IPACK Block in Total Knee Arthroplasty

NCT ID: NCT03692858

Last Updated: 2019-10-22

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

UNKNOWN

Clinical Phase

PHASE2

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-10-01

Study Completion Date

2020-07-31

Brief Summary

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100 patients ASA I-III, undergoing total knee arthroplasty under spinal anesthesia, will be randomly assigned into one of two groups, namely group A (n=50), where an adductor canal block and an IPACK block will be performed preoperatively and group B (n=50) where an adductor canal block only will be performed preoperatively. All patients will receive a standardized multimodal approach, including pregabalin, paracetamol, and PCA with morphine. NRS scores in static and dynamic conditions during the first 48 hours postoperatively, morphine consumption during the first 24 hours postoperatively will be measured and additionally, patient satisfaction, complications, range of knee motion, moblization, functionality, delirium ocurence will be recorded. Chronic pain will be assessed in 3 and 6 months postoperatively.

Detailed Description

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Conditions

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Total Knee Arthroplasty

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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Group A

Group Type ACTIVE_COMPARATOR

Adductor Canal Block plus IPACK Block

Intervention Type DRUG

Adductor Canal Block plus IPACK Block using Ropivacaine

Group B

Group Type ACTIVE_COMPARATOR

Adductor Canal Block

Intervention Type DRUG

Adductor Canal Block using Ropivacaine

Interventions

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Adductor Canal Block plus IPACK Block

Adductor Canal Block plus IPACK Block using Ropivacaine

Intervention Type DRUG

Adductor Canal Block

Adductor Canal Block using Ropivacaine

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Physical status according to American Society of Anesthesiologists (ASA) I-III
* Patients scheduled for total knee arthroplasty

Exclusion Criteria

* Previous operation on same knee
* Contraindication of spinal anesthesia, peripheral nerve blocks or any of the agents used in the protocol
* BMI above 32
* Serious psychiatric, mental and cognitive disorders
* Language barrier
* Block failure
* Chronic opioid, gabapentinoid use
* Severe kidney disfunction
Minimum Eligible Age

14 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Aikaterini Kalampokini

UNKNOWN

Sponsor Role collaborator

Chryssoula Staikou

UNKNOWN

Sponsor Role collaborator

Asklepieion Voulas General Hospital

OTHER_GOV

Sponsor Role lead

Responsible Party

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Alexandros Makris

Consultant Anesthesiologist

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Asklepieion Hospital of Voula

Athens, , Greece

Site Status RECRUITING

Countries

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Greece

Central Contacts

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Alexandros Makris

Role: CONTACT

+306947076446

Facility Contacts

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Alexandros Makris, Dr

Role: primary

Other Identifiers

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8885/20-06-2018

Identifier Type: -

Identifier Source: org_study_id

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