EXPAREL Administered by Infiltration Into the TAP for Prolonged Postsurgical Analgesia in Lower Abdominal Surgeries

Pain Clinical Trial

— TRANSCEND  

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01919190
• Other study ID #: MSE402
• Status: Terminated
• Phase: Phase 4
• Start date: August 2013
• Est. completion date: February 2014

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 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.

Description:

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; primary endpoint signal seen during pre-specified interim analysis.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 67
• Est. completion date: February 2014
• Est. primary completion date: December 2013
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Males and females >18 years of age

• American Society of Anesthesiologists (ASA) physical status 1-3

• Undergoing either lower abdominal surgery defined as Laparoscopic Hysterectomy (female), Laparoscopic Myomectomy (female), Laparoscopic Colectomy (male/female)

• Physically and mentally able to give full informed consent to participate in this study and complete all study assessments within the timeframes required (including electronic diaries should patient be discharged prior to day 4)

• Capable of returning the diary after POD 4 by mail (preferably) or upon follow up visit.

Exclusion Criteria:

• History of hypersensitivity or idiosyncratic reactions to amide-type local anesthetics.

• Any patient whose anatomy, or surgical procedure, in the opinion of the Investigator, might preclude the potential successful local administration of EXPAREL.

• Patients who have received any investigational drug within 30 days prior to EXPAREL administration, or planned administration of another investigational product or procedure during their participation in this study.

• Any chronic condition requiring use of opioids for treatment of a medical condition for 2 weeks or more prior to surgery.

• Confirmed pregnancy at time of enrollment or breast feeding (females of child-bearing potential).

• Patients that would constitute a contraindication to participation in the study, or cause inability to comply with the study requirements.

• Any patient with diagnosed or potential metastatic disease.

• Any condition that in the investigator's opinion might be harmed or be a poor candidate for participation in the study (such as patients requiring long acting opioids as part of the induction medications).

• Initiation of treatment with any of the following medications within 1 month of study drug administration or if the medication(s) are being given to control pain: selective serotonin reuptake inhibitors (SSRIs), selective norepinephrine reuptake inhibitors (SNRIs), gabapentin, pregabalin (Lyrica®), or duloxetine (Cymbalta®)

• History of suspected or known addiction to, or abuse of, illicit drug(s), prescription medicine(s), or alcohol within the past 2 years.

Related Conditions & MeSH terms

• Pain

Intervention

Drug:
• EXPAREL
TAP with EXPAREL
• Placebo
Placebo

Locations

Country	Name	City	State
United States	Montefiore Medical Center	Bronx	New York
United States	Northwestern University	Chicago	Illinois
United States	Fairview Hospital	Cleveland	Ohio
United States	The Ohio State University	Columbus	Ohio
United States	Duke University	Durham	North Carolina
United States	St. John Hospital	Houston	Texas
United States	University of Louisville	Louisville	Kentucky
United States	University of Minnesota	Minneapolis	Minnesota
United States	Thomas Jefferson University	Philadelphia	Pennsylvania
United States	UPMC St. Margaret's Hospital	Pittsburgh	Pennsylvania
United States	Berkshire Medical Center	Pittsfield	Massachusetts
United States	Memorial Health University Medical Center	Savannah	Georgia
United States	Florida Hospital	Winter Park	Florida

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	Total Opioid Consumption Post Surgery (Cumulative Total) Until Discharge Readiness or Post Surgery Day 4	Total Opioid Consumption Post Surgery (cumulative total) Until Discharge Readiness or Post Surgery Day 4	From surgery through 4 days postsurgery
Primary	Overall Benefit of Analgesic Score (OBAS) at 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)	Postsurgical day 1 through day 3
Secondary	Extent and Degree of Anesthetic Blockade	Extent and degree of anesthetic blockage measured using a 5-point sensation scale.	Prior to TAP, immediately postoperatively, and daily through discharge or Day 4
Secondary	Severity of Postsurgical Pain	Severity of postsurgical pain measured using an 11-point numerical rating scale (NRS 0-10).	Immediately in PACU postsurgery and prior to pain medication until discharge (or Day 4)
Secondary	Quality of Recovery	Measured using the Quality of Recovery 15 questionnaire (QoR-15)	Daily through Post Op Day 4
Secondary	Frequency of Patient Calls Post-discharge	Frequency of patient calls post-discharge related to pain and unscheduled hospital/surgeon visits	Post-discharge through 4 days postsurgery