Steward St. Elizabeth's
Brighton, Massachusetts, 02135, United States
NCT Number: NCT01582477
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.
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Notify Me18 year–75 year
Male
Interventional
Phase 4
Brighton, Massachusetts, 02135, United States
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
EXPAREL 266 mg (undiluted)
Other names: bupivacaine liposome injectable suspension
EXPAREL 266 mg diluted with preservative-free 0.9% normal saline to 40 mL.
Other names: bupivacaine liposome injectable suspension
Time frame: First postsurgical administration of an opioid
Time frame: 1, 2, 6, 12, 24, 48, 72, 96 hours and 10 days after TAP
11-point numeric rating scale (NRS) (0-10, where 0=no pain, 10=worst possible pain)
Time frame: 1, 2, 6, 12, 24 hours after TAP
11-point NRS (0-10, 0=no pain, 10=worst possible pain)
Time frame: 48, 72, 96 hours
Number of pills
Time frame: Until hospital discharge order was written, anticipated at 24 hours.
Number of subjects
Time frame: 24 hours, 72 hours, and day 10
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)
Pacira Pharmaceuticals, Inc
Industry
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
Acronym: TAP
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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