Ambulatory Lumbar Disk Surgery

NCT ID: NCT02807194

Last Updated: 2016-06-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

51 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-03-31

Brief Summary

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

Detailed Description

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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.

Conditions

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Lumbar Disk Surgery

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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general anesthesia

'lumbar disc herniation'

Group Type EXPERIMENTAL

general anesthesia

Intervention Type OTHER

lumbar disc herniation

Intervention Type PROCEDURE

spinal anesthesia

'lumbar disc herniation'

Group Type EXPERIMENTAL

spinal anesthesia

Intervention Type OTHER

lumbar disc herniation

Intervention Type PROCEDURE

Interventions

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spinal anesthesia

Intervention Type OTHER

general anesthesia

Intervention Type OTHER

lumbar disc herniation

Intervention Type PROCEDURE

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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CHU de Reims

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Chu Reims

France, Reims, France

Site Status

Countries

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France

Other Identifiers

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PO13123

Identifier Type: -

Identifier Source: org_study_id

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