A Phase 4 interventional study of 0.9%NaCl and Dexamethasone 4mg in Spine Disease and Spinal Diseases, sponsored by Poznan University of Medical Sciences. Recruiting at 1 site in Poland. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-09-18.
Sponsored by Poznan University of Medical Sciences · Phase 4, Interventional, and Treatment
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.
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 ropivacaine plus either dexamethasone or dexmedetomidine. Patients will be randomly assigned to one of these two groups, and neither the patient nor the doctors checking pain after surgery will know which medication was used.
The main goal is to see how much opioid pain medicine patients need during the first 24 and 48 hours after surgery. Other things we will look at include how strong the pain is, how soon pain relief is necessary, if there are any side effects like nausea or low blood pressure, and if there are any complications related to the block.
This study will help doctors choose the best option to manage pain after spine surgery while reducing the need for opioids and their side effects.
Exclusion Criteria:
Bilateral ESPB (2 x 20ml 0.2% ropivacaine with 1ml 0.9% NaCl)
Drug: 0.9%NaCl
Bilateral ESPB (2 x 20ml 0.2% ropivacaine with 2mg dexamethasone)
Drug: Dexamethasone 4mg
Bilateral ESPB (2 x 20ml 0.2% ropivacaine with 25ug dexmedetomidine)
Drug: Dexmedetomidine
2 x 20ml 0.2% ropivacaine with 2ml of 0.9% NaCl
2 x 20ml 0.2% ropivacaine with 2mg of dexamethasone
2 x 20ml 0.2% ropivacaine with 25ug Dexmedetomidine
Total opioid Consuption
Cumulative opioid consumption during the first 24 and 48 hours after surgery, converted to morphine milligram equivalents (MME)
Time frame: 48 hours after surgery
NRS
Numerical Rating Scale (0 - no pain; 10 - the worst pain ever)
Time frame: 4 hours after surgery
NRS
Numerical Rating Scale (0 - no pain; 10 - the worst pain ever)
Time frame: 8 hours after surgery
NRS
Numerical Rating Scale (0 - no pain; 10 - the worst pain ever)
Time frame: 12 hours after surgery
NRS
Numerical Rating Scale (0 - no pain; 10 - the worst pain ever)
Time frame: 24 hours after surgery
NRS
Numerical Rating Scale (0 - no pain; 10 - the worst pain ever)
Time frame: 48 hours after surgery
Nerve injury
Nerve damage assesment will be performed using the nerve damage score (N0- no nerve damage; N1- minor - sensory paresthesia; N2- major -complete sensory anesthesia; N3- Complete- complete motor defect with or without paraesthesia; N4-CRPS- Complex Regional Pain Syndrome)
Time frame: 12 hours after surgery
Nerve injury
Nerve damage assesment will be performed using the nerve damage score (N0- no nerve damage; N1- minor - sensory paresthesia; N2- major -complete sensory anesthesia; N3- Complete- complete motor defect with or without paraesthesia; N4-CRPS- Complex Regional Pain Syndrome)
Time frame: 24 hours after surgery
Nerve injury
Nerve damage assesment will be performed using the nerve damage score (N0- no nerve damage; N1- minor - sensory paresthesia; N2- major -complete sensory anesthesia; N3- Complete- complete motor defect with or without paraesthesia; N4-CRPS- Complex Regional Pain Syndrome)
Time frame: 48 hours after surgery
adverce effects
nausea, vomitting, bradycardia, hypotension
Time frame: 48 hours after surgery
Time to first rescue analgesia
Time after surgery when the patient needs rescue analgesia for the first time
Time frame: 48 hours after surgery
blood glucose
Blood glucose concentration measured postoperatively
Time frame: 12 hours after surgery
blood glucose
Blood glucose concentration measured postoperatively
Time frame: 24 hours after surgery
blood glucose
Blood glucose concentration measured postoperatively
Time frame: 48 hours after surgery
NLR - Neutrophil-to-Lymphocyte Ratio
NLR will be calculated from complete blood count results
Time frame: 12 hours after surgery
NLR - Neutrophil-to-Lymphocyte Ratio
NLR will be calculated from complete blood count results
Time frame: 24 hours after surgery
NLR - Neutrophil-to-Lymphocyte Ratio
NLR will be calculated from complete blood count results
Time frame: 48 hours after surgery
PLR - Platelet-to-Lymphocyte Ratio
PLR will be calculated from complete blood count results
Time frame: 12 hours after surgery
PLR - Platelet-to-Lymphocyte Ratio
PLR will be calculated from complete blood count results
Time frame: 24 hours after surgery
PLR - Platelet-to-Lymphocyte Ratio
PLR will be calculated from complete blood count results
Time frame: 48 hours after surgery
Plan to share: Yes
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Poznan University of Medical Sciences