PainPhase 4TRANSCENDNCT01919190
EXPAREL Administered by Infiltration Into the TAP for Prolonged Postsurgical Analgesia in Lower Abdominal Surgeries
A Phase 4 study testing EXPAREL in people with Pain, run by Pacira Pharmaceuticals, Inc at 13 sites in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pain
- What is being tested?
- EXPAREL
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 67 participants
- Where
- 13 sitesUnited States
- Study dates
- Aug 2013to Feb 2014
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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 locations and contacts
13 sites in 1 country.
13 sites in 1 country
United States13 sites
Northwestern University
Chicago, Illinois, 60208
Fairview Hospital
Cleveland, Ohio, 44111
The Ohio State University
Columbus, Ohio, 43210
Duke University
Durham, North Carolina, 27705
St. John Hospital
Houston, Texas, 77081
University of Louisville
Louisville, Kentucky, 40202
University of Minnesota
Minneapolis, Minnesota, 55404
Thomas Jefferson University
Philadelphia, Pennsylvania, 19107
UPMC St. Margaret's Hospital
Pittsburgh, Pennsylvania, 15215
Berkshire Medical Center
Pittsfield, Massachusetts, 01210
Memorial Health University Medical Center
Savannah, Georgia, 31404
Montefiore Medical Center
The Bronx, New York, 10467
Florida Hospital
Winter Park, Florida, 32792
About this study
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
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.
Read the 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.
- Conditions
- Pain
- Being tested
- EXPAREL, Placebo
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EXPARELDrug
Also called bupivacaine liposome injectable suspension.
TAP with EXPAREL
PlaceboDrug
Also called Placebo using grade-2 sham, no infiltration
Placebo
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Drug: EXPAREL |
| Placebo | Sham comparator | The placebo control will be established using a grade-2 sham, no infiltration will occur Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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)
Measured: Postsurgical day 1 through day 3
Secondary outcomes (4)
Extent and Degree of Anesthetic Blockade
Extent and degree of anesthetic blockage measured using a 5-point sensation scale.
Measured: Prior to TAP, immediately postoperatively, and daily through discharge or Day 4
Severity of Postsurgical Pain
Severity of postsurgical pain measured using an 11-point numerical rating scale (NRS 0-10).
Measured: Immediately in PACU postsurgery and prior to pain medication until discharge (or Day 4)
Quality of Recovery
Measured using the Quality of Recovery 15 questionnaire (QoR-15)
Measured: Daily through Post Op Day 4
Frequency of Patient Calls Post-discharge
Frequency of patient calls post-discharge related to pain and unscheduled hospital/surgeon visits
Measured: Post-discharge through 4 days postsurgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Aug 2013 (estimated)
- Study startAug 2013
- Primary completionDec 2013
- Study completionFeb 2014
Why it stopped: Due to reasons unrelated to safety; primary endpoint signal seen during pre-specified interim analysis.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 67 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pacira Pharmaceuticals, Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Kay Warnott, RN, Study director, Pacira Pharmaceuticals, Inc
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01919190
- Sponsor's protocol ID
- MSE402
- Acronym
- TRANSCEND
- Status last verified
- Jun 2021
- First submitted
- 6 Aug 2013
- Last updated
- 2 Jul 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01919190
- Acronym / sponsor ID
- TRANSCEND / MSE402
- Conditions
- Pain
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Due to reasons unrelated to safety; primary endpoint signal seen during pre-specified interim analysis.
- Enrolment
- 67 participants (actual)
- Lead sponsor
- Pacira Pharmaceuticals, IncIndustry (pharma, biotech, devices)
- Study start
- Aug 2013
- Primary completion
- Dec 2013 (actual)
- Study completion
- Feb 2014 (actual)
- First posted
- 8 Aug 2013 (estimated)
- Results
- Posted 2 Jul 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| EXPAREL | Active comparator | Drug: EXPARELEXPAREL (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 |
| Placebo | Sham comparator | Drug: PlaceboThe placebo control will be established using a grade-2 sham, no infiltration will occur |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (10 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| EXPARELAlso: bupivacaine liposome injectable suspension.TAP with EXPAREL | Drug | EXPAREL |
| PlaceboAlso: Placebo using grade-2 sham, no infiltrationPlacebo | Drug | Placebo |
Primary outcome
Total Opioid Consumption Post Surgery (Cumulative Total) Until Discharge Readiness or Post Surgery Day 4
Time frame: 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
Time frame: 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)
4 secondary outcomes
Extent and Degree of Anesthetic Blockade
Time frame: Prior to TAP, immediately postoperatively, and daily through discharge or Day 4
Severity of Postsurgical Pain
Time frame: Immediately in PACU postsurgery and prior to pain medication until discharge (or Day 4)
Quality of Recovery
Time frame: Daily through Post Op Day 4
Frequency of Patient Calls Post-discharge
Time frame: Post-discharge through 4 days postsurgery
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jul 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kay Warnott, RN study director
Pacira Pharmaceuticals, Inc
13 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing EXPAREL in people with Pain, run by Pacira Pharmaceuticals, Inc at 13 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 2 Jul 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 13 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 2 Jul 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Total Opioid Consumption Post Surgery (Cumulative Total) Until Discharge Readiness or Post Surgery Day 4 (time frame: From surgery through 4 days postsurgery). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jul 2021.