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

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Pacira

Status and phase

Terminated
Phase 4

Conditions

Pain

Treatments

Drug: Placebo
Drug: EXPAREL

Study type

Interventional

Funder types

Industry

Identifiers

Details and patient eligibility

About

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.

Full 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.

Enrollment

67 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

67 participants in 2 patient groups

EXPAREL
Active Comparator group
Description:
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
Treatment:
Drug: EXPAREL
Placebo
Sham Comparator group
Description:
The placebo control will be established using a grade-2 sham, no infiltration will occur
Treatment:
Drug: Placebo

Trial contacts and locations

13

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Data sourced from clinicaltrials.gov

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