Back to resultsTAP-patients With Robotic Assisted Lap Prostatectomy (TAP)
Primary Purpose
Postsurgical Pain, Analgesia, Prostatectomy
Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
EXPAREL 20 mL
EXPAREL 40 mL
Sponsored by
About this trial
This is an interventional treatment trial for Postsurgical Pain focused on measuring TAP, robot-assisted prostatectomy
Eligibility Criteria
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.
Sites / Locations
- Steward St. Elizabeth's
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
EXPAREL 20 mL (undiluted)
EXPAREL 40 mL (diluted)
Arm Description
20 mL (266 mg) undiluted EXPAREL with 133 mg infiltrated on each the right and left side of the abdomen.
20 mL (266 mg) EXPAREL diluted with an equal volume of preservative-free 0.9% normal saline to a total of 40 mL and infiltrated equally to the right and left side of the abdomen.
Outcomes
Primary Outcome Measures
The Duration of Abdominal Analgesia From Infiltration Into the TAP
Secondary Outcome Measures
Subject Reported Postsurgical Pain
11-point numeric rating scale (NRS) (0-10, where 0=no pain, 10=worst possible pain)
Physician/Healthcare Professional Assessed Postsurgical Pain
11-point NRS (0-10, 0=no pain, 10=worst possible pain)
Total Postsurgical Oxycodone/Acetaminophen Consumption From Hospital Discharge Through Hour 96.
Number of pills
Incidence of Prespecified Opioid-related Adverse Events
Number of subjects
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)
Full Information
NCT ID
NCT01582477
First Posted
April 19, 2012
Last Updated
June 11, 2021
Sponsor
Pacira Pharmaceuticals, Inc
1. Study Identification
Unique Protocol Identification Number
NCT01582477
Brief Title
TAP-patients With Robotic Assisted Lap Prostatectomy
Acronym
TAP
Official 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
Study Type
Interventional
2. Study Status
Record Verification Date
June 2021
Overall Recruitment Status
Completed
Study Start Date
March 2012 (undefined)
Primary Completion Date
May 2012 (Actual)
Study Completion Date
July 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Pacira Pharmaceuticals, Inc
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief 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.
Detailed 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postsurgical Pain, Analgesia, Prostatectomy
Keywords
TAP, robot-assisted prostatectomy
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
24 (Actual)
8. Arms, Groups, and Interventions
Arm Title
EXPAREL 20 mL (undiluted)
Arm Type
Experimental
Arm Description
20 mL (266 mg) undiluted EXPAREL with 133 mg infiltrated on each the right and left side of the abdomen.
Arm Title
EXPAREL 40 mL (diluted)
Arm Type
Active Comparator
Arm Description
20 mL (266 mg) EXPAREL diluted with an equal volume of preservative-free 0.9% normal saline to a total of 40 mL and infiltrated equally to the right and left side of the abdomen.
Intervention Type
Drug
Intervention Name(s)
EXPAREL 20 mL
Other Intervention Name(s)
bupivacaine liposome injectable suspension
Intervention Description
EXPAREL 266 mg (undiluted)
Intervention Type
Drug
Intervention Name(s)
EXPAREL 40 mL
Other Intervention Name(s)
bupivacaine liposome injectable suspension
Intervention Description
EXPAREL 266 mg diluted with preservative-free 0.9% normal saline to 40 mL.
Primary Outcome Measure Information:
Title
The Duration of Abdominal Analgesia From Infiltration Into the TAP
Time Frame
First postsurgical administration of an opioid
Secondary Outcome Measure Information:
Title
Subject Reported Postsurgical Pain
Description
11-point numeric rating scale (NRS) (0-10, where 0=no pain, 10=worst possible pain)
Time Frame
1, 2, 6, 12, 24, 48, 72, 96 hours and 10 days after TAP
Title
Physician/Healthcare Professional Assessed Postsurgical Pain
Description
11-point NRS (0-10, 0=no pain, 10=worst possible pain)
Time Frame
1, 2, 6, 12, 24 hours after TAP
Title
Total Postsurgical Oxycodone/Acetaminophen Consumption From Hospital Discharge Through Hour 96.
Description
Number of pills
Time Frame
48, 72, 96 hours
Title
Incidence of Prespecified Opioid-related Adverse Events
Description
Number of subjects
Time Frame
Until hospital discharge order was written, anticipated at 24 hours.
Title
Overall Rating of Subject Satisfaction With Postsurgical Pain Control
Description
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)
Time Frame
24 hours, 72 hours, and day 10
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Andrew Sternlicht, MD
Organizational Affiliation
Steward St. Elizabeth's
Official's Role
Principal Investigator
Facility Information:
Facility Name
Steward St. Elizabeth's
City
Brighton
State/Province
Massachusetts
ZIP/Postal Code
02135
Country
United States
12. IPD Sharing Statement
Learn more about this trial
TAP-patients With Robotic Assisted Lap Prostatectomy
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