This is a phase 4, randomized, open-label study of the efficacy, safety, and pharmacokinetics of bupivacaine administered as liposomal bupivacaine or continuous infusion via elastomeric pump following unilateral open inguinal herniorrhaphy.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
32
Liposomal bupivacaine 266 mg via injection
Bupivacaine HCl 300 mg via continuous infusion
Anaheim Clinical Trials, LLC
Anaheim, California, United States
Mean area under the curve (AUC) of the Numeric Rating Scale of pain intensity scores with activity (NRS-A) through 72 hours (AUC0-72)
Time frame: 72 hours
Total postoperative opioid consumption (in morphine equivalents)
Time frame: 72 hours
Proportion of subjects who are opioid-free
Time frame: 72 hours
Median time in hours to first opioid rescue medication
Time frame: 72 hours
Mean AUC0-72 of the NRS-R pain intensity scores.
Time frame: 72 hours
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