NCT01919606

EXPAREL Administered Into the TAP for Analgesia in Subjects Undergoing Open Total Abdominal Hysterectomy

Evaluation of the Safety and Efficacy of EXPAREL(R) (Bupivacaine Liposome Injectable Suspension) When Administered Into the Transversus Abdominis Plane (TAP) for Prolonged Postoperative Analgesia in Subjects Undergoing Open Total Abdominal Hysterectomy

• Status: Terminated
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 1 (actual)
• Sponsor: Pacira Pharmaceuticals, Inc · Industry
• Sex: Female
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

The primary objective of this study is to determine the optimal of two different volumes of EXPAREL 266 mg when administered via infiltration into the transversus abdominis plane (TAP) for prolonged postoperative analgesia in subjects undergoing open total abdominal hysterectomy.

Detailed description

This is a prospective, open-label, non-randomized study with two treatment groups differing only in the volume of EXPAREL infiltrated into the TAP. All subjects will undergo an open total abdominal hysterectomy. The dose of EXPAREL for the TAPs will be the same for all 20 subjects, 133 mg on the right side of the abdomen and 133 mg on the left side of the abdomen.

Conditions

• Postoperative Pain

Interventions

Type	Name	Description
DRUG	EXPAREL	Single-dose EXPAREL diluted with 20 mL or 40 mL saline to a volume of 40 mL or 60 mL, respectively.

Timeline

• Start date: 2012-08-01
• Primary completion: 2012-10-01
• Completion: 2012-10-01
• First posted: 2013-08-09
• Last updated: 2021-03-02
• Results posted: 2014-05-14