Postoperative PainPhase 4NCT01919606
EXPAREL Administered Into the TAP for Analgesia in Subjects Undergoing Open Total Abdominal Hysterectomy
A Phase 4 study testing EXPAREL in people with Postoperative Pain, run by Pacira Pharmaceuticals, Inc.
Trial summary
The primary objective of this study is to determine the optimal of two different volumes of EXPAREL 266 mg when administered via infiltration into the transversus abdominis plane (TAP) for prolonged postoperative analgesia in subjects undergoing open total abdominal hysterectomy. Read more about this study
- Who is it for?
- Ages 18 to 75 years, women only
- Conditions the study is for
- Postoperative Pain
- What is being tested?
- EXPAREL
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1 participants
- Where
- No sites listed yet
- Study dates
- Aug 2012to Oct 2012
- 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 to 75 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Females, 18-75 years of age inclusive.
- American Society of Anesthesiologist (ASA) physical status 1-3.
- Undergoing open total abdominal hysterectomy (i.e., laparoscopic procedures are not sufficient) without any concurrent surgical procedure(s).
- Physically and mentally able to participate in the study and complete all study assessments.
- Able to give fully informed consent to participate in this study after demonstrating a good understanding of the risks and benefits of the TAP.
Who cannot join
- Demonstrated hypersensitivity or idiosyncratic reactions to amide-type local anesthetics.
- Any subject whose anatomy, or surgical procedure, in the opinion of the Investigator, might preclude the potential successful performance of a TAP.
- Any subject who in the opinion of the Investigator might be harmed or be a poor candidate for participation in the study.
- Any subject, who in the opinion of the Investigator, is on chronic pain medicine.
- Subjects who have received any investigational drug within 30 days prior to study drug administration, or planned administration of another investigational product or procedure during their participation in this study.
About this study
Official title: Evaluation of the Safety and Efficacy of EXPAREL(R) (Bupivacaine Liposome Injectable Suspension) When Administered Into the Transversus Abdominis Plane (TAP) for Prolonged Postoperative Analgesia in Subjects Undergoing Open Total Abdominal Hysterectomy
The primary objective of this study is to determine the optimal of two different volumes of EXPAREL 266 mg when administered via infiltration into the transversus abdominis plane (TAP) for prolonged postoperative analgesia in subjects undergoing open total abdominal hysterectomy.
Read the detailed description
This is a prospective, open-label, non-randomized study with two treatment groups differing only in the volume of EXPAREL infiltrated into the TAP. All subjects will undergo an open total abdominal hysterectomy. The dose of EXPAREL for the TAPs will be the same for all 20 subjects, 133 mg on the right side of the abdomen and 133 mg on the left side of the abdomen.
- Conditions
- Postoperative Pain
- Being tested
- EXPAREL
- Keywords
- hysterectomy, analgesia
- Medical subject headings
- Pain, Postoperative, Agnosia
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
Single-dose EXPAREL diluted with 20 mL or 40 mL saline to a volume of 40 mL or 60 mL, respectively.
| Study group | Role | What they receive |
|---|---|---|
| EXPAREL Group 1 | Experimental | EXPAREL 266 mg diluted with saline to a volume of 40 mL Receives: Drug: EXPAREL |
| EXPAREL Group 2 | Experimental | EXPAREL 266 mg diluted with saline to a volume of 60 mL Receives: Drug: EXPAREL |
What is being measured
The primary outcome is the main question the study is designed to answer.
