Liposomal Bupivacaine in Total Knee Arthroplasty

Knee Osteoarthritis Clinical Trial

Official title:

Efficacy of Regional Adductor Canal Block Using Extended Release Liposomal Bupivacaine in Total Knee Arthroplasty: A Randomized Prospective Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03541265
• Other study ID #: 04141603
• Status: Completed
• Phase: N/A
• Start date: May 1, 2016
• Est. completion date: March 1, 2018

Study information

• Verified date: May 2018
• Source: Bronx-Lebanon Hospital Center Health Care System
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Pain management after total knee arthroplasty is essential for optimized clinical outcomes and higher satisfaction. Exparel (Pacira Pharmaceuticals, Parsippany, New Jersey, USA) is a long-acting Bupivacaine extended release liposome compound that is injected peri-articularly or as regional block. The purpose of this study was to compare the analgesic efficacy of single administration of Exparel for local peri-articular infiltration versus adductor canal regional block.

Description:

Multimodal pain approach is now an accepted standard of care to improve pain, enable earlier mobilization and faster recovery, decreased length of stay, and reduce opioid consumption and related side effects. The multimodal approach includes peri-operative oral and IV analgesics, local periarticular injections (PAI), and/or regional blocks such as femoral nerve blocks nerve or subsartorial saphenous nerve (adductor canal) blocks. Extended release bupivacaine (Exparel - Pacira Pharmaceuticals, Parsippany, NJ, USA) in liposomal form was developed for longer lasting post-operative analgesia. There are limited studies analyzing its efficacy of single injection liposomal bupivacaine in adductor canal block in total knee arthroplasty. The investigators hypothesized that a single adductor canal regional block injection would provide similar pain relief as peri-articular infiltration of Exparel.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 70
• Est. completion date: March 1, 2018
• Est. primary completion date: June 1, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 25 Years and older

Eligibility

Inclusion Criteria:

• primary knee osteoarthritis undergoing unilateral knee replacement

Exclusion Criteria:

• hypersensitivity and/or allergies to local anesthetics or previous knee surgery

Related Conditions & MeSH terms

• Anesthesia, Local
• Knee Osteoarthritis
• Osteoarthritis
• Osteoarthritis, Knee

Intervention

Drug:
• Exparel
long-acting Bupivacaine extended release liposome compound

Procedure:
• Adductor block protocol
Adductor block using Exparel
• peri-articular injection protocol
peri-articular injection using Exparel

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Bronx-Lebanon Hospital Center Health Care System

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Difference in mean pain scores in the first 3 days after surgery	Pain was recorded during the first 3 post-operative days after surgery on scale 0 to 10 (visual analog scale). Zero represents 'no pain', as the best outcome and 10 represents as 'the worst pain experienced' as the worst outcome.The difference between the mean pain score in the two groups is assessed.	3 days
Secondary	Difference in mean opioid consumption in the first 3 days after surgery	All opioids were converted to Morphine equivalent consumption (MEC) during the first 3 days. The difference in the mean MEC in the two groups is assessed.	3 days