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

NCT04865042 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 144

Last updated 2026-04-21

No results posted yet for this study

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.

Conditions

  • Radiculopathy of Lumbosacral Spine Due to Disc Disorder

Interventions

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.

Sponsors & Collaborators

  • Lille Catholic University

    lead OTHER

Principal Investigators

  • Vincent Ducoulombier, MD · GHICL

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-02-02
Primary Completion
2024-12-05
Completion
2024-12-09

Countries

  • France

Study Locations

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Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04865042 on ClinicalTrials.gov