Clinical trial NCT01042093: Efficacy of Multimodal Perioperative Analgesia With Periarticular Drug Injection in Total Knee Arthroplasty(TKA)
Official title: Efficacy of Multimodal Perioperative Analgesia Protocol With Periarticular Drug Injection in Total Knee Arthroplasty: A Randomized, Double Blind Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Osteoarthritis,Knee
Keywords: Analgesia
postoperative pain
periarticular
arthroplasty
pain management
Lead sponsor: Towson Orthopaedic Associates
Sponsor class: OTHER
First posted: 2010-01-05
Enrollment: 160
Sex: ALL
Minimum age (years): 30
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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: 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

Eligibility criteria: 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

Primary outcomes:
measure: Numerical Rating Scale (NRS) Pain Scores During Hospitalization.
timeFrame: 2 days after surgery
Secondary outcomes:
measure: Narcotic Consumption During Hospitalization
timeFrame: 4 days
measure: Knee Society Pain Scores at 6 Week Follow-up Appointment
timeFrame: 6 weeks after surgery
Other outcomes:
Locations:
Study officials:
affiliation: Towson Orthpaedic Associates
name: David F. Dalury, MD
role: PRINCIPAL_INVESTIGATOR
References: