Who is sponsoring NCT02570503?

NCT02570503 is sponsored by Virginia Commonwealth University.

What condition does NCT02570503 study?

NCT02570503 studies Osteoarthritis, Knee.

What drugs are being tested in NCT02570503?

Interventions: Ropivacaine, Ketorolac, Clonidine, Epinephrine, 0.9% sodium chloride.

What is the status of NCT02570503?

NCT02570503 is currently TERMINATED.

Last reviewed 2022-03-02 · How we verify

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

NCT02570503 Phase 4 TERMINATED Results posted

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.

Details

Lead sponsor	Virginia Commonwealth University
Phase	Phase 4
Status	TERMINATED
Enrolment	64
Start date	2015-10
Completion	2021-02-11

Conditions

Osteoarthritis, Knee

Interventions

Ropivacaine
Ketorolac
Clonidine
Epinephrine
0.9% sodium chloride

Primary outcomes

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.

Countries

United States