Ambulatory Lumbar Disk Surgery

June 21, 2016 updated by: CHU de Reims

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

51

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
    • Reims
      • France, Reims, France, 51092
        • Chu Reims

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: general anesthesia
'lumbar disc herniation'
Other: general anesthesia
Procedure: lumbar disc herniation
Experimental: spinal anesthesia
'lumbar disc herniation'
Procedure: lumbar disc herniation
Other: spinal anesthesia

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
consumption of analgesic Level III (according to WHO criteria)
Time Frame: 24hours
24hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

CHU de Reims

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2014

Primary Completion (Actual)

January 1, 2015

Study Registration Dates

First Submitted

June 16, 2016

First Submitted That Met QC Criteria

June 20, 2016

First Posted (Estimate)

June 21, 2016

Study Record Updates

Last Update Posted (Estimate)

June 22, 2016

Last Update Submitted That Met QC Criteria

June 21, 2016

Last Verified

June 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PO13123

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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