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

Phase 4

Terminated

• Conditions: Postoperative Pain
• Interventions: Drug: EXPAREL

• Registration Number: NCT01919606
• Lead Sponsor: Pacira Pharmaceuticals, Inc

Brief 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.

Study Timeline

• Study Start: 2012-08
• Primary Completion: 2012-10
• Study Completion: 2012-10
• Study First Submitted: 2013-02-26
• Study First Submitted QC: 2013-08-07
• Study First Posted: 2013-08-09
• Results First Submitted: 2014-04-15
• Results First Submitted QC: 2014-04-15
• Results First Posted: 2014-05-14
• Status Verified: 2021-02
• Last Update Submitted: 2021-02-11
• Last Update Posted: 2021-03-02

Recruitment & Eligibility

• Status: TERMINATED
• Sex: Female
• Target Recruitment: 1

Inclusion Criteria

• Females, 18-75 years of age inclusive.
• American Society of Anesthesiologist (ASA) physical status 1-3.
• Undergoing open total abdominal hysterectomy (i.e., laparoscopic procedures are not sufficient) without any concurrent surgical procedure(s).
• Physically and mentally able to participate in the study and complete all study assessments.
• Able to give fully informed consent to participate in this study after demonstrating a good understanding of the risks and benefits of the TAP.

Exclusion Criteria

• Demonstrated hypersensitivity or idiosyncratic reactions to amide-type local anesthetics.
• Any subject whose anatomy, or surgical procedure, in the opinion of the Investigator, might preclude the potential successful performance of a TAP.
• Any subject who in the opinion of the Investigator might be harmed or be a poor candidate for participation in the study.
• Any subject, who in the opinion of the Investigator, is on chronic pain medicine.
• Subjects who have received any investigational drug within 30 days prior to study drug administration, or planned administration of another investigational product or procedure during their participation in this study.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
EXPAREL Group 2	EXPAREL	EXPAREL 266 mg diluted with saline to a volume of 60 mL
EXPAREL Group 1	EXPAREL	EXPAREL 266 mg diluted with saline to a volume of 40 mL

Primary Outcome Measures

Name	Time	Method
Duration of Analgesia	End of surgery to time of subject's first postsurgical opioid administration (through 72 hours)

Secondary Outcome Measures

Name	Time	Method
Incidence of Adverse Events	10 days post surgery plus or minus 3 days