Franklin
Valley Stream, New York, 11580, United States
NCT Number: NCT02274870
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
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Notify Me18 year–74 year
All sexes
Interventional
Phase 4
Valley Stream, New York, 11580, United States
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Administered via local tissue infiltration around the knee joint
Other names: Bupivacaine Liposome, Injectable Suspension
Administered via CFNB
Other names: Standard of Care
Time frame: 24hrs
Pain intensity at maximum knee flexion measured using a 0-10 visual analog scale.
Higher values represent a higher pain intensity or worse outcome.
Time frame: 24hrs
Pain intensity at maximum knee flexion measured using a 0-10 visual analog scale.
Higher values represent a higher pain intensity or worse outcome.
Time frame: 24hrs
Time frame: 72hrs
Time frame: 48hrs
Time frame: 24hrs
Time frame: 12hrs
Time frame: 4hrs
Time frame: 2hrs
Time frame: Baseline
Northwell Health
Other
Liposomal Bupivacaine for Total Knee Arthroplasty Postoperative Analgesia
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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