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

NCT07411326 | Completed

• 1 other identifier: ULSSJOAO_80/23
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Lumbar Radiculopathy; Lumbar Herniated Disk

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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

  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

  patients will be evaluated over a 3 month period postoperatively, first at 1 month and then 3 months.

Study Arms (2)

control group

ACTIVE COMPARATOR

Patients undergoing full-endoscopic lumbar discectomy receiving epidural saline.

Other: Control group (Normal Saline) (C)

Dexamethasone group

EXPERIMENTAL

Patients undergoing full-endoscopic lumbar discectomy receiving epidural dexamethasone 8 mg.

Drug: Intervention Group

Interventions

Intervention Group DRUG

patients given intraoperative dexamethasone after hernia removal

Dexamethasone group

Control group (Normal Saline) (C) OTHER

patients given 2mL saline

control group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Centro Hospitalar De São João, E.P.E.: lead

Study Sites (1)

Centro Hospitalar Universitario São João

Porto, Porto District, 4445, Portugal

Location

MeSH Terms

Conditions

Radiculopathy; Intervertebral Disc Displacement

Interventions

Control Groups; Saline Solution

Condition Hierarchy (Ancestors)

Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases; Spinal Diseases; Bone Diseases; Musculoskeletal Diseases; Hernia; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods; Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: April 21, 2025
• First Posted: February 13, 2026
• Study Start: September 10, 2022
• Primary Completion: January 31, 2025
• Study Completion: January 31, 2025
• Last Updated: February 13, 2026

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

PT (1)