Clinical trial NCT02570503: Postoperative Pain Control After Periarticular Injection During Total Knee Arthroplasty
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
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: Osteoarthritis, Knee
Lead sponsor: Virginia Commonwealth University
Sponsor class: OTHER
First posted: 2015-10-07
Enrollment: 64
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: Inclusion Criteria:

* Age 18 or older
* Written informed consent

Exclusion Criteria:

* Pregnant women
* Creatinine clearance less than 60 ml/min
* BMI greater than 40
* Currently use greater than 80mg morphine-equivalents daily (pre-operatively)
* Receive a unicondylar knee replacement

Primary outcomes:
measure: Universal Pain Assessment Tool (UPAT)
timeFrame: 3 days after surgery
measure: Narcotic Use During Hospitalization
timeFrame: 0-24 hours post surgery period, 24 - 48 hours post surgery period, and Full 48 hours post surgery period
Secondary outcomes:
measure: Patient's Subjective Rating of Pain
timeFrame: 3 days after surgery
measure: UPAT Score Before and After Physical Therapy
timeFrame: 3 days after surgery
measure: Ambulation During Physical Therapy
timeFrame: 48 hours after surgery
Other outcomes:
Locations:
city: Richmond
country: United States
facility: Virginia Commonwealth University
state: Virginia
Study officials:
affiliation: Virginia Commonwealth University
name: Gregory Golladay, MD
role: PRINCIPAL_INVESTIGATOR
References: