Postoperative Pain Control After Periarticular Injection During Total Knee Arthroplasty
NCT ID: NCT02570503
Last Updated: 2022-03-04
Study Results
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View full resultsBasic Information
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TERMINATED
PHASE4
64 participants
INTERVENTIONAL
2015-10-31
2021-02-11
Brief Summary
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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.
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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ROP/KET/CLON/EPI/SAL
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
Ropivacaine
Ropivacaine (5mg/ml)-50ml
Ketorolac
ketorolac (30mg/ml)- 1 ml
Clonidine
clonidine (0.1mg/ml)- 0.8ml
Epinephrine
epinephrine (1mg/ml)-1ml
0.9% sodium chloride
Sodium chloride 0.9%- 47.7 ml
Placebo
0.9% Sodium Chloride- 100ml
0.9% sodium chloride
Sodium chloride 0.9%- 47.7 ml
Interventions
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Ropivacaine
Ropivacaine (5mg/ml)-50ml
Ketorolac
ketorolac (30mg/ml)- 1 ml
Clonidine
clonidine (0.1mg/ml)- 0.8ml
Epinephrine
epinephrine (1mg/ml)-1ml
0.9% sodium chloride
Sodium chloride 0.9%- 47.7 ml
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Written informed consent
Exclusion Criteria
* 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
18 Years
ALL
Yes
Sponsors
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Virginia Commonwealth University
OTHER
Responsible Party
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Principal Investigators
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Gregory Golladay, MD
Role: PRINCIPAL_INVESTIGATOR
Virginia Commonwealth University
Locations
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Virginia Commonwealth University
Richmond, Virginia, United States
Countries
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Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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HM20004125
Identifier Type: -
Identifier Source: org_study_id
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