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Completed

NCT Number: NCT07411326

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

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

Completed

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Centro Hospitalar Universitario São João

Porto, Porto District, 4445, Portugal

About this study

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Intervention Group

Drug

patients given intraoperative dexamethasone after hernia removal

Control group (Normal Saline) (C)

Other

patients given 2mL saline

Primary outcomes

  1. NRS back and NRS leg

    Time frame: patients 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 outcomes

  1. ODI

    Time frame: patients 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.

Sponsors and collaborators

Lead sponsor

Centro Hospitalar De São João, E.P.E.

Other

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2025
Study completion
2025
First posted
Feb 13, 2026
Registry last updated
Feb 13, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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