CClinicalTrials.gg
CompletedNCT02807194Updated Jun 22, 2016

Ambulatory Lumbar Disk Surgery

An interventional study of spinal anesthesia and general anesthesia in Lumbar Disk Surgery, sponsored by CHU de Reims. Completed at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2016-06-22.

Sponsored by CHU de Reims · Not applicable, Interventional, and Supportive care

Phase
Not applicable
Study type
Interventional
Enrollment
51
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study summary

Primary Goal: To compare the clinical outcomes of spinal anesthesia and general anesthesia in surgery for lumbar disc herniation.

Read the detailed description

Patients included: All patients in the neurosurgery department of the University Hospital of Reims or in the neurosurgery department of CHG Chalons en Champagne for surgical management of lumbar disc herniation and agreeing to participate in the research. The types of anesthesia (general anesthesia or spinal anesthesia) will be randomized.

Investigation Plan: Participation in the research will be available to any eligible patient during the anesthesia consultation prior hospitalization for surgery. If the patient agrees to participate in research, randomization of the anesthetic technique will be realized. The anesthetist and the patient will be informed of the outcome of this randomization. Hospitalization of patients will not be changed. They will be hospitalized in inpatient, as usual, with an entry the day before surgery and an outlet the next day (without complications). The surgery itself will not be changed. The patient's postoperative monitoring will not be changed. Data will be collected for each patient: demographic data, medical data, data about the intervention and anesthesia, postoperative data management.

02

Conditions studied

  • Lumbar Disk Surgery
03

In context

Lead sponsor

CHU de Reims is the lead sponsor of 267 studies on the registry; 50 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • single lumbar disk herniation elective for surgery

Exclusion criteria

Exclusion Criteria:

  • Patients with haemostatic disorder
  • Patients with lumbar spine surgery history
  • Patients with sciatica called "hyperalgesia" resistant to treatment including systemic corticosteroids and 3 WHO bearing analgesics (oral morphine)
  • Patients with true paralyzing sciatica with motor disorders compatible with the path of the root compressed by the herniation
  • Patients with sphincter disorders
  • Patients with herniated disc multistage
  • Pregnant women
  • Patients with comorbid against-showing the elongated position, including cardiorespiratory comorbidities
  • Minors patients
  • Patients protected by law.
05

Study design

Phase
Not applicable
Primary purpose
Supportive care
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
51 participants (actual)

Study arms

  • Experimental
    general anesthesia

    'lumbar disc herniation'

    Other: general anesthesia · Procedure: lumbar disc herniation

  • Experimental
    spinal anesthesia

    'lumbar disc herniation'

    Other: spinal anesthesia · Procedure: lumbar disc herniation

Interventions

  • Otherspinal anesthesia
  • Othergeneral anesthesia
  • Procedurelumbar disc herniation
06

What researchers measure

Primary outcomes

  1. consumption of analgesic Level III (according to WHO criteria)

    Time frame: 24hours

07

Study locations

1 site
  • Chu Reims
    France, Reims 51092, France
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 22, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT02807194
Lead sponsor
CHU de Reims
Responsible party
Sponsor
First posted
Jun 21, 2016
Start date
Mar 2014
Primary completion
Jan 2015
Last update
Jun 22, 2016
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Jun 2016. You cannot join it, but the record below documents what was studied.

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