Dexamethasone versus dexmedetomidine added to erector spinae plane block for lumbar spine surgery
Comparison of Perineural Dexamethasone Versus Dexmedetomidine as Adjuvants to Erector Spinae Plane Block in Lumbar Spine Surgery: A Randomized, Double-blind, Controlled Trial
This test compares whether adding dexamethasone or dexmedetomidine to ropivacaine in an erector spinae plane block reduces pain and opioid use after lumbar spine surgery.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 150 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Poznan University of Medical Sciences Academic / other |
| Locations | 1 site (Poznan) |
| Trial ID | NCT07180940 on ClinicalTrials.gov |
What this trial studies
In this randomized, double-blind trial adult patients undergoing elective posterior lumbar spine surgery receive general anesthesia plus bilateral ultrasound-guided erector spinae plane blocks with ropivacaine and either dexamethasone or dexmedetomidine. Patients are randomly assigned to one of the two adjuvant groups and neither patients nor postoperative assessors know which drug was used. The primary outcomes are opioid consumption during the first 24 and 48 hours after surgery, with secondary measures including pain scores, time to first rescue analgesia, side effects (for example nausea or low blood pressure), and block-related complications. The trial is conducted at Poznan University of Medical Sciences and follows patients through the immediate postoperative hospitalization period.
Who should consider this trial
Good fit: Adults scheduled for elective posterior lumbar spine surgery (ASA I–III), weighing at least 50 kg, able to give consent and expected to stay in hospital at least 48 hours are ideal candidates.
Not a fit: Patients with allergies to the study drugs, chronic opioid dependence, significant liver or kidney dysfunction, uncontrolled diabetes, coagulopathy, BMI over 40, pregnancy or breastfeeding, or inability to cooperate are unlikely to benefit or be eligible.
Why it matters
Potential benefit: If one adjuvant proves better, it could lower opioid needs and improve pain control after lumbar spine surgery while reducing opioid-related side effects.
How similar studies have performed: Previous smaller studies indicate that perineural dexamethasone or dexmedetomidine can prolong peripheral nerve blocks and reduce opioid use, but direct head-to-head data for ESPB in lumbar surgery are limited.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Poznan
- Poznan University of Medical Sciences — Poznan, Poland (Recruiting)
Study contacts
- Study coordinator: Malgorzata Reysner, M.D. Ph.D.
- Email: mreysner@ump.edu.pl
- Phone: +48 61 873 83 03
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.