Spine DiseasePhase 4NCT07180940
Comparison of Perineural Dexamethasone Versus Dexmedetomidine as Adjuvants to Erector Spinae Plane Block in Lumbar Spine Surgery
A Phase 4 study testing 0.9%NaCl, Dexamethasone 4mg and Dexmedetomidine in people with Spine Disease and Spinal Diseases, run by Poznan University of Medical Sciences at 1 site in Poland.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Spine Disease, Spinal Diseases
- What is being tested?
- 0.9%NaCl, Dexamethasone 4mg and Dexmedetomidine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 150 participants
- Where
- 1 sitePoland
- Study dates
- 1 Sep 2025to 31 Dec 2025
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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%)
Show all 10Show fewer
- Severe hepatic or renal dysfunction
- Body mass index (BMI) > 40 kg/m²
- Pregnancy or breastfeeding
- Refusal or inability to cooperate with the study protocol
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the detailed description
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.
- Conditions
- Spine Disease, Spinal Diseases
- Being tested
- 0.9%NaCl, Dexamethasone 4mg, Dexmedetomidine
- Medical subject headings
- Spinal Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
0.9%NaClDrug
2 x 20ml 0.2% ropivacaine with 2ml of 0.9% NaCl
Dexamethasone 4mgDrug
2 x 20ml 0.2% ropivacaine with 2mg of dexamethasone
DexmedetomidineDrug
2 x 20ml 0.2% ropivacaine with 25ug Dexmedetomidine
| Study group | Role | What they receive |
|---|---|---|
| Control group | Placebo comparator | Bilateral ESPB (2 x 20ml 0.2% ropivacaine with 1ml 0.9% NaCl) Receives: Drug: 0.9%NaCl |
| Dexamethasone group | Experimental | Bilateral ESPB (2 x 20ml 0.2% ropivacaine with 2mg dexamethasone) Receives: Drug: Dexamethasone 4mg |
| Dexmedetomidine group | Experimental | Bilateral ESPB (2 x 20ml 0.2% ropivacaine with 25ug dexmedetomidine) Receives: Drug: Dexmedetomidine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total opioid Consuption
Cumulative opioid consumption during the first 24 and 48 hours after surgery, converted to morphine milligram equivalents (MME)
Measured: 48 hours after surgery
Secondary outcomes (19)
NRS
Numerical Rating Scale (0 - no pain; 10 - the worst pain ever)
Measured: 4 hours after surgery
NRS
Numerical Rating Scale (0 - no pain; 10 - the worst pain ever)
Measured: 8 hours after surgery
NRS
Numerical Rating Scale (0 - no pain; 10 - the worst pain ever)
Measured: 12 hours after surgery
NRS
Numerical Rating Scale (0 - no pain; 10 - the worst pain ever)
Measured: 24 hours after surgery
NRS
Numerical Rating Scale (0 - no pain; 10 - the worst pain ever)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 48 hours after surgery
adverce effects
nausea, vomitting, bradycardia, hypotension
Measured: 48 hours after surgery
Time to first rescue analgesia
Time after surgery when the patient needs rescue analgesia for the first time
Measured: 48 hours after surgery
blood glucose
Blood glucose concentration measured postoperatively
Measured: 12 hours after surgery
blood glucose
Blood glucose concentration measured postoperatively
Measured: 24 hours after surgery
blood glucose
Blood glucose concentration measured postoperatively
Measured: 48 hours after surgery
NLR - Neutrophil-to-Lymphocyte Ratio
NLR will be calculated from complete blood count results
Measured: 12 hours after surgery
NLR - Neutrophil-to-Lymphocyte Ratio
NLR will be calculated from complete blood count results
Measured: 24 hours after surgery
NLR - Neutrophil-to-Lymphocyte Ratio
NLR will be calculated from complete blood count results
Measured: 48 hours after surgery
PLR - Platelet-to-Lymphocyte Ratio
PLR will be calculated from complete blood count results
Measured: 12 hours after surgery
PLR - Platelet-to-Lymphocyte Ratio
PLR will be calculated from complete blood count results
Measured: 24 hours after surgery
PLR - Platelet-to-Lymphocyte Ratio
PLR will be calculated from complete blood count results
Measured: 48 hours after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Sep 2025
- Study start1 Sep 2025
- Primary completion30 Dec 2025
- Study completion31 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Spine DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- Poznan University of Medical Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07180940
