Spinal FusionPhase 4NCT06233617
Dexamethasone vs. Dexmedetomidine for ESPB in Pain Management After Spine Surgery
A Phase 4 study testing 0.9% Sodium Chloride Injection, Dexamethasone 4 Mg/mL Injectable Solution and Dexmedetomidine injection in people with Spinal Fusion and Spine Disease, run by Poznan University of Medical Sciences at 1 site in Poland.
Trial summary
Effect of perineurial dexamethasone and dexmedetomidine on erector spinal plane block duration for spine surgery. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Spinal Fusion, Spine Disease, Spinal Stenosis
- What is being tested?
- 0.9% Sodium Chloride Injection, Dexamethasone 4 Mg/mL Injectable Solution and Dexmedetomidine injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 90 participants
- Where
- 1 sitePoland
- Study dates
- 1 Mar 2024to 15 Jan 2026
- 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 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- patients undergoing primary posterior lumbar decompression and stabilization with instrumentation involving multi-levels in the lumbar region,
- aged >18 years and <100 years
- ASA physical status 1, 2 or 3.
Who cannot join
- refuse to participate,
- history of opioid abuse,
- infection of the puncture site,
- aged <18 years and >100 years
- ASA 4 and 5
Trial locations and contacts
1 site in 1 country.
About this study
Effect of perineurial dexamethasone and dexmedetomidine on erector spinal plane block duration for spine surgery.
Read the detailed description
This study is proposed to explore the effect of perineurial Dexamethasone and Dexmedetomidine on erector spinal plane block duration for spine surgery.
After spine surgery, patients need good analgesia. Peripheral nerve blocks have provided a safe, effective method to control early postoperative pain when symptoms are most severe.
The safety of local anaesthesia is essential due to the much lower toxicity threshold of local anaesthetics. An effective adjuvant, such as Dexamethasone or Dexmedetomidine, could allow for a higher dilution of local anaesthetics while maintaining and enhancing their analgesic effect.
There is considerable research where intravenous and perineural dexamethasone and Dexmedetomidine use have been compared in adults. However, there is a massive lack of research regarding spine surgery and the Erector Spinae Plane Block.
In this study, investigators compare perineural Dexamethasone and Dexmedetomidine.
The investigator aims to find a dexamethasone or dexmedetomidine that covers the need for good pain relief and fast recovery postoperatively.
- Being tested
- 0.9% Sodium Chloride Injection, Dexamethasone 4 Mg/mL Injectable Solution, Dexmedetomidine injection
- Medical subject headings
- Spinal Diseases, Spinal Stenosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
0.9% Sodium Chloride InjectionDrug
Also called 0.9% Sodium Chloride iv.
biliteral administration of 20ml of 0,2% ropivacaine + 2ml 0.9% sodium chloride for the erector spine plane block
Dexamethasone 4 Mg/mL Injectable SolutionDrug
Also called 0,2% ropivacaine with 4mg Dexamethasone iv
biliteral administration of 20ml of 0,2% ropivacaine with 4mg Dexamethasone for the erector spine plane block
Dexmedetomidine injectionDrug
Also called 0,2% ropivacaine with 50ug Dexmedetomidine
biliteral administration of 20ml of 0,2% ropivacaine with 50ug Dexmedetomidine for the erector spine plane block
| Study group | Role | What they receive |
|---|---|---|
| placebo | Placebo comparator | 0.2% ropivacaine for erector spinae plane block Receives: Drug: 0.9% Sodium Chloride Injection |
| Dexamethasone | Active comparator | 0.2% ropivacaine + 4mg Dexamethasone for erector spinae plane block Receives: Drug: Dexamethasone 4 Mg/mL Injectable Solution |
| Dexmedetomidine | Active comparator | 0.2% ropivacaine + 50ug Dexmedetomidine for erector spinae plane block Receives: Drug: Dexmedetomidine injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
first need of opiate
Time after surgery when the patient needs opiate for the first time
Measured: 48 hours
Secondary outcomes (9)
Opioid consumption
Total opiate consumption after surgery
Measured: 48 hours
Numerical Rating Scale [range 0:10]
NRS (Numerical Rating Scale; 0 - no pain; 10 - the worst pain ever)
Measured: Time Frame: 4 hours after surgery
Numerical Rating Scale [range 0:10]
NRS (Numerical Rating Scale; 0 - no pain; 10 - the worst pain ever)
Measured: Time Frame: 8 hours after surgery
Numerical Rating Scale [range 0:10]
NRS (Numerical Rating Scale; 0 - no pain; 10 - the worst pain ever)
Measured: Time Frame: 12 hours after surgery
Numerical Rating Scale [range 0:10]
NRS (Numerical Rating Scale; 0 - no pain; 10 - the worst pain ever)
Measured: Time Frame: 16 hours after surgery
Numerical Rating Scale [range 0:10]
NRS (Numerical Rating Scale; 0 - no pain; 10 - the worst pain ever)
Measured: Time Frame: 20 hours after surgery
Numerical Rating Scale [range 0:10]
NRS (Numerical Rating Scale; 0 - no pain; 10 - the worst pain ever)
Measured: Time Frame: 24 hours after surgery
NLR
Neutrophil-to-lymphocyte ratio
Measured: 48 hours after surgery
PLR
Platelet-to-lymphocyte ratio
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 posted31 Jan 2024
- Study start1 Mar 2024
- Primary completion31 Dec 2025
- Study completion15 Jan 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Spinal FusionStudies 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
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Poznan University of Medical Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Malgorzata Domagalska, PhD, Principal investigator, Poznań University of Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06233617
- Sponsor's protocol ID
- 3/2024
- Status last verified
- Apr 2024
- First submitted
- 22 Jan 2024
- Last updated
- 11 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Reysner T, Ciftci B, Alver S, Wieczorowska-Tobis K, Neumann-Podczaska A, Reysner M. Do Perineural Dexamethasone and Dexmedetomidine Improve Analgesia and Inflammatory Response After Lumbar Spine Surgery? Clin Orthop Relat Res. 2026 Jun 5. doi: 10.1097/CORR.0000000000004008. Online ahead of print.
