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CompletedNCT03273036Updated Sep 6, 2017

Perioperative Outcome of Corticosteroids in Transforaminal Endoscopic Lumbar Discectomy

A Phase 4 interventional study of 40 mg Triamcinolone acetate 1 cc and Placebos in Lumbar Disc Herniation, sponsored by Ramathibodi Hospital. Completed. Open to participants aged 20 Years to 45 Years. Per ClinicalTrials.gov, last updated 2017-09-06.

Sponsored by Ramathibodi Hospital · Phase 4, Interventional, and Treatment

Phase
Phase 4
Study type
Interventional
Enrollment
30
Allocation
Randomized
Ages
20 Years to 45 Years
Sex
All
01

Study 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.

Read the 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

02

Conditions studied

  • Lumbar Disc Herniation
03

Who can participate

Ages eligible
20 Years to 45 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

Exclusion Criteria:

  • Refuse to participate and inform consent, Previous spinal surgery, History of allergic to steroid
04

Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Participant, Investigator, Outcomes assessor)
Enrollment
30 participants (actual)

Study arms

  • Active comparator
    epidural steroid injection

    40 mg triamcinolone acetate 1 cc

    Drug: 40 mg Triamcinolone acetate 1 cc

  • Placebo comparator
    placebo injection

    no injection agent

    Drug: Placebos

Interventions

  • Drug40 mg Triamcinolone acetate 1 cc

    40 mg Triamcinolone acetate 1 cc

  • DrugPlacebos

    no injected agent

05

What researchers measure

Primary outcomes

  1. Post-operative morphine consumption

    Time frame: Post operative 24 hour of morphine consumption in mg

Secondary outcomes

  1. Visual analog score (back and leg) 0-10

    Time frame: 1 day, 2, 6 ,12, 24 weeks

  2. Oswestry disability index (ODI

    Time frame: 2, 6 ,12, 24 weeks

  3. MacNab scores

    Time frame: 2, 6 ,12, 24 weeks

06

Study locations

No study locations are listed for this record.

07

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT03273036
Lead sponsor
Ramathibodi Hospital
Responsible party
Jatupon Kongtharvonskul (principle investigator, Ramathibodi Hospital) — Principal investigator
First posted
Sep 6, 2017
Start date
May 1, 2014
Primary completion
May 1, 2015
Completion
May 1, 2015
Last update
Sep 6, 2017

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Sep 2017. You cannot join it, but the record below documents what was studied.

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