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Ambulatory Lumbar Disk Surgery

C

CHU de Reims

Status

Completed

Conditions

Lumbar Disk Surgery

Treatments

Other: general anesthesia
Procedure: lumbar disc herniation
Other: spinal anesthesia

Study type

Interventional

Funder types

Other

Identifiers

NCT02807194
PO13123

Details and patient eligibility

About

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

Full 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.

Enrollment

51 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • single lumbar disk herniation elective for surgery

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.

Trial design

Primary purpose

Supportive Care

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

51 participants in 2 patient groups

general anesthesia
Experimental group
Description:
'lumbar disc herniation'
Treatment:
Procedure: lumbar disc herniation
Other: general anesthesia
spinal anesthesia
Experimental group
Description:
'lumbar disc herniation'
Treatment:
Procedure: lumbar disc herniation
Other: spinal anesthesia

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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