Liposomal Bupivacaine in Total Knee Arthroplasty

Osteoarthritis Clinical Trial

Official title:

Analgesic Efficacy of Liposomal Bupivacaine in Total Knee Arthroplasty

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02426164
• Other study ID #: 633913
• Status: Not yet recruiting
• Phase: Phase 4
• First received: April 14, 2015
• Last updated: April 21, 2015
• Start date: June 2015
• Est. completion date: June 2017

Study information

• Verified date: April 2015
• Source: Miller Orthopedic Specialists
• Contact: Leslie Centeno
• Phone: 712-388-0144
• Email: Lcenteno[@]millerortho.com
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

Liposomal bupivacaine is a novel local anesthetic designed for prolonged pain relief. Despite its long-acting analgesic potential, liposomal bupivacaine is significantly more expensive than other local anesthetic alternatives. The primary aim of this investigation is to examine whether or not liposomal bupivacaine provides superior pain relief or clinically significant opioid-sparing effects versus a control to justify its cost.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 170
• Est. completion date: June 2017
• Est. primary completion date: June 2017
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 90 Years

Eligibility

Inclusion Criteria:

• Patients undergoing a primary unilateral total knee arthroplasty by the PI of the trial

Exclusion Criteria:

• Patients with a sensitivity to marcaine

• Pregnant or lactating women

• Non-English speaking individuals

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Arthroplasty, Replacement, Knee
• Osteoarthritis
• Pain, Postoperative

Intervention

Drug:
• Liposomal bupivacaine
Periarticular infiltration of the liposomal bupivacaine with 20cc of normal saline
• bupivacaine HCl, morphine, epinephrine, methylprednisolone
Periarticular infiltration of 24c of bupivacaine HCl, 0.8cc morphine, 0.3cc epinephrine, and 1cc of methylprednisolone

Locations

Country	Name	City	State
United States	Miller Orthopedic Specialists	Council Bluffs	Iowa

Sponsors (3)

Lead Sponsor	Collaborator
Miller Orthopedic Specialists	CHI Health Mercy Hospital, Creighton University Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mean visual analog scale (VAS) pain scores	Self-reported pain scores from 0=no pain to 10=severe pain	Night of surgery	No
Primary	Mean visual analog scale (VAS) pain scores	Self-reported pain scores from 0=no pain to 10=severe pain	Post-operative day 1	No
Primary	Mean visual analog scale (VAS) pain scores	Self-reported pain scores from 0=no pain to 10=severe pain	Post-operative day 2	No
Primary	Pain assessment phone call	Subjects will be called on post-operative day three by one of the investigators of the study. Subjects will be asked to rate their current pain level from 1 to 10 and to rate their worst pain level from 1 to 10 that day.	Post-operative day 3	No
Secondary	Complications	Number of patients with complications	Complications will be followed for the duration of patients' hospital stay, an expected average of 2-3 days.	Yes