Assessing the Impact of EXPAREL(R) on Opioid Use and Patient Reported Outcomes When Administered by Infiltration Into the Transversus Abdominis Plane (TAP) Under Ultrasound Guidance for Prolonged Postsurgical Analgesia in Lower Abdominal Surgeries (TRANSCEND)

NCT01919190 Phase 4 TERMINATED Results posted

The purpose of this prospective, blinded assessor, randomized trial is to assess opioid use and patient-reported outcomes of EXPAREL as a foundation in postsurgical pain therapy in Transversus Abdominis Plane (TAP) infiltration in lower abdominal surgical procedures.

Details

Lead sponsor	Pacira Pharmaceuticals, Inc
Phase	Phase 4
Status	TERMINATED
Enrolment	67
Start date	2013-08
Completion	2014-02

Conditions

• Pain

Interventions

• EXPAREL
• Placebo

Primary outcomes

• Total Opioid Consumption Post Surgery (Cumulative Total) Until Discharge Readiness or Post Surgery Day 4 — From surgery through 4 days postsurgery
  Total Opioid Consumption Post Surgery (cumulative total) Until Discharge Readiness or Post Surgery Day 4
• Overall Benefit of Analgesic Score (OBAS) at Day 3 — Postsurgical day 1 through day 3
  Severity of postsurgical pain, satisfaction with pain management, and impact of opioid-related symptom distress measured using the Overall Benefit of Analgesic Score (OBAS) - primary endpoint is mean difference in OBAS at Day 3. (0=minimal pain and 4=maximum imaginable pain)

Countries

United States