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

NCT01919190 | Terminated Phase 4 Results

• 1 other identifier: MSE402
• Study Type: interventional
• Target: 67
• Locations: 1 country
• Sites: 13

Brief 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.

Conditions

Pain

Outcome Measures

Primary Outcomes (2)

• 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

• 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 Outcomes (4)

• Extent and Degree of Anesthetic Blockade

  Prior to TAP, immediately postoperatively, and daily through discharge or Day 4

• Severity of Postsurgical Pain

  Immediately in PACU postsurgery and prior to pain medication until discharge (or Day 4)

• Quality of Recovery

  Daily through Post Op Day 4

• Frequency of Patient Calls Post-discharge

  Post-discharge through 4 days postsurgery

Study Arms (2)

EXPAREL

ACTIVE COMPARATOR

EXPAREL (266mg/20 ml) with 40 mL of 0.9% normal saline for a total volume of 60 mL, 30 mL to be administered to the right TAP and 30 mL to be administered to the left TAP

Drug: EXPAREL

Placebo

SHAM COMPARATOR

The placebo control will be established using a grade-2 sham, no infiltration will occur

Drug: Placebo

Interventions

EXPAREL DRUG

TAP with EXPAREL

Also known as: bupivacaine liposome injectable suspension.

EXPAREL

Placebo DRUG

Placebo

Also known as: Placebo using grade-2 sham, no infiltration

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Pacira Pharmaceuticals, Inc: lead

Study Sites (13)

Florida Hospital

Winter Park, Florida, 32792, United States

Location

Memorial Health University Medical Center

Savannah, Georgia, 31404, United States

Location

Northwestern University

Chicago, Illinois, 60208, United States

Location

University of Louisville

Louisville, Kentucky, 40202, United States

Location

Berkshire Medical Center

Pittsfield, Massachusetts, 01210, United States

Location

University of Minnesota

Minneapolis, Minnesota, 55404, United States

Location

Montefiore Medical Center

The Bronx, New York, 10467, United States

Location

Duke University

Durham, North Carolina, 27705, United States

Location

Fairview Hospital

Cleveland, Ohio, 44111, United States

Location

The Ohio State University

Columbus, Ohio, 43210, United States

Location

Thomas Jefferson University

Philadelphia, Pennsylvania, 19107, United States

Location

UPMC St. Margaret's Hospital

Pittsburgh, Pennsylvania, 15215, United States

Location

St. John Hospital

Houston, Texas, 77081, United States

Location

MeSH Terms

Conditions

Pain

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Paci
• Organization: Pacira Pharmaceuticals, Inc.

MedInfo@pacira.com

1-855-793-9727

Study Officials

• Kay Warnott, RN

  Pacira Pharmaceuticals, Inc

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 6, 2013
• First Posted: August 8, 2013
• Study Start: August 1, 2013
• Primary Completion: December 1, 2013
• Study Completion: February 1, 2014
• Last Updated: July 2, 2021
• Results First Posted: July 2, 2021

Record last verified: 2021-06

Locations

US (13)