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Clinical Trials in Poland / NCT07180940
Recruiting Phase 4

Comparison of Perineural Dexamethasone Versus Dexmedetomidine as Adjuvants to Erector Spinae Plane Block in Lumbar Spine Surgery: A Randomized, Double-blind, Controlled Trial

NCT07180940 · tracked via the Priya Life Science Poland tracker
Sponsor
Poznan University of Medical Sciences
Phase
Phase 4
Started
2025-09-01
Last updated
2025-09-18

Condition(s) studied

Spine DiseaseSpinal Diseases

Investigational drug(s) / intervention(s)

0.9%NaCl →Dexamethasone 4mg →Dexmedetomidine →

0.9%NaCl: 2 x 20ml 0.2% ropivacaine with 2ml of 0.9% NaCl

Dexamethasone 4mg: 2 x 20ml 0.2% ropivacaine with 2mg of dexamethasone

Dexmedetomidine: 2 x 20ml 0.2% ropivacaine with 25ug Dexmedetomidine

Study 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

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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

Primary outcome measure(s)

  • Total opioid Consuption — 48 hours after surgery
    Cumulative opioid consumption during the first 24 and 48 hours after surgery, converted to morphine milligram equivalents (MME)

Trial sites (1)

FacilityCityRegionStatus
Poznan University of Medical Sciences Poznan Poland Recruiting

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Other trials for the same condition

Lumbar Paravertebral Block vs Erector Spinae Plane Block in Elderly Patients Undergoing Lumbar Spine Surgery Starting soon
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07180940 on ClinicalTrials.gov ↗ ← All trials in Poland