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

NCT06470100 | Completed Phase 4

• 1 other identifier: 107/24
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Knee Arthritis; Knee Disease; Knee Pain Chronic; Knee Osteoarthritis

Outcome Measures

Primary Outcomes (1)

• first need of opiate

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

  48 hours after surgery

Secondary Outcomes (12)

• Opioid consumption

  48 hours after surgery

• Numerical Rating Scale [range 0:10]

  4 hours after surgery

• Numerical Rating Scale [range 0:10]

  8 hours after surgery

• Numerical Rating Scale [range 0:10]

  12 hours after surgery

• Numerical Rating Scale [range 0:10]

  16 hours after surgery

Study Arms (3)

Control group

PLACEBO COMPARATOR

0.2% ropivacaine for erector spinae plane block

Drug: 0.9% Sodium Chloride Injection

Dexamethasone

EXPERIMENTAL

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

Drug: Dexamethasone

Dexmedetomidine

EXPERIMENTAL

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

Drug: Dexmedetomidine

Interventions

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

Also known as: placebo erector spinae plane block

Control group

Dexamethasone DRUG

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

Also known as: erector spinae plane block

Dexamethasone

Dexmedetomidine DRUG

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

Also known as: erector spinae plane block

Dexmedetomidine

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Poznan University of Medical Sciences: lead

Study Sites (1)

Poznan University of Medical Sciences

Poznan, Poznań, 61-701, Poland

Location

MeSH Terms

Conditions

Osteoarthritis, Knee

Interventions

Sodium Chloride; Dexamethasone; Dexmedetomidine

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Intervention Hierarchy (Ancestors)

Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds; Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated; Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Malgorzata Domagalska, M.D. PhD.

  Poznań University of Medical Science

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 17, 2024
• First Posted: June 24, 2024
• Study Start: August 13, 2024
• Primary Completion: March 3, 2026
• Study Completion: March 20, 2026
• Last Updated: March 30, 2026

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: 2 years after finish study
• Access Criteria: elligible researchers

Locations

PL (1)