Analgesia Clinical Trial
— TAPOfficial title:
Evaluation of the Safety and Efficacy of EXPAREL When Administered by Infiltration Into the Transversus Abdominis Plane (TAP) for Prolonged Postsurgical Analgesia in Subjects Undergoing Robot-assisted Laparoscopic Prostatectomy
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 |
Verified date | June 2021 |
Source | Pacira Pharmaceuticals, Inc |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
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. |
Country | Name | City | State |
---|---|---|---|
United States | Steward St. Elizabeth's | Brighton | Massachusetts |
Lead Sponsor | Collaborator |
---|---|
Pacira Pharmaceuticals, Inc |
United States,
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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