Postoperative Pain Control After Periarticular Injection During Total Knee Arthroplasty

Osteoarthritis, Knee Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02570503
• Other study ID #: HM20004125
• Status: Terminated
• Phase: Phase 4
• Start date: October 2015
• Est. completion date: February 11, 2021

Study information

• Verified date: March 2022
• Source: Virginia Commonwealth University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 64
• Est. completion date: February 11, 2021
• Est. primary completion date: February 11, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Osteoarthritis, Knee
• Pain, Postoperative

Intervention

Drug:
• 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

Locations

Country	Name	City	State
United States	Virginia Commonwealth University	Richmond	Virginia

Sponsors (1)

Lead Sponsor	Collaborator
Virginia Commonwealth University

Country where clinical trial is conducted

United States, 

Outcome

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