Status:
TERMINATED
EXPAREL Administered Into the TAP for Analgesia in Subjects Undergoing Open Total Abdominal Hysterectomy
Lead Sponsor:
Pacira Pharmaceuticals, Inc
Conditions:
Postoperative Pain
Eligibility:
FEMALE
18-75 years
Phase:
PHASE4
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 p...
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 hy...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
August 1 2012
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2012
Estimated Enrollment :
1 Patients enrolled
Trial Details
Trial ID
NCT01919606
Start Date
August 1 2012
End Date
October 1 2012
Last Update
March 2 2021
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