NCT02274870

Liposomal Bupivacaine for Post Operative Pain After Knee Replacement Surgery

Liposomal Bupivacaine for Total Knee Arthroplasty Postoperative Analgesia

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 65 (actual)
• Sponsor: Northwell Health · Academic / Other
• Sex: All
• Age: 18 Years – 74 Years
• Healthy volunteers: Not accepted

Summary

Continuous femoral nerve blocks (CFNB) provide effective pain control to patients undergoing total knee replacement (TKR). However the resulting motor blockade can lead to decreased quadriceps muscle strength and delayed functional recovery.The purpose of this study is to compare the effect of Liposome Bupivacaine infiltration into the knee to CFNB on pain control and functional recovery

Detailed description

This is a prospective, randomized, active controlled study in patients undergoing total knee replacement. The objective of this study is to compare the efficacy of Liposome Bupivacaine, in managing postoperative pain, to standard of care CFNB. Following informed consent, patients will be randomized to one of two groups, Liposome Bupivacaine or active control, CFNB group. 266 mg Liposome Bupivacaine plus Bupivicaine HCL (150mg) will be administered via local joint infiltration around the knee joint prior to wound closure. In the control group a CFNB will be placed for 48hrs prior to surgery. Outcomes measured included pain at rest, movement and quadriceps muscle strength on the first and second postoperative day. It is hypothesized that Liposome Bupivacaine will provide effective pain control and improved preservation of quadriceps muscle strength, in comparison to CFNB.

Conditions

• Post-operative Pain

Interventions

Type	Name	Description
DRUG	Liposome Bupivacaine	Administered via local tissue infiltration around the knee joint
DRUG	Bupivacaine HCl	Administered via CFNB

Timeline

• Start date: 2014-11-01
• Primary completion: 2016-12-01
• Completion: 2017-01-01
• First posted: 2014-10-24
• Last updated: 2018-06-14
• Results posted: 2018-06-14

Locations

1 site across 1 country: United States