Spine Due to Disc Disorder

Interventions

Type	Name	Description
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.
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.

Timeline

• Start date: 2022-02-02
• Primary completion: 2025-02-01
• Completion: 2025-02-01
• First posted: 2021-04-29
• Last updated: 2023-06-23

Locations

5 sites across 1 country: France