Postoperative Pain Control After Periarticular Injection During Total Knee Arthroplasty

March 2, 2022 updated by: Virginia Commonwealth University

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

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

64

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Virginia
      • Richmond, Virginia, United States, 23298
        • Virginia Commonwealth University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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
Drug: Ropivacaine
Ropivacaine (5mg/ml)-50ml
Other Names:
  • periarticular injection
Drug: Ketorolac
ketorolac (30mg/ml)- 1 ml
Other Names:
  • periarticular injection
Drug: Clonidine
clonidine (0.1mg/ml)- 0.8ml
Other Names:
  • periarticular injection
Drug: Epinephrine
epinephrine (1mg/ml)-1ml
Other Names:
  • periarticular injection
Drug: 0.9% sodium chloride
Sodium chloride 0.9%- 47.7 ml
Other Names:
  • periarticular injection
Placebo Comparator: Placebo
0.9% Sodium Chloride- 100ml
Drug: 0.9% sodium chloride
Sodium chloride 0.9%- 47.7 ml
Other Names:
  • periarticular injection

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Universal Pain Assessment Tool (UPAT)
Time Frame: 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.
3 days after surgery
Narcotic Use During Hospitalization
Time Frame: 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.
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
Time Frame: 3 days after surgery
Patients are asked if their pain is acceptable (yes/no)
3 days after surgery
UPAT Score Before and After Physical Therapy
Time Frame: 3 days after surgery
Pain in score change after physical therapy
3 days after surgery
Ambulation During Physical Therapy
Time Frame: 48 hours after surgery
The length (in feet) patient is able to ambulate during physical therapy
48 hours after surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Virginia Commonwealth University

Investigators

  • Principal Investigator: Gregory Golladay, MD, Virginia Commonwealth University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2015

Primary Completion (Actual)

February 11, 2021

Study Completion (Actual)

February 11, 2021

Study Registration Dates

First Submitted

October 5, 2015

First Submitted That Met QC Criteria

October 5, 2015

First Posted (Estimate)

October 7, 2015

Study Record Updates

Last Update Posted (Actual)

March 4, 2022

Last Update Submitted That Met QC Criteria

March 2, 2022

Last Verified

March 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HM20004125

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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