Clinical trial NCT06470204: Dexamethasone for IPACK Block with ACB in Total Knee Arthroplasty
Official title: Infiltration Between the Popliteal Artery and Capsule of the Knee Block with Adductor Canal Block with Ropivacaine Vs Ropivacaine and Dexamethasone in Total Knee Arthroplasty: a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE4
Conditions: Knee Osteoarthritis
Knee Pain Chronic
Knee Arthritis
Lead sponsor: Poznan University of Medical Sciences
Sponsor class: OTHER
First posted: 2024-06-24
Enrollment: 60
Sex: ALL
Minimum age (years): 65
Maximum age (years): 100
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Effect of adding Dexamethasone to Infiltration between the Popliteal Artery and Capsule of the Knee Block with ACB in Patients undergoing Total Knee Arthroplasty

Detailed description: Knee 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 surgery
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: glucose
timeFrame: 12 hours after surgery
measure: glucose
timeFrame: 24 hours after surgery
measure: glucose
timeFrame: 48 hours after surgery
Other outcomes:
Locations:
city: Poznan
country: Poland
facility: Poznan University of Medical Sciences
state: Poznań
Study officials:
affiliation: Poznań University of Medical Sciences
name: Malgorzata Domagalska, M.D. Ph.D.
role: STUDY_CHAIR
References: