Postoperative Pain Control After Periarticular Injection During Total Knee Arthroplasty

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Osteoarthritis, Knee

Intervention / Treatment
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* Drug: Ropivacaine
* Drug: Ketorolac
* Drug: Clonidine
* Drug: Epinephrine
* Drug: 0.9% sodium chloride


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: ROP/KET/CLON/EPI/SAL<br>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 | Drug: Ropivacaine<br>* Ropivacaine (5mg/ml)-50ml<br>* Other names: periarticular injection;Drug: Ketorolac<br>* ketorolac (30mg/ml)- 1 ml<br>* Other names: periarticular injection;Drug: Clonidine<br>* clonidine (0.1mg/ml)- 0.8ml<br>* Other names: periarticular injection;Drug: Epinephrine<br>* epinephrine (1mg/ml)-1ml<br>* Other names: periarticular injection;Drug: 0.9% sodium chloride<br>* Sodium chloride 0.9%- 47.7 ml<br>* Other names: periarticular injection;|
| Placebo Comparator: Placebo<br>0.9% Sodium Chloride- 100ml | Drug: 0.9% sodium chloride<br>* Sodium chloride 0.9%- 47.7 ml<br>* Other names: periarticular injection;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 3 days after 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. | 0-24 hours post surgery period, 24 - 48 hours post surgery period, and Full 48 hours post surgery period | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient's Subjective Rating of Pain | Patients are asked if their pain is acceptable (yes/no) | 3 days after surgery | 
| UPAT Score Before and After Physical Therapy | Pain in score change after physical therapy | 3 days after surgery | 
| Ambulation During Physical Therapy | The length (in feet) patient is able to ambulate during physical therapy | 48 hours after surgery |