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.
Brief Title
EXPAREL Administered by Infiltration Into the TAP for Prolonged Postsurgical Analgesia in Lower Abdominal Surgeries
Detailed 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.
Categories
Completion Date
Completion Date Type
Actual
Conditions
Pain
Eligibility Criteria
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.
* 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.
Inclusion Criteria
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.
* 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.
Gender
All
Gender Based
false
Healthy Volunteers
No
Last Update Post Date
Last Update Post Date Type
Actual
Last Update Submit Date
Minimum Age
18 Years
NCT Id
NCT01919190
Org Class
Industry
Org Full Name
Pacira Pharmaceuticals, Inc
Org Study Id
MSE402
Overall Status
Terminated
Phases
Phase 4
Primary Completion Date
Primary Completion Date Type
Actual
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
Primary Outcomes
Outcome Description
Total Opioid Consumption Post Surgery (cumulative total) Until Discharge Readiness or Post Surgery Day 4
Outcome Measure
Total Opioid Consumption Post Surgery (Cumulative Total) Until Discharge Readiness or Post Surgery Day 4
Outcome Time Frame
From surgery through 4 days postsurgery
Outcome Description
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)
Outcome Measure
Overall Benefit of Analgesic Score (OBAS) at Day 3
Outcome Time Frame
Postsurgical day 1 through day 3
Secondary Outcomes
Outcome Description
Extent and degree of anesthetic blockage measured using a 5-point sensation scale.
Outcome Time Frame
Prior to TAP, immediately postoperatively, and daily through discharge or Day 4
Outcome Measure
Extent and Degree of Anesthetic Blockade
Outcome Description
Severity of postsurgical pain measured using an 11-point numerical rating scale (NRS 0-10).
Outcome Time Frame
Immediately in PACU postsurgery and prior to pain medication until discharge (or Day 4)
Outcome Measure
Severity of Postsurgical Pain
Outcome Description
Measured using the Quality of Recovery 15 questionnaire (QoR-15)
Outcome Time Frame
Daily through Post Op Day 4
Outcome Measure
Quality of Recovery
Outcome Description
Frequency of patient calls post-discharge related to pain and unscheduled hospital/surgeon visits
Outcome Time Frame
Post-discharge through 4 days postsurgery
Outcome Measure
Frequency of Patient Calls Post-discharge
Start Date
Status Verified Date
First Post Date
First Post Date Type
Estimated
First Submit Date
First Submit QC Date
Std Ages
Adult
Older Adult
Maximum Age Number (converted to Years and rounded down)
999
Minimum Age Number (converted to Years and rounded down)
18
Investigators
Investigator Type
Principal Investigator
Investigator Name
Boleslav Kosharskyy
Investigator Email
bkoshars@montefiore.org
Investigator Phone