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Completed

NCT Number: NCT06470100

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

Effect of perineurial dexamethasone and dexmedetomidine on erector spinal plane block duration for knee arthroplasty

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Key information

Age range

18 year–100 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Poznan University of Medical Sciences

Poznan, Poznań, 61-701, Poland

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • patients undergoing primary hip arthroplasty
  • aged >18 years and <100 years
  • ASA physical status 1, 2 or 3.

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.

Treatment and study plan

0.9% sodium chloride injection

Drug

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

Other names: placebo erector spinae plane block

Dexamethasone

Drug

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

Other names: erector spinae plane block

Dexmedetomidine

Drug

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

Other names: erector spinae plane block

Primary outcomes

  1. first need of opiate

    Time frame: 48 hours after surgery

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

Secondary outcomes

  1. Opioid consumption

    Time frame: 48 hours after surgery

    Total opioid consumption after surgery

  2. Numerical Rating Scale [range 0:10]

    Time frame: 4 hours after surgery

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

  3. Numerical Rating Scale [range 0:10]

    Time frame: 8 hours after surgery

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

  4. Numerical Rating Scale [range 0:10]

    Time frame: 12 hours after surgery

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

  5. Numerical Rating Scale [range 0:10]

    Time frame: 16 hours after surgery

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

  6. Numerical Rating Scale [range 0:10]

    Time frame: 20 hours after surgery

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

  7. Numerical Rating Scale [range 0:10]

    Time frame: 24 hours after surgery

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

  8. Numerical Rating Scale [range 0:10]

    Time frame: 36 hours after surgery

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

  9. Numerical Rating Scale [range 0:10]

    Time frame: 48 hours after surgery

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

  10. Nerve damage [range 0-4]

    Time frame: 12 hours after surgery

    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)

  11. Nerve damage [range 0-4]

    Time frame: 24 hours after surgery

    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)

  12. Nerve damage [range 0-4]

    Time frame: 48 hours after surgery

    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)

Sponsors and collaborators

Lead sponsor

Poznan University of Medical Sciences

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Jun 24, 2024
Registry last updated
Mar 30, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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