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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01582477
Other study ID # MA402S23B701
Secondary ID
Status Completed
Phase Phase 4
First received
Last updated
Start date March 2012
Est. completion date July 2012

Study information

Verified date June 2021
Source Pacira Pharmaceuticals, Inc
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The purpose of the study is to assess the safety and efficacy of EXPAREL when administered via infiltration into the transversus abdominis plane (TAP) to prolonged postsurgical analgesia in men undergoing robot-assisted laparoscopic prostatectomy.


Description:

Assess the safety and efficacy of EXPAREL when administered via infiltration into the transversus abdominis plane (TAP) to provide prolonged postsurgical analgesia in men undergoing robot-assisted laparoscopic prostatectomy. The primary endpoint is the duration of abdominal analgesia from the infiltration into the TAP as measured by the time to the subject's first postsurgical opioid administration.


Recruitment information / eligibility

Status Completed
Enrollment 24
Est. completion date July 2012
Est. primary completion date May 2012
Accepts healthy volunteers No
Gender Male
Age group 18 Years to 75 Years
Eligibility Inclusion Criteria: - male subjects, aged 18-75. - American Society of Anesthesiology (ASA) physical status 1-3. - Undergoing robot-assisted laparoscopic prostatectomy performed by a single surgeon (Ingolf Tuerk, MD). - Subjects must be physically and mentally able to participate in the study and complete all study assessments. - Subjects must be able to give fully informed consent to participate in this study after demonstrating a good understanding of the risks and benefits of the TAP infiltration. Exclusion Criteria: - Demonstrated hypersensitivity or idiosyncratic reactions to amide-type local anesthetics. - Inability to tolerate oxycodone with acetaminophen (e.g. Percocet). - 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. - 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


Intervention

Drug:
EXPAREL 20 mL
EXPAREL 266 mg (undiluted)
EXPAREL 40 mL
EXPAREL 266 mg diluted with preservative-free 0.9% normal saline to 40 mL.

Locations

Country Name City State
United States Steward St. Elizabeth's 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 The Duration of Abdominal Analgesia From Infiltration Into the TAP First postsurgical administration of an opioid
Secondary Subject Reported Postsurgical Pain 11-point numeric rating scale (NRS) (0-10, where 0=no pain, 10=worst possible pain) 1, 2, 6, 12, 24, 48, 72, 96 hours and 10 days after TAP
Secondary Physician/Healthcare Professional Assessed Postsurgical Pain 11-point NRS (0-10, 0=no pain, 10=worst possible pain) 1, 2, 6, 12, 24 hours after TAP
Secondary Total Postsurgical Oxycodone/Acetaminophen Consumption From Hospital Discharge Through Hour 96. Number of pills 48, 72, 96 hours
Secondary Incidence of Prespecified Opioid-related Adverse Events Number of subjects Until hospital discharge order was written, anticipated at 24 hours.
Secondary Overall Rating of Subject Satisfaction With Postsurgical Pain Control Mean of subject satisfaction offered on a 5-point Likert scale (1 = extremely dissatisfied, 2 = dissatisfied, 3 = neither satisfied nor dissatisfied, 4 = satisfied, 5 = extremely satisfied) 24 hours, 72 hours, and day 10
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