Perioperative Outcome of Corticosteroids in Transforamina... | NCT03273036

Studies
Perioperative Outcome of Corticosteroids in Transforaminal Endoscopic Lumbar Discectomy

NCT03273036

Sponsor

Ramathibodi Hospital

Status

Completed

Last Update Posted

Sep 6, 2017Actual

Enrollment

30Actual

Phase

Phase 4

Conditions

Lumbar Disc Herniation

Interventions

40 mg Triamcinolone acetate 1 cc
Placebos

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Sep 2017

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 1, 2014Actual

Primary Completion Date

May 1, 2015Actual

Completion Date

May 1, 2015Actual

First Submitted Date

Aug 29, 2017

First Submission Date that Met QC Criteria

Sep 1, 2017

First Posted Date

Sep 6, 2017Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 1, 2017

Last Update Posted Date

Sep 6, 2017Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The endoscopic discectomy has rapidly developed and increased need by patients. This procedure is widely performed by interventional pain physicians as well as by spine surgeons because it requires no general anesthesia or admission to a hospital. Many studies were reported that corticosteroid injection can inhibit persistent postoperative pain in lumbar discectomy. However, data of perioperative epidural steroids after an endoscopic discectomy is lacking.

Detailed Description

To examine whether corticosteroid administered epidural space in patients undergoing endoscopic lumbar discectomy reduces postoperative morphine consumption, back and leg pain relief, improves functional disability comparing to placebo

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

30Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
epidural steroid injection	Active Comparator	40 mg triamcinolone acetate 1 cc	Drug: 40 mg Triamcinolone acetate 1 cc
placebo injection	Placebo Comparator	no injection agent	Drug: Placebos

Interventions

Name	Type	Description	Arm Group Labels	Other Names
40 mg Triamcinolone acetate 1 cc	Drug	40 mg Triamcinolone acetate 1 cc	epidural steroid injection

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Post-operative morphine consumption		Post operative 24 hour of morphine consumption in mg

Secondary Outcomes

Measure	Description	Time Frame
Visual analog score (back and leg) 0-10		1 day, 2, 6 ,12, 24 weeks
Oswestry disability index (ODI		2, 6 ,12, 24 weeks
MacNab scores

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Lumbar disc herniation patient age 20-45 year-old who have symptom duration was at least 6 weeks and conservative treatment failed

Exclusion Criteria:

Refuse to participate and inform consent, Previous spinal surgery, History of allergic to steroid

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

20 Years

Maximum Age

45 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D007405	Intervertebral Disc Displacement

Ancestor Terms

ID	Term
D013122	Spinal Diseases
D001847	Bone Diseases
D009140	Musculoskeletal Diseases
D006547	Hernia

Browse Leaves

Not provided

Browse Branches

Not provided