Ambulatory Lumbar Disk Surgery

Lumbar Disk Surgery Clinical Trial

Official title:

Epidural Anesthesia Versus General Anesthesia for Elective Lumbar Disk Surgery in a Outpatient Basis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02807194
• Other study ID #: PO13123
• Status: Completed
• Phase: N/A
• First received: June 16, 2016
• Last updated: June 21, 2016
• Start date: March 2014

Study information

• Verified date: June 2016
• Source: CHU de Reims
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Agence Nationale de Sécurité du Médicament et des produits de santé
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 51
• Est. primary completion date: January 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Lumbar Disk Surgery

Intervention

Other:
• spinal anesthesia

• general anesthesia

Procedure:
• lumbar disc herniation

Locations

Country	Name	City	State
France	Chu Reims	France	Reims

Sponsors (1)

Lead Sponsor	Collaborator
CHU de Reims

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	consumption of analgesic Level III (according to WHO criteria)		24hours	No