A Phase 4 interventional study of Bupivacaine liposome injectable suspension and Bupivacaine HCl without epinephrine via continuous infusion in Analgesia, sponsored by Heron Therapeutics. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2019-09-26.
Sponsored by Heron Therapeutics · Phase 4, Interventional, and Prevention
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.
Heron Therapeutics is the lead sponsor of 25 studies on the registry; none are open to participants now.
Of its 13 completed or terminated interventional studies of FDA-regulated products, 8 (62%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Liposomal bupivacaine 266 mg via injection
Drug: Bupivacaine liposome injectable suspension
Bupivacaine HCl 300 mg via continuous infusion
Drug: Bupivacaine HCl without epinephrine via continuous infusion
Liposomal bupivacaine 266 mg via injection
Bupivacaine HCl 300 mg via continuous infusion
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
This study is completed, as verified in Sep 2019. You cannot join it, but the record below documents what was studied.
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Heron Therapeutics