ESPB vs iPACK+ACB in Total Knee Arthroplasty

NCT ID: NCT06302218

Last Updated: 2024-03-08

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

NOT_YET_RECRUITING

Clinical Phase

PHASE4

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-04-01

Study Completion Date

2025-10-30

Brief Summary

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Effect of iPACK block with Adductor Canal Block and ESPB on pain management, and NLR and PLR following knee arthroplasty

Detailed Description

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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 surgery's induced stress response, opioid consumption, and opioid-related side effects.

In recent years, the influence of regional anesthesiology on reducing the inflammatory response after surgical procedures has been emphasised. However, very few studies have evaluated the effect of various methods of anaesthesia on the NLR and PLR.

This is the first study to investigate the effect of regional anaesthesia on the pain managementonse expres and stress respsed by the NLR and PLR in patients undergoing knee replacement surgery.

Conditions

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Knee Arthritis Knee Arthropathy Knee Osteoarthritis Knee Pain Chronic Knee Disease Knee Rheumatism

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Outcome Assessors

Study Groups

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iPACK + ACB

spinal anesthesia

\+ ultrasound guided iPACK (20ml 0,2% ropivacaine) with ACB (10ml 0.5% ropivacaine)

Group Type ACTIVE_COMPARATOR

Ropivacaine 0.2% Injectable Solution

Intervention Type DRUG

iPACK block + Adductor Canal Block

Erectro Spinae Plane Block

spinal anesthesia

\+ ultrasound guided ESPBk - 20ml 0,2% ropivacaine

Group Type ACTIVE_COMPARATOR

Ropivacaine 0.2% Injectable Solution

Intervention Type DRUG

Erector Spinae Plane Block

Control group

Only spinal anesthesia - No peripheral nerve block

Group Type PLACEBO_COMPARATOR

control group

Intervention Type DRUG

only spinal anesthesia

Interventions

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Ropivacaine 0.2% Injectable Solution

iPACK block + Adductor Canal Block

Intervention Type DRUG

Ropivacaine 0.2% Injectable Solution

Erector Spinae Plane Block

Intervention Type DRUG

control group

only spinal anesthesia

Intervention Type DRUG

Other Intervention Names

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iPACK + ACB ESPB only spinal anesthesia

Eligibility Criteria

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Inclusion Criteria

* Patients with ASA classification I-III, Aged 20-90 years, Who will be scheduled for knee arthroplasty under spinal anaesthesia.

Exclusion Criteria

* patients who have a history of bleeding diathesis,
* take anticoagulant therapy,
* have a History of chronic pain before surgery,
* have Multiple trauma, cannot assess their pain (dementia),
* have been operated on under general anaesthesia,
* have an infection in the area and do not accept the procedure
Minimum Eligible Age

18 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

Principal Investigators

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Łukasz Łapaj, Ph.D.

Role: STUDY_CHAIR

Poznań University of Medical Sciences

Locations

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Poznan University of Medical Sciences

Poznan, Poznań, Poland

Site Status

Countries

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Poland

Central Contacts

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Malgorzata Domagalska, Ph.D.

Role: CONTACT

608762068

Małgorzata Domagalska, Ph.D.

Role: CONTACT

61 873 83 03

Other Identifiers

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5/2024

Identifier Type: -

Identifier Source: org_study_id

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