Lumbar Disk SurgeryNCT02807194
Ambulatory Lumbar Disk Surgery
A study testing spinal anesthesia, general anesthesia and lumbar disc herniation in people with Lumbar Disk Surgery, run by CHU de Reims at 1 site in France.
Trial summary
Primary Goal: To compare the clinical outcomes of spinal anesthesia and general anesthesia in surgery for lumbar disc herniation. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lumbar Disk Surgery
- What is being tested?
- spinal anesthesia, general anesthesia and lumbar disc herniation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 51 participants
- Where
- 1 siteFrance
- Study dates
- Mar 2014to Jan 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- single lumbar disk herniation elective for surgery
Who cannot join
- 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
Show all 10Show fewer
- Pregnant women
- Patients with comorbid against-showing the elongated position, including cardiorespiratory comorbidities
- Minors patients
- Patients protected by law.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Lumbar Disk Surgery
- Being tested
- spinal anesthesia, general anesthesia, lumbar disc herniation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
spinal anesthesiaOther
general anesthesiaOther
lumbar disc herniationProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| general anesthesia | Experimental | 'lumbar disc herniation' Receives: Other: general anesthesia; Procedure: lumbar disc herniation |
| spinal anesthesia | Experimental | 'lumbar disc herniation' Receives: Other: spinal anesthesia; Procedure: lumbar disc herniation |
What is being measured
The primary outcome is the main question the study is designed to answer.
consumption of analgesic Level III (according to WHO criteria)
Measured: 24hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jun 2016 (estimated)
- Study startMar 2014
- Primary completionJan 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lumbar Disk SurgeryStudies of the same condition, open and under way.
- More trials run by CHU de ReimsThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 51 participants (actual)
Sponsor and investigators
- Lead sponsor
- CHU de Reims
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02807194
- Sponsor's protocol ID
- PO13123
- Status last verified
- Jun 2016
- First submitted
- 16 Jun 2016
- Last updated
- 22 Jun 2016
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jun 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Epidural Anesthesia Versus General Anesthesia for Elective Lumbar Disk Surgery in a Outpatient Basis
- ClinicalTrials.gov ID
- NCT02807194
- Acronym / sponsor ID
- PO13123
- Conditions
- Lumbar Disk Surgery
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 51 participants (actual)
- Lead sponsor
- CHU de ReimsUniversity, hospital or other
- Study start
- Mar 2014
- Primary completion
- Jan 2015 (actual)
- First posted
- 21 Jun 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| general anesthesia | Experimental | Other: general anesthesia, Procedure: lumbar disc herniation'lumbar disc herniation' |
| spinal anesthesia | Experimental | Other: spinal anesthesia, Procedure: lumbar disc herniation'lumbar disc herniation' |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- single lumbar disk herniation elective for surgery
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| spinal anesthesia | Other | spinal anesthesia |
| general anesthesia | Other | general anesthesia |
| lumbar disc herniation | Procedure or surgery | general anesthesia, spinal anesthesia |
Primary outcome
consumption of analgesic Level III (according to WHO criteria)
Time frame: 24hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jun 2016.
Related trials for Lumbar Disk Surgery
Not yet recruiting
Selective Nerve Root Block Versus Sham to Reduce Surgery for Lumbar Disc Herniation
Lumbar Disc Herniation, Lumbar Radiculopathy
RecruitingObservational study
Pulmonary Mechanics and Cerebral Oxygenation During Prone Lumbar Disc Surgery
Lumbar Disc Herniation, Respiratory Mechanics
Recruiting
More Realistic Spine Patients: Assessing the Effect of Dialogue Support Tool.
Spinal Stenosis Lumbar, Disc Herniation, Lumbar
Recruiting
Effect of Irrigation Pressure on Postoperative Complications and Surgical Field Clarity in Unilateral Biportal Endoscopic Surgery
Lumbar Disc Herniation, Lumbar Spinal Stenosis
Recruiting
Postoperative Pain and Analgesic Use Following Lumbar Discectomy: A Comparative Study of Endoscopic Surgery and Open Surgery
Herniated Lumbar Disc
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing spinal anesthesia, general anesthesia and lumbar disc herniation in people with Lumbar Disk Surgery, run by CHU de Reims at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Jun 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
consumption of analgesic Level III (according to WHO criteria) (time frame: 24hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jun 2016.