Postsurgical PainPhase 4TAPNCT01582477
TAP-patients With Robotic Assisted Lap Prostatectomy
A Phase 4 study testing EXPAREL 20 mL and EXPAREL 40 mL in people with Postsurgical Pain and Analgesia, run by Pacira Pharmaceuticals, Inc at 1 site in United States.
Trial summary
The purpose of the study is to assess the safety and efficacy of EXPAREL when administered via infiltration into the transversus abdominis plane (TAP) to prolonged postsurgical analgesia in men undergoing robot-assisted laparoscopic prostatectomy. Read more about this study
- Who is it for?
- Ages 18 to 75 years, men only
- Conditions the study is for
- Postsurgical Pain, Analgesia, Prostatectomy
- What is being tested?
- EXPAREL 20 mL and EXPAREL 40 mL
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2012to Jul 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
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- male subjects, aged 18-75.
- American Society of Anesthesiology (ASA) physical status 1-3.
- Undergoing robot-assisted laparoscopic prostatectomy performed by a single surgeon (Ingolf Tuerk, MD).
- Subjects must be physically and mentally able to participate in the study and complete all study assessments.
- Subjects must be able to give fully informed consent to participate in this study after demonstrating a good understanding of the risks and benefits of the TAP infiltration.
Who cannot join
- Demonstrated hypersensitivity or idiosyncratic reactions to amide-type local anesthetics.
- Inability to tolerate oxycodone with acetaminophen (e.g. Percocet).
- 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.
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Steward St. Elizabeth's
Brighton, Massachusetts, 02135
About this study
Official title: Evaluation of the Safety and Efficacy of EXPAREL When Administered by Infiltration Into the Transversus Abdominis Plane (TAP) for Prolonged Postsurgical Analgesia in Subjects Undergoing Robot-assisted Laparoscopic Prostatectomy
The purpose of the study is to assess the safety and efficacy of EXPAREL when administered via infiltration into the transversus abdominis plane (TAP) to prolonged postsurgical analgesia in men undergoing robot-assisted laparoscopic prostatectomy.
Read the detailed description
Assess the safety and efficacy of EXPAREL when administered via infiltration into the transversus abdominis plane (TAP) to provide prolonged postsurgical analgesia in men undergoing robot-assisted laparoscopic prostatectomy. The primary endpoint is the duration of abdominal analgesia from the infiltration into the TAP as measured by the time to the subject's first postsurgical opioid administration.
- Conditions
- Postsurgical Pain, Analgesia, Prostatectomy
- Being tested
- EXPAREL 20 mL, EXPAREL 40 mL
- Keywords
- TAP, robot-assisted prostatectomy
- 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.
EXPAREL 20 mLDrug
Also called bupivacaine liposome injectable suspension
EXPAREL 266 mg (undiluted)
EXPAREL 40 mLDrug
Also called bupivacaine liposome injectable suspension
EXPAREL 266 mg diluted with preservative-free 0.9% normal saline to 40 mL.
| Study group | Role | What they receive |
|---|---|---|
| EXPAREL 20 mL (undiluted) | Experimental | 20 mL (266 mg) undiluted EXPAREL with 133 mg infiltrated on each the right and left side of the abdomen. Receives: Drug: EXPAREL 20 mL |
| EXPAREL 40 mL (diluted) | Active comparator | 20 mL (266 mg) EXPAREL diluted with an equal volume of preservative-free 0.9% normal saline to a total of 40 mL and infiltrated equally to the right and left side of the abdomen. Receives: Drug: EXPAREL 40 mL |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Duration of Abdominal Analgesia From Infiltration Into the TAP
Measured: First postsurgical administration of an opioid
Secondary outcomes (5)
Subject Reported Postsurgical Pain
11-point numeric rating scale (NRS) (0-10, where 0=no pain, 10=worst possible pain)
Measured: 1, 2, 6, 12, 24, 48, 72, 96 hours and 10 days after TAP
Physician/Healthcare Professional Assessed Postsurgical Pain
11-point NRS (0-10, 0=no pain, 10=worst possible pain)
Measured: 1, 2, 6, 12, 24 hours after TAP
Total Postsurgical Oxycodone/Acetaminophen Consumption From Hospital Discharge Through Hour 96.
Number of pills
Measured: 48, 72, 96 hours
Incidence of Prespecified Opioid-related Adverse Events
Number of subjects
Measured: Until hospital discharge order was written, anticipated at 24 hours.
