TAP-patients With Robotic Assisted Lap Prostatectomy

Analgesia Clinical Trial

— 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01582477
• Other study ID #: MA402S23B701
• Status: Completed
• Phase: Phase 4
• 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
• 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.

Related Conditions & MeSH terms

• Analgesia
• Pain, Postoperative
• Postsurgical Pain
• Prostatectomy

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