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. Completed at 1 site in Poland. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-11-06.
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.
174 studies on the registry are indexed under Spinal Diseases; 39 are open to participants now.
This study's enrollment of 150 is above the median of 60 across 106 interventional studies indexed under Spinal Diseases.
Browse Spinal Diseases studies →Poznan University of Medical Sciences is the lead sponsor of 151 studies on the registry; 41 are open to participants now.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
A blood test of average blood sugar over the past two to three months, given as a percentage or in mmol/mol. 6.5% (48 mmol/mol) or more is the usual threshold for diabetes, normally confirmed by a second test.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
ASA physical status
The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HbA1c
A blood test of average blood sugar over the past two to three months, given as a percentage or in mmol/mol. 6.5% (48 mmol/mol) or more is the usual threshold for diabetes, normally confirmed by a second test.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
No publications or documents are linked to this record.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is completed, as verified in Nov 2026. You cannot join it, but the record below documents what was studied.
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Studies of the drugs tested here: Dexamethasone · Dexmedetomidine
Poznan University of Medical Sciences →