Clinical trial NCT06789042: Dexamethasone for ESPB in Total Hip Arthroplasty
Official title: Efficacy of Perineural Dexamethasone to Prolong Anesthesia After Erector Spinae Plane Block for Total Hip Arthroplasty
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE4
Conditions: Hip Osteoarthritis
Hip Arthropathy
Hip Arthritis
Keywords: erector spinae plane block
total hip arthroplasty
pain management
perineural adjuvant
Lead sponsor: Poznan University of Medical Sciences
Sponsor class: OTHER
First posted: 2025-01-23
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Effect of adding Dexamethasone to Erector Spinae Plane Block in Patients undergoing Total Hip Arthroplasty

Detailed description: Hip arthroplasty is one of the most common orthopaedic procedures, especially in elderly patients, due to the deformation of joints. Patients may complain of severe pain due to surgical trauma and prostheses. Regional anaesthesia methods may be performed to reduce the inflammatory response, opioid consumption, and opioid-related side effects.

Eligibility criteria: Inclusion Criteria:

* patients scheduled for total hip arthroplasty
* patients aged \>65 and \<100 years
* patients able to provide informed consent
* patients able to reliably report symptoms to the research team

Exclusion Criteria:

* inability to provide first-party consent due to cognitive impairment or a language barrier

Primary outcomes:
measure: Time to first rescue opioid analgesia
timeFrame: 48 hours after surgery
Secondary outcomes:
measure: Total Opioid Consumption
timeFrame: 48 hours after procedure
measure: Numerical Rating Scale [range 0:10]
timeFrame: 4 hours after surgery
measure: Numerical Rating Scale [range 0:10]
timeFrame: 8 hours after surgery
measure: Numerical Rating Scale [range 0:10]
timeFrame: 12 hours after surgery
measure: Numerical Rating Scale [range 0:10]
timeFrame: 24 hours after surgery
measure: Numerical Rating Scale [range 0:10]
timeFrame: 48 hours after surgery
measure: Quadriceps muscle strength assessed using medical research council scale [range 0:5]
timeFrame: 4 hours after surgery
measure: Quadriceps muscle strength assessed using medical research council scale [range 0:5]
timeFrame: 8 hours after surgery
measure: Quadriceps muscle strength assessed using medical research council scale [range 0:5]
timeFrame: 12 hours after surgery
measure: Quadriceps muscle strength assessed using medical research council scale [range 0:5]
timeFrame: 24 hours after surgery
measure: Quadriceps muscle strength assessed using medical research council scale [range 0:5]
timeFrame: 48 hours after surgery
measure: Nerve damage [range 0-4]
timeFrame: 12 hours after surgery
measure: Nerve damage [range 0-4]
timeFrame: 24 hours after surgery
measure: Nerve damage [range 0-4]
timeFrame: 48 hours after surgery
measure: blood glucose
timeFrame: 12 hours after surgery
measure: blood glucose
timeFrame: 24 hours after surgery
measure: blood glucose
timeFrame: 48 hours after surgery
Other outcomes:
Locations:
city: Poznan
country: Poland
facility: Poznan University of Medical Sciences
state: Wielkopolska
Study officials:
affiliation: Poznań University of Medical Science
name: Malgorzata Resyner, MD PhD
role: STUDY_DIRECTOR
References: