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Pain Levels and Opioid Usage in Three Nerve Block Cohorts in Primary TKA

NCT ID: NCT04292392

Last Updated: 2020-11-04

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WITHDRAWN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

2020-04-06

Study Completion Date

2020-09-30

Brief Summary

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The primary objective of this study is to compare effect of combined block of ACB (adductor canal block) with IPACK (Interspace between the Popliteal Artery and the Capsule of the posterior Knee) block and/or Intra-articular block in immediate postoperative and early postop rehabilitation and pain management in patients undergoing primary TKA. The secondary objective is to review both in-hospital and post-discharge pain levels and narcotic usage of primary TKAs, with a minimum 6-week postoperative follow-up.

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 + Periarticular Block

Group A: patient will receive a preop ACB, followed by Intra-articular block during TKA surgery

Group Type EXPERIMENTAL

preop ACB, followed by Intra-articular block during TKA surgery

Intervention Type OTHER

Preoperative ACB (adductor canal block), followed by a local anesthetic injection during surgery, 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 Block

Group B: patient will receive a preop ACB+IPACK block before TKA surgery only

Group Type EXPERIMENTAL

preop ACB+IPACK block

Intervention Type OTHER

Preoperative ACB (adductor canal block) and IPACK (Interspace between the Popliteal Artery and the Capsule of the posterior Knee) block

C - ACB + IPACK + Periarticular Block

Group C: patient will receive a preop ACB+IPACK block, followed by Intra-articular block during TKA surgery

Group Type EXPERIMENTAL

preop ACB+IPACK block, followed by Intra-articular block during TKA surgery

Intervention Type OTHER

Preoperative ACB (adductor canal block) and IPACK (Interspace between the Popliteal Artery and the Capsule of the posterior Knee) block, followed by a local anesthetic injection during surgery, 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

Interventions

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preop ACB, followed by Intra-articular block during TKA surgery

Preoperative ACB (adductor canal block), followed by a local anesthetic injection during surgery, 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

preop ACB+IPACK block

Preoperative ACB (adductor canal block) and IPACK (Interspace between the Popliteal Artery and the Capsule of the posterior Knee) block

Intervention Type OTHER

preop ACB+IPACK block, followed by Intra-articular block during TKA surgery

Preoperative ACB (adductor canal block) and IPACK (Interspace between the Popliteal Artery and the Capsule of the posterior Knee) block, followed by a local anesthetic injection during surgery, 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

Eligibility Criteria

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Inclusion Criteria

1. Patient is indicated for a primary, unilateral TKA secondary to osteoarthritis.
2. Patient age is 22-89 at time of TKA surgery.
3. Patient agrees to participate as a study subject and signs the Informed Consent and Research Authorization document.
4. Patient is able to read and speak English.

Exclusion Criteria

1. Patient is under the age of 22 or over the age of 89.
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

22 Years

Maximum Eligible Age

89 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, Dept. of Orthopaedic Surgery

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Arthur L 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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20.0132

Identifier Type: -

Identifier Source: org_study_id