Comparison of Perineural Dexamethasone Versus Dexmedetomidine as Adjuvants to Erector Spinae Plane Block in Lumbar Spine Surgery: A Randomized, Double-blind, Controlled Trial
1 other identifier
interventional
150
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_4
Started Sep 2025
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2025
CompletedFirst Submitted
Initial submission to the registry
September 12, 2025
CompletedFirst Posted
Study publicly available on registry
September 18, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 30, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 31, 2026
September 18, 2025
September 1, 2025
1.1 years
September 12, 2025
September 12, 2025
Conditions
Outcome Measures
Primary Outcomes (1)
Total opioid Consuption
Cumulative opioid consumption during the first 24 and 48 hours after surgery, converted to morphine milligram equivalents (MME)
48 hours after surgery
Secondary Outcomes (19)
NRS
4 hours after surgery
NRS
8 hours after surgery
NRS
12 hours after surgery
NRS
24 hours after surgery
NRS
48 hours after surgery
- +14 more secondary outcomes
Study Arms (3)
Control group
PLACEBO COMPARATORBilateral ESPB (2 x 20ml 0.2% ropivacaine with 1ml 0.9% NaCl)
Dexamethasone group
EXPERIMENTALBilateral ESPB (2 x 20ml 0.2% ropivacaine with 2mg dexamethasone)
Dexmedetomidine group
EXPERIMENTALBilateral ESPB (2 x 20ml 0.2% ropivacaine with 25ug dexmedetomidine)
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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 the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Poznan University of Medical Sciences
Poznan, 62-701, Poland
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 12, 2025
First Posted
September 18, 2025
Study Start
September 1, 2025
Primary Completion (Estimated)
September 30, 2026
Study Completion (Estimated)
December 31, 2026
Last Updated
September 18, 2025
Record last verified: 2025-09
Data Sharing
- IPD Sharing
- Will share