At a glance
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A Placebo-controlled, Double-blinded, Randomized Pilot Study of Bupivacaine Liposome Injectable Suspension (EXPAREL) for Minimally Invasive Supracervical Hysterectomies Postsurgical Analgesia
In Brief
A Phase 4 clinical trial evaluating Saline Solution for Injection and Exparel for Pain. Completed, enrolled 60 participants across 1 site.
Detailed Summary
The aim of the of the study is a reduction in minimally invasive supracervical hysterectomy postsurgical pain, which may result in less need for supplemental opioid pain medications, fewer opioid related adverse events, and a better recovery experience for patients, which may offer an economic benefit to health care systems. Intracervical preoperative dose of Exparel during minimally invasive (robotic--assisted or traditional laparoscopy) supracervical hysterectomy reduces cumulative pain scores for up to 24 hours and reduces overall requests for break through (additional) analgesia with opioid consumption compared with placebo.
Study Details
Timeline
Interventions
Injection of 20mL of 0.9%Normal Saline
Exparel (bupivacaine liposome injectable suspension) is a liposome injection of bupivacaine, an amide-type local anesthetic, indicated (bupivacaine liposome injectable suspension) for administration into the surgical site to produce postsurgical analgesia.