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

NCT ID: NCT07180953

Last Updated: 2025-09-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE4

Total Enrollment

90 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-09-01

Study Completion Date

2025-10-30

Brief Summary

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"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

Detailed Description

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Conditions

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Osteoarthritis, Knee Knee Pain Chronic Arthropathy of Knee

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Control

iPACK block with ACB

Group Type PLACEBO_COMPARATOR

NaCl 0.9%

Intervention Type DRUG

iPACK block with Adductor Canal Block (2 x 20ml 0.2% ropivacaine + 1ml 0.9% NaCl) + 2ml 0.9% NaCl iv

iv DEX

iPACK block with ACB + iv Dexamethasone

Group Type ACTIVE_COMPARATOR

Dexamethasone 4mg

Intervention Type DRUG

iPACK block with Adductor Canal Block (2 x 20ml 0.2% ropivacaine + 1ml 0.9% NaCl) + 4mg Dexamethasone iv

pn DEX

iPACK block with ACB + perineural Dexamethasone

Group Type ACTIVE_COMPARATOR

Dexamethasone 4mg

Intervention Type DRUG

iPACK block with Adductor Canal Block (2 x 20ml 0.2% ropivacaine + 2mg Dexamethasone) + 2ml 0.9% NaCl iv

Interventions

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NaCl 0.9%

iPACK block with Adductor Canal Block (2 x 20ml 0.2% ropivacaine + 1ml 0.9% NaCl) + 2ml 0.9% NaCl iv

Intervention Type DRUG

Dexamethasone 4mg

iPACK block with Adductor Canal Block (2 x 20ml 0.2% ropivacaine + 1ml 0.9% NaCl) + 4mg Dexamethasone iv

Intervention Type DRUG

Dexamethasone 4mg

iPACK block with Adductor Canal Block (2 x 20ml 0.2% ropivacaine + 2mg Dexamethasone) + 2ml 0.9% NaCl iv

Intervention Type DRUG

Other Intervention Names

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iv Dexamethasone

Eligibility Criteria

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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.
Minimum Eligible Age

65 Years

Maximum Eligible Age

100 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Poznan University of Medical Sciences

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Poznan University of Medical Sciences

Poznan, , Poland

Site Status RECRUITING

Countries

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Poland

Central Contacts

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Malgorzata Reysner, MD PhD

Role: CONTACT

+48618738303

Grzegorz Kowalski, MD PhD

Role: CONTACT

+48618738313

Facility Contacts

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Malgorzata Reysner, M.D. Ph.D.

Role: primary

+48 61 873 83 03

Other Identifiers

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02/20025

Identifier Type: -

Identifier Source: org_study_id

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