Ignite Creation Date:
2025-12-24 @ 7:48 PM
Ignite Modification Date:
2026-01-07 @ 9:06 AM
Study NCT ID:
NCT02570503
Status:
TERMINATED
Last Update Posted:
2022-03-04
First Post:
2015-10-05
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Postoperative Pain Control After Periarticular Injection During Total Knee Arthroplasty
Sponsor:
Virginia Commonwealth University
Organization:
Study Overview
Official Title:
Do Intraoperative Periarticular Injections Improve Postoperative Pain Control in Patients Receiving Duramorph (Preservative Free) During Total Knee Arthroplasty? A Prospective, Double-Blind, Randomized Controlled Trial
Status:
TERMINATED
Status Verified Date:
2022-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Study's primary aims are no longer clinically impactful, as intrathecal morphine has fallen out of favor and replaced with different agents so that outpatient/23 hr surgery is more predictably achievable.
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This study will evaluate the use of a local injection around the knee (periarticular) during total knee replacement (TKR) surgery to see if it reduces postoperative pain levels. The injection is a combination of various medications which are thought to reduce pain levels.
Approximately 128 patients will participate in this study, half of the patients will receive this injection during surgery and the other half will receive a saline (salt water) injection. Pain scores after the surgery will be compared between the two groups.
All patients will also receive a long-acting (24 hours) morphine injection during surgery.
The hypothesis is that those participants receiving intrathecal Duramorph and local periarticular injections will have improved pain scores and reduced narcotic use when compared with intrathecal Duramorph alone at 48 hours postoperatively.
Approximately 128 patients will participate in this study, half of the patients will receive this injection during surgery and the other half will receive a saline (salt water) injection. Pain scores after the surgery will be compared between the two groups.
All patients will also receive a long-acting (24 hours) morphine injection during surgery.
The hypothesis is that those participants receiving intrathecal Duramorph and local periarticular injections will have improved pain scores and reduced narcotic use when compared with intrathecal Duramorph alone at 48 hours postoperatively.
Detailed Description:
Data Collection:
Data will be collected from the patient's medical record after discharge
Variables include:
* Age
* Sex
* BMI
* UPAT score (Universal Pain Assessment Tool)- this is assessed hourly postoperatively by nursing staff on Orthopedics Unit
* Patient's assessment of acceptability of pain
* UPAT score as assessed by physical therapy pre and post therapy sessions
* Duramorph dose
* Time patient arrived on the Orthopedic Unit
* Length of ambulation during physical therapy sessions
* Amount of supplementary opioids (measured in morphine equivalents)
* Use of anti-emetics
* Any complications of surgery including venous thromboembolic event, cardiac event, bleeding event
* Length of hospital stay
The pharmacist will randomize patients to either study arm, prepare the injection and maintain dispensing records.
Data will be collected from the patient's medical record after discharge
Variables include:
* Age
* Sex
* BMI
* UPAT score (Universal Pain Assessment Tool)- this is assessed hourly postoperatively by nursing staff on Orthopedics Unit
* Patient's assessment of acceptability of pain
* UPAT score as assessed by physical therapy pre and post therapy sessions
* Duramorph dose
* Time patient arrived on the Orthopedic Unit
* Length of ambulation during physical therapy sessions
* Amount of supplementary opioids (measured in morphine equivalents)
* Use of anti-emetics
* Any complications of surgery including venous thromboembolic event, cardiac event, bleeding event
* Length of hospital stay
The pharmacist will randomize patients to either study arm, prepare the injection and maintain dispensing records.
Study Oversight
Has Oversight DMC:
True
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?: