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

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Postoperative Pain

Intervention / Treatment
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* Drug: EXPAREL


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: EXPAREL Group 1<br>EXPAREL 266 mg diluted with saline to a volume of 40 mL | Drug: EXPAREL<br>* Single-dose EXPAREL diluted with 20 mL or 40 mL saline to a volume of 40 mL or 60 mL, respectively.<br>* Other names: Bupivacaine liposome injectable suspension;|
| Experimental: EXPAREL Group 2<br>EXPAREL 266 mg diluted with saline to a volume of 60 mL | Drug: EXPAREL<br>* Single-dose EXPAREL diluted with 20 mL or 40 mL saline to a volume of 40 mL or 60 mL, respectively.<br>* Other names: Bupivacaine liposome injectable suspension;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Duration of Analgesia |  | End of surgery to time of subject's first postsurgical opioid administration (through 72 hours) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of Adverse Events |  | 10 days post surgery plus or minus 3 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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hysterectomy, analgesia