NCT02104414

Efficacy of Rectal Infiltration of Exparel for Analgesic Benefit Following Hemorrhoidectomy

Comparison of Rectal Infiltration of Exparel vs. 0.25% Bupivacaine With Epinephrine vs. Placebo for Analgesic Benefit Following Hemorrhoidectomy

• Status: Terminated
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 11 (actual)
• Sponsor: St. Luke's-Roosevelt Hospital Center · Academic / Other
• Sex: All
• Age: 21 Years – 65 Years
• Healthy volunteers: Accepted

Summary

The purpose of this study is to compare the quality and duration of pain relief after a hemorrhoidectomy, provided by locally administered liposomal bupivacaine versus bupivacaine hcl or control with saline. It is hypothesized that liposomal bupivacaine will provide more effective postoperative pain relief than both bupivacaine hcl and the control.

Conditions

• Hemorrhoid

Interventions

Type	Name	Description
DRUG	Exparel	266 mg/20mL Exparel (to be diluted with 10 mL sterile saline to make 30 mL)
DRUG	Bupivacaine HCl with Epinephrine	75mg/30mL 0.25% Bupivacaine HCl with epinephrine
DRUG	Normal Saline	30mL Normal Saline

Timeline

• Start date: 2014-04-01
• Primary completion: 2016-01-01
• Completion: 2016-01-01
• First posted: 2014-04-04
• Last updated: 2018-12-04
• Results posted: 2018-12-04

Locations

1 site across 1 country: United States