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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01582490
Other study ID # MA402S23B901
Secondary ID
Status Completed
Phase Phase 4
First received April 19, 2012
Last updated May 31, 2014
Start date April 2012
Est. completion date November 2012

Study information

Verified date May 2014
Source Pacira Pharmaceuticals, Inc
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Interventional

Clinical Trial Summary

This is a Phase 4, prospective, open-label, non-randomized, sequential study with two treatment groups differing only in the technique used for EXPAREL administration (instillation or infiltration).


Description:

Each subject underwent bilateral augmentation mammoplasty and received the same dose of EXPAREL. This primary objective of this study was to assess the efficacy of EXPAREL when administered via infiltration versus instillation as part of bilateral augmentation mammoplasty. The secondary objectives were to further assess other efficacy measures and the safety profile of EXPAREL.


Recruitment information / eligibility

Status Completed
Enrollment 19
Est. completion date November 2012
Est. primary completion date November 2012
Accepts healthy volunteers No
Gender Female
Age group 18 Years to 75 Years
Eligibility Inclusion Criteria:

- Female, 18-75 years of age inclusive.

- American Society of Anesthesiologists (ASA) physical status 1-3.

- Undergoing bilateral augmentation mammoplasty 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 study components.

Exclusion Criteria:

- History of hypersensitivity or idiosyncratic reactions to amide-type local anesthetics.

- Any subject whose anatomy or surgical procedure might, in the opinion of the Investigator, preclude the potential successful local administration of EXPAREL.

- Subjects currently pregnant or who may become pregnant during the course of the study.

- Any subject who in the opinion of the Investigator might be harmed or be a poor candidate for participation in the study.

- 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

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Drug:
Instillation - EXPAREL
Intravenous (IV) morphine sulfate, hydromorphone, or oral oxycodone with acetaminophen (5/325 mg) will be permitted following surgery, as needed.
Infiltration - EXPAREL
IV morphine sulfate, hydromorphone, or oral oxycodone with acetaminophen (5/325 mg) will be permitted following surgery, as needed.

Locations

Country Name City State
United States Steward St. Elizabeth's Medical Center Brighton Massachusetts

Sponsors (1)

Lead Sponsor Collaborator
Pacira Pharmaceuticals, Inc

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Duration of Analgesia The primary outcome measure is the duration of analgesia, measured by the time (hours) from the end surgery to the subject's first postsurgical opioid administration. 10 days No
Secondary Total Postsurgical Opioid Consumption in the Surgical Center Total amount of opioids (morphine-equivalent mg) administered postsurgically in each group. 10 days No
Secondary Pain Intensity Assessment Upon Waking in the PACU Subject-reported pain assessment upon waking in the PACU on a scale of 0 to 10 where 0 = no pain and 10 = worst possible pain. Upon waking in the PACO post surgery Yes
Secondary Pain Intensity Assessment at the Time of Hospital Discharge Subject-reported pain assessment at the time of hospital discharge (assessed an average of 3.11 hours after surgery for the Instillation group and 3.20 hours after surgery for the Infiltration group) on a scale from 0 to 10 where 0 = no pain and 10 = worst possible pain. At the time of hospital discharge Yes
Secondary Time to Hospital Discharge Being Written The time (hours) to the hospital discharge being written for subjects in each group, At the time of hospital discharge Yes
Secondary Incidence of Opioid-Related Adverse Events The incidence of adverse events that were assessed as opioid-related Through 10 Days Post Surgery Yes
Secondary Overall Rating of Subject Satisfaction With Postsurgical Pain Control at Hospital Discharge Subject-reported satisfaction with postsurgical pain control in the categories of "extremely dissatisfied," "dissatisfied," "neither satisfied nor dissatisfied," "satisfied," and "extremely satisfied." At the time of hospital discharge Yes
Secondary Overall Rating of Subject Satisfaction With Postsurgical Pain Control at Day 10 Subject-reported satisfaction with postsurgical pain control in the categories of "extremely dissatisfied," "dissatisfied," "neither satisfied nor dissatisfied," "satisfied," and "extremely satisfied." Day 10 after surgery Yes
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