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CompletedNCT06233617Updated May 11, 2026

Dexamethasone vs. Dexmedetomidine for ESPB in Pain Management After Spine Surgery

A Phase 4 interventional study of 0.9% Sodium Chloride Injection and Dexamethasone 4 Mg/mL Injectable Solution in Spinal Fusion, Spine Disease and Spinal Stenosis, sponsored by Poznan University of Medical Sciences. Completed at 1 site in Poland. Open to participants aged 18 Years to 100 Years. Per ClinicalTrials.gov, last updated 2026-05-11.

Sponsored by Poznan University of Medical Sciences · Phase 4, Interventional, and Treatment

Phase
Phase 4
Study type
Interventional
Enrollment
90
Allocation
Randomized
Ages
18 Years to 100 Years
Sex
All
01

Study summary

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.

02

Conditions studied

  • Spinal Fusion
  • Spine Disease
  • Spinal Stenosis
  • Erector Spinae Plane Block
03

In context

Spinal Diseases

267 studies on the registry are indexed under Spinal Diseases; 54 are open to participants now.

This study's enrollment of 90 is above the median of 52 across 166 interventional studies indexed under Spinal Diseases.

Browse Spinal Diseases studies →

Lead sponsor

Poznan University of Medical Sciences is the lead sponsor of 143 studies on the registry; 46 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 100 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • 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.

Exclusion criteria

Exclusion Criteria:

  • refuse to participate,
  • history of opioid abuse,
  • infection of the puncture site,
  • aged \<18 years and >100 years
  • ASA 4 and 5
05

Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Participant, Care provider, Outcomes assessor)
Enrollment
90 participants (actual)

Study arms

  • Placebo comparator
    placebo

    0.2% ropivacaine for erector spinae plane block

    Drug: 0.9% Sodium Chloride Injection

  • Active comparator
    Dexamethasone

    0.2% ropivacaine + 4mg Dexamethasone for erector spinae plane block

    Drug: Dexamethasone 4 Mg/mL Injectable Solution

  • Active comparator
    Dexmedetomidine

    0.2% ropivacaine + 50ug Dexmedetomidine for erector spinae plane block

    Drug: Dexmedetomidine injection

Interventions

  • Drug0.9% Sodium Chloride Injection

    biliteral administration of 20ml of 0,2% ropivacaine + 2ml 0.9% sodium chloride for the erector spine plane block

    Also known as: 0.9% Sodium Chloride iv.

  • DrugDexamethasone 4 Mg/mL Injectable Solution

    biliteral administration of 20ml of 0,2% ropivacaine with 4mg Dexamethasone for the erector spine plane block

    Also known as: 0,2% ropivacaine with 4mg Dexamethasone iv

  • DrugDexmedetomidine injection

    biliteral administration of 20ml of 0,2% ropivacaine with 50ug Dexmedetomidine for the erector spine plane block

    Also known as: 0,2% ropivacaine with 50ug Dexmedetomidine

06

What researchers measure

Primary outcomes

  1. first need of opiate

    Time after surgery when the patient needs opiate for the first time

    Time frame: 48 hours

Secondary outcomes

  1. Opioid consumption

    Total opiate consumption after surgery

    Time frame: 48 hours

  2. Numerical Rating Scale [range 0:10]

    NRS (Numerical Rating Scale; 0 - no pain; 10 - the worst pain ever)

    Time frame: Time Frame: 4 hours after surgery

  3. Numerical Rating Scale [range 0:10]

    NRS (Numerical Rating Scale; 0 - no pain; 10 - the worst pain ever)

    Time frame: Time Frame: 8 hours after surgery

  4. Numerical Rating Scale [range 0:10]

    NRS (Numerical Rating Scale; 0 - no pain; 10 - the worst pain ever)

    Time frame: Time Frame: 12 hours after surgery

  5. Numerical Rating Scale [range 0:10]

    NRS (Numerical Rating Scale; 0 - no pain; 10 - the worst pain ever)

    Time frame: Time Frame: 16 hours after surgery

  6. Numerical Rating Scale [range 0:10]

    NRS (Numerical Rating Scale; 0 - no pain; 10 - the worst pain ever)

    Time frame: Time Frame: 20 hours after surgery

  7. Numerical Rating Scale [range 0:10]

    NRS (Numerical Rating Scale; 0 - no pain; 10 - the worst pain ever)

    Time frame: Time Frame: 24 hours after surgery

  8. NLR

    Neutrophil-to-lymphocyte ratio

    Time frame: 48 hours after surgery

  9. PLR

    Platelet-to-lymphocyte ratio

    Time frame: 48 hours after surgery

07

Study locations

1 site
  • Poznan University of Medical Sciences
    Poznan, Poznań 61-701, Poland
08

References and documents

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 ↗

Individual participant data

Plan to share: No

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 11, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06233617
Lead sponsor
Poznan University of Medical Sciences
Responsible party
Sponsor
First posted
Jan 31, 2024
Start date
Mar 1, 2024
Primary completion
Dec 31, 2025
Completion
Jan 15, 2026
Last update
May 11, 2026

Study contacts

Malgorzata Domagalska, PhD
principal investigator · Poznań University of Medical Sciences

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Apr 2024. You cannot join it, but the record below documents what was studied.

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