NCT02807194

Brief Summary

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

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
51

participants targeted

Target at P25-P50 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2014

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2015

Completed
1.5 years until next milestone

First Submitted

Initial submission to the registry

June 16, 2016

Completed
5 days until next milestone

First Posted

Study publicly available on registry

June 21, 2016

Completed
Last Updated

June 22, 2016

Status Verified

June 1, 2016

Enrollment Period

10 months

First QC Date

June 16, 2016

Last Update Submit

June 21, 2016

Conditions

Lumbar Disk Surgery

Outcome Measures

Primary Outcomes (1)

  • consumption of analgesic Level III (according to WHO criteria)

    24hours

Study Arms (2)

general anesthesia

EXPERIMENTAL

'lumbar disc herniation'

Other: general anesthesiaProcedure: lumbar disc herniation

spinal anesthesia

EXPERIMENTAL

'lumbar disc herniation'

Other: spinal anesthesiaProcedure: lumbar disc herniation

Interventions

spinal anesthesiaOTHER
spinal anesthesia
general anesthesiaOTHER
general anesthesia
lumbar disc herniationPROCEDURE
general anesthesiaspinal anesthesia

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • single lumbar disk herniation elective for surgery

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Chu Reims

France, Reims, 51092, France

Location

MeSH Terms

Interventions

Anesthesia, SpinalAnesthesia, General

Intervention Hierarchy (Ancestors)

Anesthesia, ConductionAnesthesiaAnesthesia and Analgesia

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 16, 2016

First Posted

June 21, 2016

Study Start

March 1, 2014

Primary Completion

January 1, 2015

Last Updated

June 22, 2016

Record last verified: 2016-06

Locations

FR(1)