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CompletedNCT06470100Updated Mar 30, 2026

Dexamethasone vs. Dexmedetomidine for ESPB in Pain Management After Knee Arthroplasty

A Phase 4 interventional study of 0.9% Sodium Chloride Injection and Dexamethasone in Knee Osteoarthritis, Knee Arthritis and Knee Disease, 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 2026-03-30.

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 knee arthroplasty

Read the detailed description

This study is proposed to explore the effect of perineurial Dexamethasone and Dexmedetomidine on erector spinal plane block duration for knee surgery.

After knee surgery, patients need good analgesia. Peripheral nerve blocks have provided a safe, effective method to control early postoperative pain when symptoms are most severe.

Local anaesthesia's much lower toxicity threshold makes it essential for its safety. 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 comparing intravenous and perineural dexamethasone and Dexmedetomidine use in orthopaedic surgeries. However, there is a massive lack of research regarding knee surgery and the Erector Spine 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

  • Knee Osteoarthritis
  • Knee Arthritis
  • Knee Disease
  • Knee Pain Chronic
03

In context

Osteoarthritis, Knee

3,302 studies on the registry are indexed under Osteoarthritis, Knee; 608 are open to participants now.

This study's enrollment of 90 is above the median of 70 across 2,731 interventional studies indexed under Osteoarthritis, Knee.

Browse Osteoarthritis, Knee 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 hip arthroplasty
  • aged >18 years and \<100 years
  • ASA physical status 1, 2 or 3.

Exclusion criteria

Exclusion Criteria:

  • if they refused to participate,
  • had a history of opioid abuse,
  • had an infection of the site of needle puncture,
  • were less than 18 years of age,
  • were postponed as having ASA 4 or 5,
  • had an allergy to any of the drugs used in the study,
  • renal failure (estimated glomerular filtration rate \<15ml/min/1.73m2),
  • liver failure,
  • known or suspected coagulopathy,
  • pre-existing anatomical or neurological disorders in the lower extremities,
  • intellectual disability with problems in pain evaluation,
  • severe psychiatric illness.
05

Study design

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

Study arms

  • Placebo comparator
    Control group

    0.2% ropivacaine for erector spinae plane block

    Drug: 0.9% Sodium Chloride Injection

  • Experimental
    Dexamethasone

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

    Drug: Dexamethasone

  • Experimental
    Dexmedetomidine

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

    Drug: Dexmedetomidine

Interventions

  • Drug0.9% Sodium Chloride Injection

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

    Also known as: placebo erector spinae plane block

  • DrugDexamethasone

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

    Also known as: erector spinae plane block

  • DrugDexmedetomidine

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

    Also known as: erector spinae plane block

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 after surgery

Secondary outcomes

  1. Opioid consumption

    Total opioid consumption after surgery

    Time frame: 48 hours after surgery

  2. Numerical Rating Scale [range 0:10]

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

    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: 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: 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: 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: 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: 24 hours after surgery

  8. Numerical Rating Scale [range 0:10]

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

    Time frame: 36 hours after surgery

  9. Numerical Rating Scale [range 0:10]

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

    Time frame: 48 hours after surgery

  10. Nerve damage [range 0-4]

    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

  11. Nerve damage [range 0-4]

    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

  12. Nerve damage [range 0-4]

    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

07

Study locations

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

References and documents

Individual participant data

Plan to share: Yes — Individual patient data will be available two years following the completion of the trial

Supporting information: Study protocol

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 30, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06470100
Lead sponsor
Poznan University of Medical Sciences
Responsible party
Sponsor
First posted
Jun 24, 2024
Start date
Aug 13, 2024
Primary completion
Mar 3, 2026
Completion
Mar 20, 2026
Last update
Mar 30, 2026

Study contacts

Malgorzata Domagalska, M.D. PhD.
study chair · Poznań University of Medical Science

Oversight

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

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

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