Postoperative Pain Control After Periarticular Injection During Total Knee Arthroplasty

Phase 4

Terminated

• Conditions: Osteoarthritis, Knee
• Interventions: Drug: 0.9% sodium chloride; Drug: Ropivacaine; Drug: Ketorolac; Drug: Clonidine; Drug: Epinephrine

• Registration Number: NCT02570503
• Lead Sponsor: Virginia Commonwealth University

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.

Study Timeline

• Study Start: 2015-10
• Study First Submitted: 2015-10-05
• Study First Submitted QC: 2015-10-05
• Study First Posted: 2015-10-07
• Primary Completion: 2021-02-11
• Study Completion: 2021-02-11
• Results First Submitted: 2022-02-08
• Status Verified: 2022-03
• Results First Submitted QC: 2022-03-02
• Last Update Submitted: 2022-03-02
• Results First Posted: 2022-03-04
• Last Update Posted: 2022-03-04

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 64

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	0.9% sodium chloride	0.9% Sodium Chloride- 100ml
ROP/KET/CLON/EPI/SAL	0.9% sodium chloride	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
ROP/KET/CLON/EPI/SAL	Ropivacaine	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
ROP/KET/CLON/EPI/SAL	Ketorolac	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
ROP/KET/CLON/EPI/SAL	Clonidine	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
ROP/KET/CLON/EPI/SAL	Epinephrine	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

Primary Outcome Measures

Name	Time	Method
Universal Pain Assessment Tool (UPAT)	3 days after surgery	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	0-24 hours post surgery period, 24 - 48 hours post surgery period, and Full 48 hours post surgery period	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

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

Trial Locations

Locations (1)

Virginia Commonwealth University; 🇺🇸 Richmond, Virginia, United States