Duration of Analgesia
Measured: End of surgery to time of subject's first postsurgical opioid administration (through 72 hours)
Secondary outcomes (1)
Incidence of Adverse Events
Measured: 10 days post surgery plus or minus 3 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Aug 2013 (estimated)
- Study startAug 2012
- Primary completionOct 2012
- Study completionOct 2012
Why it stopped: Lack of enrollment
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 Postoperative 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
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 1 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pacira Pharmaceuticals, Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Robert Dorian, MD, Principal investigator, St. Barnabas Medical Center, Livingston, NJ 07039Thad Denehy, MD, Principal investigator, St. Barnabas Medical Center, Livingston, NJ 07039
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01919606
- Sponsor's protocol ID
- MA402S23B703
- Status last verified
- Feb 2021
- First submitted
- 26 Feb 2013
- Last updated
- 2 Mar 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 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Safety and Efficacy of EXPAREL(R) (Bupivacaine Liposome Injectable Suspension) When Administered Into the Transversus Abdominis Plane (TAP) for Prolonged Postoperative Analgesia in Subjects Undergoing Open Total Abdominal Hysterectomy
- ClinicalTrials.gov ID
- NCT01919606
- Acronym / sponsor ID
- MA402S23B703
- Conditions
- Postoperative Pain
- Keywords
- hysterectomy, analgesia
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Lack of enrollment
- Enrolment
- 1 participants (actual)
- Lead sponsor
- Pacira Pharmaceuticals, IncIndustry (pharma, biotech, devices)
- Study start
- Aug 2012
- Primary completion
- Oct 2012 (actual)
- Study completion
- Oct 2012 (actual)
- First posted
- 9 Aug 2013 (estimated)
- Results
- Posted 14 May 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The primary objective of this study is to determine the optimal of two different volumes of EXPAREL 266 mg when administered via infiltration into the transversus abdominis plane (TAP) for prolonged postoperative analgesia in subjects undergoing open total abdominal hysterectomy.
Detailed description
This is a prospective, open-label, non-randomized study with two treatment groups differing only in the volume of EXPAREL infiltrated into the TAP. All subjects will undergo an open total abdominal hysterectomy. The dose of EXPAREL for the TAPs will be the same for all 20 subjects, 133 mg on the right side of the abdomen and 133 mg on the left side of the abdomen.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| EXPAREL Group 1 | Experimental | Drug: EXPARELEXPAREL 266 mg diluted with saline to a volume of 40 mL |
| EXPAREL Group 2 | Experimental | Drug: EXPARELEXPAREL 266 mg diluted with saline to a volume of 60 mL |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Females, 18-75 years of age inclusive.
- American Society of Anesthesiologist (ASA) physical status 1-3.
- Undergoing open total abdominal hysterectomy (i.e., laparoscopic procedures are not sufficient) without any concurrent surgical procedure(s).
- Physically and mentally able to participate in the study and complete all study assessments.
- Able to give fully informed consent to participate in this study after demonstrating a good understanding of the risks and benefits of the TAP.
Key exclusion criteria (5 listed)
- Demonstrated hypersensitivity or idiosyncratic reactions to amide-type local anesthetics.
- Any subject whose anatomy, or surgical procedure, in the opinion of the Investigator, might preclude the potential successful performance of a TAP.
- Any subject who in the opinion of the Investigator might be harmed or be a poor candidate for participation in the study.
- Any subject, who in the opinion of the Investigator, is on chronic pain medicine.
- Subjects who have received any investigational drug within 30 days prior to study drug administration, or planned administration of another investigational product or procedure during their participation in this study.
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 suspensionSingle-dose EXPAREL diluted with 20 mL or 40 mL saline to a volume of 40 mL or 60 mL, respectively. | Drug | EXPAREL Group 1, EXPAREL Group 2 |
Primary outcome
Duration of Analgesia
Time frame: End of surgery to time of subject's first postsurgical opioid administration (through 72 hours)
1 secondary outcome
Incidence of Adverse Events
Time frame: 10 days post surgery plus or minus 3 days
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Mar 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.
Robert Dorian, MD principal investigator
St. Barnabas Medical Center, Livingston, NJ 07039
Thad Denehy, MD principal investigator
St. Barnabas Medical Center, Livingston, NJ 07039
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing EXPAREL in people with Postoperative Pain, run by Pacira Pharmaceuticals, Inc.
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 5 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 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. 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 14 May 2014). 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?
Duration of Analgesia (time frame: End of surgery to time of subject's first postsurgical opioid administration (through 72 hours)). 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 Mar 2021.