RecruitingPhase 4NCT07180940

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

Sponsor

Poznan University of Medical Sciences

Enrollment

150 participants

Start Date

Sep 1, 2025

Study Type

INTERVENTIONAL

Conditions

Spine Disease Spinal Diseases

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

Min Age: 18 Years

Inclusion Criteria6

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 Criteria10

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

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Interventions

DRUG0.9%NaCl

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

DRUGDexamethasone 4mg

2 x 20ml 0.2% ropivacaine with 2mg of dexamethasone

DRUGDexmedetomidine

2 x 20ml 0.2% ropivacaine with 25ug Dexmedetomidine

Locations(1)

Poznan University of Medical Sciences

Poznan, Poland

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NCT07180940

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