Overall Rating of Subject Satisfaction With Postsurgical Pain Control
Mean of subject satisfaction offered on a 5-point Likert scale (1 = extremely dissatisfied, 2 = dissatisfied, 3 = neither satisfied nor dissatisfied, 4 = satisfied, 5 = extremely satisfied)
Measured: 24 hours, 72 hours, and day 10
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Apr 2012 (estimated)
- Study startMar 2012
- Primary completionMay 2012
- Study completionJul 2012
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 Postsurgical 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
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pacira Pharmaceuticals, Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Andrew Sternlicht, MD, Principal investigator, Steward St. Elizabeth's
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01582477
- Sponsor's protocol ID
- MA402S23B701
- Acronym
- TAP
- Status last verified
- Jun 2021
- First submitted
- 19 Apr 2012
- Last updated
- 14 Jun 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 14 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Safety and Efficacy of EXPAREL When Administered by Infiltration Into the Transversus Abdominis Plane (TAP) for Prolonged Postsurgical Analgesia in Subjects Undergoing Robot-assisted Laparoscopic Prostatectomy
- ClinicalTrials.gov ID
- NCT01582477
- Acronym / sponsor ID
- TAP / MA402S23B701
- Conditions
- Postsurgical Pain, Analgesia, Prostatectomy
- Keywords
- TAP, robot-assisted prostatectomy
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Pacira Pharmaceuticals, IncIndustry (pharma, biotech, devices)
- Study start
- Mar 2012
- Primary completion
- May 2012 (actual)
- Study completion
- Jul 2012 (actual)
- First posted
- 20 Apr 2012 (estimated)
- Results
- Posted 10 Jun 2013
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 the study is to assess the safety and efficacy of EXPAREL when administered via infiltration into the transversus abdominis plane (TAP) to prolonged postsurgical analgesia in men undergoing robot-assisted laparoscopic prostatectomy.
Detailed description
Assess the safety and efficacy of EXPAREL when administered via infiltration into the transversus abdominis plane (TAP) to provide prolonged postsurgical analgesia in men undergoing robot-assisted laparoscopic prostatectomy. The primary endpoint is the duration of abdominal analgesia from the infiltration into the TAP as measured by the time to the subject's first postsurgical opioid administration.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| EXPAREL 20 mL (undiluted) | Experimental | Drug: EXPAREL 20 mL20 mL (266 mg) undiluted EXPAREL with 133 mg infiltrated on each the right and left side of the abdomen. |
| EXPAREL 40 mL (diluted) | Active comparator | Drug: EXPAREL 40 mL20 mL (266 mg) EXPAREL diluted with an equal volume of preservative-free 0.9% normal saline to a total of 40 mL and infiltrated equally to the right and left side of the abdomen. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- male subjects, aged 18-75.
- American Society of Anesthesiology (ASA) physical status 1-3.
- Undergoing robot-assisted laparoscopic prostatectomy performed by a single surgeon (Ingolf Tuerk, MD).
- Subjects must be physically and mentally able to participate in the study and complete all study assessments.
- Subjects must be able to give fully informed consent to participate in this study after demonstrating a good understanding of the risks and benefits of the TAP infiltration.
Key exclusion criteria (5 listed)
- Demonstrated hypersensitivity or idiosyncratic reactions to amide-type local anesthetics.
- Inability to tolerate oxycodone with acetaminophen (e.g. Percocet).
- 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.
- 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 |
|---|---|---|
| EXPAREL 20 mLAlso: bupivacaine liposome injectable suspensionEXPAREL 266 mg (undiluted) | Drug | EXPAREL 20 mL (undiluted) |
| EXPAREL 40 mLAlso: bupivacaine liposome injectable suspensionEXPAREL 266 mg diluted with preservative-free 0.9% normal saline to 40 mL. | Drug | EXPAREL 40 mL (diluted) |
Primary outcome
The Duration of Abdominal Analgesia From Infiltration Into the TAP
Time frame: First postsurgical administration of an opioid
5 secondary outcomes
Subject Reported Postsurgical Pain
Time frame: 1, 2, 6, 12, 24, 48, 72, 96 hours and 10 days after TAP
Physician/Healthcare Professional Assessed Postsurgical Pain
Time frame: 1, 2, 6, 12, 24 hours after TAP
Total Postsurgical Oxycodone/Acetaminophen Consumption From Hospital Discharge Through Hour 96.
Time frame: 48, 72, 96 hours
Incidence of Prespecified Opioid-related Adverse Events
Time frame: Until hospital discharge order was written, anticipated at 24 hours.
Overall Rating of Subject Satisfaction With Postsurgical Pain Control
Time frame: 24 hours, 72 hours, and day 10
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jun 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.
Andrew Sternlicht, MD principal investigator
Steward St. Elizabeth's
1 site 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 20 mL and EXPAREL 40 mL in people with Postsurgical Pain and Analgesia, run by Pacira Pharmaceuticals, Inc at 1 site 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 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: finished, as of the sponsor's last update on 14 Jun 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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. 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 10 Jun 2013). 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?
The Duration of Abdominal Analgesia From Infiltration Into the TAP (time frame: First postsurgical administration of an opioid). 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 14 Jun 2021.