Ambulatory Lumbar Disk Surgery

Not Applicable

Completed

• Conditions: Lumbar Disk Surgery
• Interventions: Other: spinal anesthesia; Other: general anesthesia; Procedure: lumbar disc herniation

• Registration Number: NCT02807194
• Lead Sponsor: CHU de Reims

Brief Summary

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

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.

Study Timeline

• Study Start: 2014-03
• Primary Completion: 2015-01
• Status Verified: 2016-06
• Study First Submitted: 2016-06-16
• Study First Submitted QC: 2016-06-20
• Study First Posted: 2016-06-21
• Last Update Submitted: 2016-06-21
• Last Update Posted: 2016-06-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 51

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
spinal anesthesia	spinal anesthesia	'lumbar disc herniation'
general anesthesia	general anesthesia	'lumbar disc herniation'
general anesthesia	lumbar disc herniation	'lumbar disc herniation'
spinal anesthesia	lumbar disc herniation	'lumbar disc herniation'

Primary Outcome Measures

Name	Time	Method
consumption of analgesic Level III (according to WHO criteria)	24hours

Trial Locations

Locations (1)

Chu Reims; 🇫🇷 France, Reims, France