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Efficacy of Multimodal Perioperative Analgesia With Periarticular Drug Injection in Total Knee Arthroplasty(TKA)

NCT ID: NCT01042093

Last Updated: 2013-11-08

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

160 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-01-31

Study Completion Date

2011-07-31

Brief Summary

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The purpose of this study is to compare different medication combinations used in a periarticular injection after total knee replacement surgery(TKR). A periarticular injection is an injection that is given into the tissues surrounding the knee joint. The injection is given while the patient is still in surgery.

The study will compare the level of pain management, length of hospital stay, range of motion and side effects from subjects receiving one of four different combinations of medication in a periarticular injection. The medications used in the injections are approved medications routinely used for pain management.

Approximately 160 subjects will participate in this study. The surgeon, study personnel, and patients will be blinded to the combination of medications each patient receives. The pharmacist will prepare the 4 different combinations of medications, randomize each patient to the particular combination of medications, and maintain the study drug documentation.

Detailed Description

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Data Collection:

Data will be collected from the patient's pre-operative office visit, up to six weeks post-operatively.

Variables

Pre-operative Collection:

* Vital signs
* Hb/Hct
* Age
* Sex
* BMI
* WOMAC Score - Screen Failure at 36 or 12
* Visual Analog Scale (VAS)

Intra-operative Collection:

* Duration of surgery
* Tourniquet time
* Time of periarticular injection

Post-operative Collection:

* Pain Scores in the inpatient post-anesthesia care unit (PACU) using the 1- to 10- point Visual Analog Scale (VAS) an admission to unit, 1 hour, 2 hour, and on discharge.
* VAS pain scores every 8 hours on the Orthopaedic floor
* Use of supplementary narcotics
* Use of anti-emetics
* Serious Adverse Events (SAE) including deep vein thrombosis (DVT) formation, pulmonary embolism (PE), myocardial infarct or other serious cardiac event, excessive bleeding
* Length of hospital stay
* Requirement for inpatient rehabilitation versus discharge home
* Hours/Days to straight leg raise -POD 1, 2, 3 by MD on rounds.
* Days to independent ambulation
* Hemoglobin and Hematocrit levels on post-operative days one and two
* Presence/Absence of Bowel/Bladder Function

Data to be Collected by Physical Therapist: POD 1, 2, 3, Numerical Rating Scale (NRS) Pain with Ambulation

* Use of Assisted Devices
* Distance walked
* Range of Motion(ROM) (using Goniometer)- active and passive.

Treatment Periods Screening Visit Day 0 - Day of surgery Visit Day 1, 2, 3 (Post-operative days 1, 2, and 3) 6 Week visit in Office

Conditions

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Osteoarthritis,Knee

Keywords

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Analgesia postoperative pain periarticular arthroplasty pain management

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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ROP/EPI/TOR/CLO

Ropivacaine 5mg/ml (49.25 ml) Epinephrine 1 mg/ml (0.5 ml) Toradol 30mg/ml (1 ml) Clonidine 0.1 mg/ml (0.08mg - 0.8 ml)

Group Type ACTIVE_COMPARATOR

Ropivacaine

Intervention Type DRUG

Ropivacaine 5mg/ml (49.25 ml)

Toradol

Intervention Type DRUG

Toradol 30mg/ml (1 ml)

Clonidine

Intervention Type DRUG

Clonidine 0.1 mg/ml (0.08mg - 0.8 ml)

Epinephrine

Intervention Type DRUG

Epinephrine 1 mg/ml (0.5 ml)

ROP/EPI/TOR

Ropivacaine 5mg/ml (49.25 ml) Epinephrine 1 mg/ml (0.5 ml) Toradol 30mg/ml (1 ml)

Group Type ACTIVE_COMPARATOR

Ropivacaine

Intervention Type DRUG

Ropivacaine 5mg/ml (49.25 ml)

Toradol

Intervention Type DRUG

Toradol 30mg/ml (1 ml)

Epinephrine

Intervention Type DRUG

Epinephrine 1 mg/ml (0.5 ml)

ROP/EPI/CLO

Ropivacaine 5mg/ml (49.25 ml) Epinephrine 1 mg/ml (0.5 ml) Clonidine 0.1 mg/ml (0.08mg - 0.8 ml)

Group Type ACTIVE_COMPARATOR

Ropivacaine

Intervention Type DRUG

Ropivacaine 5mg/ml (49.25 ml)

Clonidine

Intervention Type DRUG

Clonidine 0.1 mg/ml (0.08mg - 0.8 ml)

Epinephrine

Intervention Type DRUG

Epinephrine 1 mg/ml (0.5 ml)

ROP/EPI

Ropivacaine 5mg/ml (49.25ml) Epinephrine 1 mg/ml (0.5 ml)

Group Type ACTIVE_COMPARATOR

Ropivacaine

Intervention Type DRUG

Ropivacaine 5mg/ml (49.25 ml)

Epinephrine

Intervention Type DRUG

Epinephrine 1 mg/ml (0.5 ml)

Interventions

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Ropivacaine

Ropivacaine 5mg/ml (49.25 ml)

Intervention Type DRUG

Toradol

Toradol 30mg/ml (1 ml)

Intervention Type DRUG

Clonidine

Clonidine 0.1 mg/ml (0.08mg - 0.8 ml)

Intervention Type DRUG

Epinephrine

Epinephrine 1 mg/ml (0.5 ml)

Intervention Type DRUG

Other Intervention Names

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periarticular injection periarticular injection periarticular injection periarticular injection

Eligibility Criteria

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Inclusion Criteria

1. Men and Women aged 30 to 85 years
2. Voluntary, written informed consent given to participate in this clinical investigation

Exclusion Criteria

1. Pregnant or lactating women
2. Presence of allergies or contraindication to any medications indicated in the study
3. Contraindication to or failure of spinal anesthesia
4. Known drug or alcohol abuse or psychologic disorder that could affect follow-up care or treatment outcomes
5. Patients with a diagnosis of inflammatory arthritis
6. Previous major bone surgery in the operative knee
7. Simultaneous, bilateral TKRs
Minimum Eligible Age

30 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Towson Orthopaedic Associates

OTHER

Sponsor Role lead

Responsible Party

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David F. Dalury, MD

Orthopaedic Surgeon

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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David F. Dalury, MD

Role: PRINCIPAL_INVESTIGATOR

Towson Orthpaedic Associates

Countries

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United States

Other Identifiers

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1113723

Identifier Type: -

Identifier Source: org_study_id