Status:
RECRUITING
Comparison of Perineural Dexamethasone Versus Dexmedetomidine as Adjuvants to Erector Spinae Plane Block in Lumbar Spine Surgery: A Randomized, Double-blind, Controlled Trial
Lead Sponsor:
Poznan University of Medical Sciences
Conditions:
Spine Disease
Spinal Diseases
Eligibility:
All Genders
18+ years
Phase:
PHASE4
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 bl...
Detailed Description
All participants will receive general anesthesia for surgery and, in addition, a nerve block on both sides of the lower back. The nerve block will be done with ultrasound guidance and will include rop...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
September 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2026
Estimated Enrollment :
150 Patients enrolled
Trial Details
Trial ID
NCT07180940
Start Date
September 1 2025
End Date
December 31 2026
Last Update
September 18 2025
Active Locations (1)
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1
Poznan University of Medical Sciences
Poznan, Poland, 62-701