ACB + IPACK Block With or Without Local Infiltration in RA-TKA

NCT ID: NCT03840122

Last Updated: 2019-10-10

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

WITHDRAWN

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Study Start Date

2019-10-08

Study Completion Date

2019-10-08

Brief Summary

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The purpose of this study is to compare the outcomes of an Adductor canal block (ACB) + interspace between the popliteal artery and the capsule of the knee (IPACK) block along with a single intraoperative injection of a standard local anesthetic that includes Ropivacaine, Epinephrine, Ketorolac, Clonidine and saline to an ACB + IPACK block without the intraoperative injection of a standard local anesthetic in patients undergoing Robotic Arm-Assisted TKA (RA-TKA).

Detailed Description

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Conditions

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Knee Arthropathy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

SINGLE

Participants

Study Groups

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A - ACB + IPACK with injection

50 arms: ACB + IPACK block with injection of local anesthetic of Ropivacaine, Epinephrine, Ketorolac, Clonidine and saline

Group Type EXPERIMENTAL

ACB + IPACK block with injection of local anesthetic

Intervention Type OTHER

ACB + IPACK block with injection of local anesthetic which is comprised of the following agents and amounts:

* Ropivacaine 5mg/ml (49.25ml)
* Epinephrine 1mg/ml (0.5ml)
* Ketorolac 30mg/ml (1ml)
* Clonidine 0.1mg/ml (0.8ml)
* Saline 48.45ml

B - ACB + IPACK without injection

50 arms: ACB + IPACK block without injection of local anesthetic

Group Type ACTIVE_COMPARATOR

ACB + IPACK block without injection

Intervention Type OTHER

ACB + IPACK block without an injection of local anesthetic

Interventions

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ACB + IPACK block with injection of local anesthetic

ACB + IPACK block with injection of local anesthetic which is comprised of the following agents and amounts:

* Ropivacaine 5mg/ml (49.25ml)
* Epinephrine 1mg/ml (0.5ml)
* Ketorolac 30mg/ml (1ml)
* Clonidine 0.1mg/ml (0.8ml)
* Saline 48.45ml

Intervention Type OTHER

ACB + IPACK block without injection

ACB + IPACK block without an injection of local anesthetic

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

1. Patient is over the age of 21
2. Patient is scheduled to undergo a unilateral, primary TKA, secondary to osteoarthritis
3. Patient agrees to participate as a study subject and signs the Informed Consent and Research Authorization documents
4. Patient is able to read and speak English.

Exclusion Criteria

1. Patient is under the age of 21
2. Patient's primary diagnosis is not osteoarthritis (e.g. post-traumatic arthritis)
3. Patient is scheduled to undergo a bilateral TKA surgery
4. Patient is unable to read and speak English
Minimum Eligible Age

21 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Louisville

OTHER

Sponsor Role lead

Responsible Party

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Arthur Malkani

Professor, Adult Reconstruction

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Arthur Malkani, MD

Role: PRINCIPAL_INVESTIGATOR

University of Louisville

Locations

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Jewish Hospital

Louisville, Kentucky, United States

Site Status

Countries

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United States

Other Identifiers

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18.1246

Identifier Type: -

Identifier Source: org_study_id

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