Ignite Creation Date:
2025-12-25 @ 1:08 AM
Ignite Modification Date:
2025-12-25 @ 11:20 PM
Study NCT ID:
NCT01042093
Status:
COMPLETED
Last Update Posted:
2013-11-08
First Post:
2010-01-04
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Efficacy of Multimodal Perioperative Analgesia With Periarticular Drug Injection in Total Knee Arthroplasty(TKA)
Sponsor:
Towson Orthopaedic Associates
Organization:
Study Overview
Official Title:
Efficacy of Multimodal Perioperative Analgesia Protocol With Periarticular Drug Injection in Total Knee Arthroplasty: A Randomized, Double Blind Study
Status:
COMPLETED
Status Verified Date:
2013-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
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
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
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: