Actively Recruiting
Comparison of Perineural Dexamethasone Versus Dexmedetomidine as Adjuvants to Erector Spinae Plane Block in Lumbar Spine Surgery: A Randomized, Double-blind, Controlled Trial
Led by Poznan University of Medical Sciences · Updated on 2025-09-18
150
Participants Needed
1
Research Sites
13 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating which medication, dexamethasone or dexmedetomidine, works better and is safer when added to a local anesthetic called ropivacaine in a nerve block named the erector spinae plane block (ESPB). This nerve block helps reduce pain after lumbar spine surgery. This phase 4, randomized, double-blind trial aims to improve pain management while reducing opioid use and their side effects after spine surgery. All participants will undergo general anesthesia for lumbar spine surgery and receive a bilateral ESPB using ultrasound guidance. The nerve block will include ropivacaine combined with either dexamethasone, dexmedetomidine, or a placebo (saline). Participants are randomly assigned to one of these three groups, and neither patients nor pain assessors will know which medication was used. During the study, researchers will monitor opioid use during the first 24 and 48 hours after surgery as the main outcome. They will also assess pain intensity at multiple time points, time to first pain relief, any nerve injuries, side effects such as nausea or low blood pressure, and laboratory markers like blood glucose and inflammation ratios. Participants are expected to stay in the hospital for at least 48 hours for monitoring and assessments.
CONDITIONS
Brief Title
Comparison of Perineural Dexamethasone Versus Dexmedetomidine as Adjuvants to Erector Spinae Plane Block in Lumbar Spine Surgery: A Randomized, Double-blind, Controlled Trial
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults aged 18 years or older
- Scheduled for elective lumbar spine surgery via posterior approach
- American Society of Anesthesiologists (ASA) physical status I to III
- Body weight at least 50 kilograms
- Ability to provide written informed consent
- Expected postoperative hospital stay of at least 48 hours
You will not qualify if you...
- Known allergy or contraindication to ropivacaine, dexamethasone, or dexmedetomidine
- Infection at or near the site of nerve block
- Coagulation disorders or ongoing anticoagulant therapy not stopped as per guidelines
- Chronic opioid use or opioid dependence
- Neurological or psychiatric disorders affecting pain assessment
- Poorly controlled diabetes (e.g., HbA1c over 8%)
- Severe liver or kidney dysfunction
- Body mass index (BMI) over 40 kg/m2
- Pregnancy or breastfeeding
- Refusal or inability to cooperate with study procedures
AI-Screening
AI-Powered Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Day of surgery
Participants receive general anesthesia for lumbar spine surgery along with a bilateral erector spinae plane nerve block with ropivacaine plus either dexamethasone or dexmedetomidine. The nerve block is given under ultrasound guidance during surgery.
1 surgical procedure visit (in-person)
Duration - 48 hours after surgery
Participants are monitored for pain levels, opioid use, side effects, and any complications related to the nerve block during the first 48 hours after surgery.
Multiple assessments during hospital stay up to 48 hours
Trial Site Locations
Total: 1 location
1
Poznan University of Medical Sciences
Poznan, Poland, 62-701
Actively Recruiting
Research Team
M
Malgorzata Reysner, M.D. Ph.D.
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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