- Sponsor's protocol ID
- 01/2025
- Status last verified
- Nov 2026
- First submitted
- 12 Sep 2025
- Last updated
- 6 Nov 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 6 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Perineural Dexamethasone Versus Dexmedetomidine as Adjuvants to Erector Spinae Plane Block in Lumbar Spine Surgery
- ClinicalTrials.gov ID
- NCT07180940
- Acronym / sponsor ID
- 01/2025
- Conditions
- Spine Disease, Spinal Diseases
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- Poznan University of Medical SciencesUniversity, hospital or other
- Study start
- 1 Sep 2025 (actual)
- Primary completion
- 30 Dec 2025 (actual)
- Study completion
- 31 Dec 2025 (actual)
- First posted
- 18 Sep 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Control group | Placebo comparator | Drug: 0.9%NaClBilateral ESPB (2 x 20ml 0.2% ropivacaine with 1ml 0.9% NaCl) |
| Dexamethasone group | Experimental | Drug: Dexamethasone 4mgBilateral ESPB (2 x 20ml 0.2% ropivacaine with 2mg dexamethasone) |
| Dexmedetomidine group | Experimental | Drug: DexmedetomidineBilateral ESPB (2 x 20ml 0.2% ropivacaine with 25ug dexmedetomidine) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 0.9%NaCl2 x 20ml 0.2% ropivacaine with 2ml of 0.9% NaCl | Drug | Control group |
| Dexamethasone 4mg2 x 20ml 0.2% ropivacaine with 2mg of dexamethasone | Drug | Dexamethasone group |
| Dexmedetomidine2 x 20ml 0.2% ropivacaine with 25ug Dexmedetomidine | Drug | Dexmedetomidine group |
Primary outcome
Total opioid Consuption
Time frame: 48 hours after surgery
Cumulative opioid consumption during the first 24 and 48 hours after surgery, converted to morphine milligram equivalents (MME)
19 secondary outcomes
NRS
Time frame: 4 hours after surgery
NRS
Time frame: 8 hours after surgery
NRS
Time frame: 12 hours after surgery
NRS
Time frame: 24 hours after surgery
NRS
Time frame: 48 hours after surgery
Nerve injury
Time frame: 12 hours after surgery
Nerve injury
Time frame: 24 hours after surgery
Nerve injury
Time frame: 48 hours after surgery
adverce effects
Time frame: 48 hours after surgery
Time to first rescue analgesia
Time frame: 48 hours after surgery
blood glucose
Time frame: 12 hours after surgery
blood glucose
Time frame: 24 hours after surgery
blood glucose
Time frame: 48 hours after surgery
NLR - Neutrophil-to-Lymphocyte Ratio
Time frame: 12 hours after surgery
NLR - Neutrophil-to-Lymphocyte Ratio
Time frame: 24 hours after surgery
NLR - Neutrophil-to-Lymphocyte Ratio
Time frame: 48 hours after surgery
PLR - Platelet-to-Lymphocyte Ratio
Time frame: 12 hours after surgery
PLR - Platelet-to-Lymphocyte Ratio
Time frame: 24 hours after surgery
PLR - Platelet-to-Lymphocyte Ratio
Time frame: 48 hours after surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Nov 2026.
- Individual participant dataSharing planned: Yes
Related trials for Spine Disease
Recruiting
Lumbar Paravertebral Block vs Erector Spinae Plane Block in Elderly Patients Undergoing Lumbar Spine Surgery
Spine Disease
Active, not recruiting
Post Marketing Study of MagnetOs Easypack Putty Standalone Compared to Demineralized Bone Matrix or Fibers Mixed With Autograft in Patients Undergoing Posterolateral Lumbar Fusion
Degenerative Disc Disease, Spine Fusion
Recruiting
FIBERGRAFT Aeridyan Posterolateral Fusion Study
Degenerative Spine Disease
Not yet recruiting
Kore Fiber PLF Study
Degenerative Lumbar Spine Diseases, Lumbar Degenerative Disc Disease
Recruiting
MagnetOs Flex Matrix Compared to Trinity Elite Mixed With Local Autograft in Patients Undergoing up to Four-level Instrumented Posterolateral Fusion
Degenerative Disc Disease, Spine Fusion
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing 0.9%NaCl, Dexamethasone 4mg and Dexmedetomidine in people with Spine Disease and Spinal Diseases, run by Poznan University of Medical Sciences at 1 site in Poland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Poland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Total opioid Consuption (time frame: 48 hours after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Nov 2026; AzTrials last refreshed its copy on 8 Nov 2026.