Postoperative Pain Control After Periarticular Injection During Total Knee Arthroplasty
Primary Purpose
Osteoarthritis, Knee
Status
Terminated
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Ropivacaine
Ketorolac
Clonidine
Epinephrine
0.9% sodium chloride
Sponsored by
About this trial
This is an interventional treatment trial for Osteoarthritis, Knee
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
Sites / Locations
- Virginia Commonwealth University
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
ROP/KET/CLON/EPI/SAL
Placebo
Arm Description
Ropivacaine (ROP) (5mg/ml)- 50ml Ketorolac (KET) (30mg/ml)- 1ml Clonidine (CLON) (0.1mg/ml)- 0.8ml Epinephrine (EPI) (1mg/ml)- 0.5ml 0.9% sodium chloride SAL)--47.7 ml
0.9% Sodium Chloride- 100ml
Outcomes
Primary Outcome Measures
Universal Pain Assessment Tool (UPAT)
Patient's pain scores will be measured with the UPAT scale which ranges from 0 (no pain) to 10 (severe pain) This is measured hourly while the patient is awake after the surgery.
Narcotic Use During Hospitalization
The amount of narcotic pain medication needed for patient to be comfortable. This is measured in morphine equivalents since there are many pain medications other than morphine.
Secondary Outcome Measures
Patient's Subjective Rating of Pain
Patients are asked if their pain is acceptable (yes/no)
UPAT Score Before and After Physical Therapy
Pain in score change after physical therapy
Ambulation During Physical Therapy
The length (in feet) patient is able to ambulate during physical therapy
Full Information
NCT ID
NCT02570503
First Posted
October 5, 2015
Last Updated
March 2, 2022
Sponsor
Virginia Commonwealth University
1. Study Identification
Unique Protocol Identification Number
NCT02570503
Brief Title
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
2. Study Status
Record Verification Date
March 2022
Overall Recruitment Status
Terminated
Why Stopped
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.
Study Start Date
October 2015 (undefined)
Primary Completion Date
February 11, 2021 (Actual)
Study Completion Date
February 11, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Virginia Commonwealth University
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteoarthritis, Knee
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
64 (Actual)
8. Arms, Groups, and Interventions
Arm Title
ROP/KET/CLON/EPI/SAL
Arm Type
Experimental
Arm Description
Ropivacaine (ROP) (5mg/ml)- 50ml Ketorolac (KET) (30mg/ml)- 1ml Clonidine (CLON) (0.1mg/ml)- 0.8ml Epinephrine (EPI) (1mg/ml)- 0.5ml 0.9% sodium chloride SAL)--47.7 ml
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
0.9% Sodium Chloride- 100ml
Intervention Type
Drug
Intervention Name(s)
Ropivacaine
Other Intervention Name(s)
periarticular injection
Intervention Description
Ropivacaine (5mg/ml)-50ml
Intervention Type
Drug
Intervention Name(s)
Ketorolac
Other Intervention Name(s)
periarticular injection
Intervention Description
ketorolac (30mg/ml)- 1 ml
Intervention Type
Drug
Intervention Name(s)
Clonidine
Other Intervention Name(s)
periarticular injection
Intervention Description
clonidine (0.1mg/ml)- 0.8ml
Intervention Type
Drug
Intervention Name(s)
Epinephrine
Other Intervention Name(s)
periarticular injection
Intervention Description
epinephrine (1mg/ml)-1ml
Intervention Type
Drug
Intervention Name(s)
0.9% sodium chloride
Other Intervention Name(s)
periarticular injection
Intervention Description
Sodium chloride 0.9%- 47.7 ml
Primary Outcome Measure Information:
Title
Universal Pain Assessment Tool (UPAT)
Description
Patient's pain scores will be measured with the UPAT scale which ranges from 0 (no pain) to 10 (severe pain) This is measured hourly while the patient is awake after the surgery.
Time Frame
3 days after surgery
Title
Narcotic Use During Hospitalization
Description
The amount of narcotic pain medication needed for patient to be comfortable. This is measured in morphine equivalents since there are many pain medications other than morphine.
Time Frame
0-24 hours post surgery period, 24 - 48 hours post surgery period, and Full 48 hours post surgery period
Secondary Outcome Measure Information:
Title
Patient's Subjective Rating of Pain
Description
Patients are asked if their pain is acceptable (yes/no)
Time Frame
3 days after surgery
Title
UPAT Score Before and After Physical Therapy
Description
Pain in score change after physical therapy
Time Frame
3 days after surgery
Title
Ambulation During Physical Therapy
Description
The length (in feet) patient is able to ambulate during physical therapy
Time Frame
48 hours after surgery
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gregory Golladay, MD
Organizational Affiliation
Virginia Commonwealth University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Virginia Commonwealth University
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23298
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Postoperative Pain Control After Periarticular Injection During Total Knee Arthroplasty
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