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Does Intraoperative Application of Steroids Affect Early Outcomes in Patients Undergoing Endoscopic Lumbar Discectomy?

Does Intraoperative Application of Steroids Affect Early Outcomes in Patients Undergoing Endoscopic Lumbar Discectomy? - a Randomized Controlled Trial

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07411326
Enrollment
90
Registered
2026-02-13
Start date
2022-09-10
Completion date
2025-01-31
Last updated
2026-02-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Lumbar Herniated Disk, Lumbar Radiculopathy

Keywords

steroids, lumbar radiculopathy, back and leg pain, ODI, endoscopic surgery

Brief summary

Prospective randomised trial assessing whether intraoperative application of steroids leads to better clinical outcomes in patients submitted to lumbar discectomy

Detailed description

Prospective randomised trial assessing whether intraoperative application of steroids leads to better clinical outcomes in patients submitted to lumbar discectomy A control group has hernia removal without preoperative application of dexamethasone whilst 2 mL of dexamethasone is applied to the intervention group after hernia removal The investigators evaluated outcomes through back and leg NRS 48h, 2 weeks, 1 month and 3 months after surgery and ODI at 1 and 3 months post op

Interventions

DRUGIntervention Group

patients given intraoperative dexamethasone after hernia removal

patients given 2mL saline

Sponsors

Centro Hospitalar De São João, E.P.E.
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

Inclusion criteria

Adult patients (≥18 years) Undergoing single-level full-endoscopic lumbar discectomy Symptomatic lumbar disc herniation Ability to provide written informed consent

Exclusion criteria

Previous lumbar surgery at the same level Foraminal or extraforaminal disc herniations Multilevel surgery Intraoperative conversion to microdiscectomy Dural tear precluding epidural steroid application

Design outcomes

Primary

MeasureTime frameDescription
NRS back and NRS legpatients will be evaluated over a 3 month period postoperatively, first at 48 hours post surgery, then 2 weeks and 1 month after surgery.back and leg pain measured by a numerical rating scale. the NRS is a 0 to 10 scale in which 10 means the highest pain score

Secondary

MeasureTime frameDescription
ODIpatients will be evaluated over a 3 month period postoperatively, first at 1 month and then 3 months.Oswestry disability index. he ODI is a 0 to 100 scale in which 100 represents the highest level of disability and 0 the lowest level of disability.

Countries

Portugal

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 14, 2026