PubMed 42246693
Study at a glance
From the registry record, last updated by the sponsor on 11 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dexamethasone vs. Dexmedetomidine for ESPB in Pain Management After Spine Surgery
- ClinicalTrials.gov ID
- NCT06233617
- Acronym / sponsor ID
- 3/2024
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Poznan University of Medical SciencesUniversity, hospital or other
- Study start
- 1 Mar 2024 (actual)
- Primary completion
- 31 Dec 2025 (actual)
- Study completion
- 15 Jan 2026 (actual)
- First posted
- 31 Jan 2024 (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.
Effect of perineurial dexamethasone and dexmedetomidine on erector spinal plane block duration for spine surgery.
Detailed description
This study is proposed to explore the effect of perineurial Dexamethasone and Dexmedetomidine on erector spinal plane block duration for spine surgery.
After spine surgery, patients need good analgesia. Peripheral nerve blocks have provided a safe, effective method to control early postoperative pain when symptoms are most severe.
The safety of local anaesthesia is essential due to the much lower toxicity threshold of local anaesthetics. An effective adjuvant, such as Dexamethasone or Dexmedetomidine, could allow for a higher dilution of local anaesthetics while maintaining and enhancing their analgesic effect.
There is considerable research where intravenous and perineural dexamethasone and Dexmedetomidine use have been compared in adults. However, there is a massive lack of research regarding spine surgery and the Erector Spinae Plane Block.
In this study, investigators compare perineural Dexamethasone and Dexmedetomidine.
The investigator aims to find a dexamethasone or dexmedetomidine that covers the need for good pain relief and fast recovery postoperatively.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| placebo | Placebo comparator | Drug: 0.9% Sodium Chloride Injection0.2% ropivacaine for erector spinae plane block |
| Dexamethasone | Active comparator | Drug: Dexamethasone 4 Mg/mL Injectable Solution0.2% ropivacaine + 4mg Dexamethasone for erector spinae plane block |
| Dexmedetomidine | Active comparator | Drug: Dexmedetomidine injection0.2% ropivacaine + 50ug Dexmedetomidine for erector spinae plane block |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- patients undergoing primary posterior lumbar decompression and stabilization with instrumentation involving multi-levels in the lumbar region,
- aged >18 years and <100 years
- ASA physical status 1, 2 or 3.
Key exclusion criteria (5 listed)
- refuse to participate,
- history of opioid abuse,
- infection of the puncture site,
- aged <18 years and >100 years
- ASA 4 and 5
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% Sodium Chloride InjectionAlso: 0.9% Sodium Chloride iv.biliteral administration of 20ml of 0,2% ropivacaine + 2ml 0.9% sodium chloride for the erector spine plane block | Drug | placebo |
| Dexamethasone 4 Mg/mL Injectable SolutionAlso: 0,2% ropivacaine with 4mg Dexamethasone ivbiliteral administration of 20ml of 0,2% ropivacaine with 4mg Dexamethasone for the erector spine plane block | Drug | Dexamethasone |
| Dexmedetomidine injectionAlso: 0,2% ropivacaine with 50ug Dexmedetomidinebiliteral administration of 20ml of 0,2% ropivacaine with 50ug Dexmedetomidine for the erector spine plane block | Drug | Dexmedetomidine |
Primary outcome
first need of opiate
Time frame: 48 hours
Time after surgery when the patient needs opiate for the first time
9 secondary outcomes
Opioid consumption
Time frame: 48 hours
Numerical Rating Scale [range 0:10]
Time frame: Time Frame: 4 hours after surgery
Numerical Rating Scale [range 0:10]
Time frame: Time Frame: 8 hours after surgery
Numerical Rating Scale [range 0:10]
Time frame: Time Frame: 12 hours after surgery
Numerical Rating Scale [range 0:10]
Time frame: Time Frame: 16 hours after surgery
Numerical Rating Scale [range 0:10]
Time frame: Time Frame: 20 hours after surgery
Numerical Rating Scale [range 0:10]
Time frame: Time Frame: 24 hours after surgery
NLR
Time frame: 48 hours after surgery
PLR
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 11 May 2026.
- Derived from this study: PubMed 42246693Reysner T, Ciftci B, Alver S, Wieczorowska-Tobis K, Neumann-Podczaska A, Reysner M. Do Perineural Dexamethasone and Dexmedetomidine Improve Analgesia and Inflammatory Response After Lumbar Spine Surgery? Clin Orthop Relat Res. 2026 Jun 5. doi: 10.1097/CORR.0000000000004008. Online ahead of print.
- Individual participant dataSharing planned: No
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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.
Malgorzata Domagalska, PhD principal investigator
Poznań University of Medical Sciences
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% Sodium Chloride Injection, Dexamethasone 4 Mg/mL Injectable Solution and Dexmedetomidine injection in people with Spinal Fusion and Spine Disease, 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 3 inclusion and 5 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 11 May 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?
first need of opiate (time frame: 48 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06233617, which also lists 1 linked publication.
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 11 May 2026.