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

February 11, 2026 updated by: Pedro Daniel Valente Aguiar, Centro Hospitalar De São João, E.P.E.

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Study Type

Interventional

Enrollment (Actual)

90

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Portugal
    • Porto District
      • Porto, Porto District, Portugal, 4445
        • Centro Hospitalar Universitário São João

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: control group
Patients undergoing full-endoscopic lumbar discectomy receiving epidural saline.
Other: Control group (Normal Saline) (C)
patients given 2mL saline
Experimental: Dexamethasone group
Patients undergoing full-endoscopic lumbar discectomy receiving epidural dexamethasone 8 mg.
Drug: Intervention Group
patients given intraoperative dexamethasone after hernia removal

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
patients will be evaluated over a 3 month period postoperatively, first at 48 hours post surgery, then 2 weeks and 1 month after surgery.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
patients will be evaluated over a 3 month period postoperatively, first at 1 month and then 3 months.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centro Hospitalar De São João, E.P.E.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 10, 2022

Primary Completion (Actual)

January 31, 2025

Study Completion (Actual)

January 31, 2025

Study Registration Dates

First Submitted

April 21, 2025

First Submitted That Met QC Criteria

February 11, 2026

First Posted (Actual)

February 13, 2026

Study Record Updates

Last Update Posted (Actual)

February 13, 2026

Last Update Submitted That Met QC Criteria

February 11, 2026

Last Verified

April 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ULSSJOAO_80/23

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Lumbar Radiculopathy

Clinical Trials on Control group (Normal Saline) (C)

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Moldova

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe