Lumbar RadiculopathyNCT07411326
Does Intraoperative Application of Steroids Affect Early Outcomes in Patients Undergoing Endoscopic Lumbar Discectomy?
A study testing Intervention Group in people with Lumbar Radiculopathy and Lumbar Herniated Disk, run by Centro Hospitalar De São João, E.P.E. at 1 site in Portugal.
Trial summary
Prospective randomised trial assessing whether intraoperative application of steroids leads to better clinical outcomes in patients submitted to lumbar discectomy Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Lumbar Radiculopathy, Lumbar Herniated Disk
- What is being tested?
- Intervention Group
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 sitePortugal
- Study dates
- 10 Sep 2022to 31 Jan 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Adult patients (≥18 years) Undergoing single-level full-endoscopic lumbar discectomy Symptomatic lumbar disc herniation Ability to provide written informed consent
Who cannot join
- Previous lumbar surgery at the same level Foraminal or extraforaminal disc herniations Multilevel surgery Intraoperative conversion to microdiscectomy Dural tear precluding epidural steroid application
Trial locations and contacts
1 site in 1 country.
Portugal1 site
Centro Hospitalar Universitario São João
Porto, Porto District, 4445
About this study
Official title: 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
Read the 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
- Conditions
- Lumbar Radiculopathy, Lumbar Herniated Disk
- Being tested
- Intervention Group, Control group (Normal Saline) (C)
- Keywords
- steroids, lumbar radiculopathy, back and leg pain, ODI, endoscopic surgery
- Medical subject headings
- Radiculopathy, Intervertebral Disc Displacement
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
patients given intraoperative dexamethasone after hernia removal
Control group (Normal Saline) (C)Other
patients given 2mL saline
| Study group | Role | What they receive |
|---|---|---|
| control group | Active comparator | Patients undergoing full-endoscopic lumbar discectomy receiving epidural saline. Receives: Other: Control group (Normal Saline) (C) |
| Dexamethasone group | Experimental | Patients undergoing full-endoscopic lumbar discectomy receiving epidural dexamethasone 8 mg. Receives: Drug: Intervention Group |
What is being measured
The primary outcome is the main question the study is designed to answer.
NRS back and NRS leg
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
Measured: 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 outcomes (1)
ODI
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.
Measured: patients will be evaluated over a 3 month period postoperatively, first at 1 month and then 3 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Feb 2026
- Study start10 Sep 2022
- Primary completion31 Jan 2025
- Study completion31 Jan 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lumbar RadiculopathyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centro Hospitalar De São João, E.P.E.
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Pedro Daniel Valente Aguiar, Centro Hospitalar De São João, E.P.E.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07411326
- Sponsor's protocol ID
- ULSSJOAO_80/23
- Status last verified
- Apr 2025
- First submitted
- 21 Apr 2025
- Last updated
- 13 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Does Intraoperative Application of Steroids Affect Early Outcomes in Patients Undergoing Endoscopic Lumbar Discectomy? - a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07411326
- Acronym / sponsor ID
- ULSSJOAO_80/23
- Conditions
- Lumbar Radiculopathy, Lumbar Herniated Disk
- Keywords
- steroids, lumbar radiculopathy, back and leg pain, ODI, endoscopic surgery
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Centro Hospitalar De São João, E.P.E.University, hospital or other
- Study start
- 10 Sep 2022 (actual)
- Primary completion
- 31 Jan 2025 (actual)
- Study completion
- 31 Jan 2025 (actual)
- First posted
- 13 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| control group | Active comparator | Other: Control group (Normal Saline) (C)Patients undergoing full-endoscopic lumbar discectomy receiving epidural saline. |
| Dexamethasone group | Experimental | Drug: Intervention GroupPatients undergoing full-endoscopic lumbar discectomy receiving epidural dexamethasone 8 mg. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Adult patients (≥18 years) Undergoing single-level full-endoscopic lumbar discectomy Symptomatic lumbar disc herniation Ability to provide written informed consent
Key exclusion criteria (1 listed)
- Previous lumbar surgery at the same level Foraminal or extraforaminal disc herniations Multilevel surgery Intraoperative conversion to microdiscectomy Dural tear precluding epidural steroid application
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Intervention Grouppatients given intraoperative dexamethasone after hernia removal | Drug | Dexamethasone group |
| Control group (Normal Saline) (C)patients given 2mL saline | Other | control group |
Primary outcome
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
1 secondary outcome
ODI
Time frame: patients will be evaluated over a 3 month period postoperatively, first at 1 month and then 3 months.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Feb 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intervention Group in people with Lumbar Radiculopathy and Lumbar Herniated Disk, run by Centro Hospitalar De São João, E.P.E. at 1 site in Portugal.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Portugal. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Feb 2026.