Impact of Dexamethasone Route on Pain and Inflammation in iPACK With ACB for Knee Arthroplasty

Poznan University of Medical Sciences (PUMS)

Status and phase: Enrolling; Phase 4

Conditions: Knee Pain Chronic; Arthropathy of Knee; Osteoarthritis, Knee

Treatments: Drug: NaCl 0.9%; Drug: Dexamethasone 4mg

Study type: Interventional

Funder types: Other

Identifiers

NCT07180953

02/20025

Details and patient eligibility

About

"The Effect of Dexamethasone Administration Route on Pain and Inflammatory Response in iPACK With ACB for Total Knee Arthroplasty" - written in plain language according to ClinicalTrials.gov standards:

The goal of this clinical trial is to learn how the route of dexamethasone administration (either through the vein or nerve block) affects pain and inflammation in people having total knee replacement surgery. All participants will receive two types of nerve blocks before surgery: an iPACK block and an adductor canal block (ACB), which help control pain after the operation.

The main questions the study aims to answer are:

Does injecting dexamethasone into the nerve block reduce pain more effectively than giving it by vein? Which method leads to a lower inflammatory response after surgery? Researchers will compare the two groups to see which route offers better pain relief and less swelling after knee surgery.

Participants will:

Be randomly assigned to receive dexamethasone either in the nerve block or by IV Receive standard care for total knee replacement Rate their pain and have blood tests after surgery to measure inflammation

Enrollment: 90 estimated patients

Sex: All

Ages: 65 to 100 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• patients scheduled for total knee arthroplasty
• patients aged >65 and <100 years
• patients can provide informed consent
• patients can reliably report symptoms to the research team

Exclusion criteria

• inability to provide first-party consent due to cognitive impairment or a
• language barrier
• infection at the site of the regional block,
• coagulation disorders,
• immunodeficiency,
• American Society of Anesthesiologists (ASA) physical status of IV or higher,
• history of regular steroid medication.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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90 participants in 3 patient groups, including a placebo group

Control

Placebo Comparator group

Description:

iPACK block with ACB

Treatment:

Drug: NaCl 0.9%

iv DEX

Active Comparator group

Description:

iPACK block with ACB + iv Dexamethasone

Treatment:

Drug: Dexamethasone 4mg

Drug: Dexamethasone 4mg

pn DEX

Active Comparator group

Description:

iPACK block with ACB + perineural Dexamethasone

Treatment:

Drug: Dexamethasone 4mg

Drug: Dexamethasone 4mg