NCT07180940 Comparison of Perineural Dexamethasone Versus Dexmedetomidine as Adjuvants to Erector Spinae Plane Block in Lumbar Spine Surgery: A Randomized, Double-blind, Controlled Trial
| NCT ID | NCT07180940 |
| Status | Recruiting |
| Phase | Phase 4 |
| Sponsor | Poznan University of Medical Sciences |
| Condition | Spine Disease |
| Study Type | INTERVENTIONAL |
| Enrollment | 150 participants |
| Start Date | 2025-09-01 |
| Primary Completion | 2026-09-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 4 studies follow an already-approved treatment in real-world conditions to monitor long-term safety and effectiveness.
This trial targets 150 participants in total. It began in 2025-09-01 with a primary completion date of 2026-09-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
This clinical study aims to determine which of two medications-dexamethasone or dexmedetomidine-works better and is safer when used together with a local anesthetic (ropivacaine) in a type of nerve block called the erector spinae plane block (ESPB). This block helps reduce pain after lumbar spine surgery.
Eligibility Criteria
Inclusion Criteria: * Adults aged 18 to N/A (no limit) * Scheduled for elective lumbar spine surgery (e.g., decompression or fusion) via posterior approach * American Society of Anesthesiologists (ASA) physical status I-III * Body weight ≥ 50 kg * Ability to provide written informed consent * Expected postoperative hospitalization of at least 48 hours Exclusion Criteria: * Known allergy or contraindication to ropivacaine, dexamethasone, or dexmedetomidine * Infection at or near the site of block placement * Coagulation disorders or current use of anticoagulant therapy (not discontinued per guidelines) * Chronic opioid use or opioid dependence * Neurological or psychiatric disorders interfering with pain assessment * Diabetes mellitus with poorly controlled glycemia (e.g., HbA1c \> 8%) * Severe hepatic or renal dysfunction * Body mass index (BMI) \> 40 kg/m² * Pregnancy or breastfeeding * Refusal or inability to cooperate with the study protocol
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07180940 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Spine Disease. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07180940 trial and what does that mean for participants?
Phase 4 studies are conducted after a treatment has been approved. They monitor long-term safety and real-world effectiveness in a broader patient population.
Is NCT07180940 currently recruiting?
Yes, NCT07180940 is actively recruiting participants. Contact the research team at mreysner@ump.edu.pl for enrollment information.
Where is the NCT07180940 trial being conducted?
This trial is being conducted at Poznan, Poland.
Who is sponsoring the NCT07180940 clinical trial?
NCT07180940 is sponsored by Poznan University of Medical Sciences. The trial plans to enroll 150 participants.