Postoperative PainPhase 4NCT02263963
The Transversus Abdominis Plane Block: A Prospective Randomized Clinical Trial Using EXPAREL.
A Phase 4 study testing Exparel and TAP Block in people with Postoperative Pain, run by Corewell Health West at 1 site in United States.
Trial summary
The purpose of the study is to evaluate the effectiveness of EXPAREL in a transversus abdominis plane block by assessing the demand of postoperative narcotic, length of hospital stay and incidence of postoperative complications. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Postoperative Pain
- What is being tested?
- Exparel and TAP Block
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2013to Nov 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
- Patients over the age of 18 years w
- Elective laparoscopic colorectal resection.
Who cannot join
- Patients under 18 years.
- Patients unable to provide informed consent
- Patients undergoing emergency surgery.
- Pregnant women
- Severe liver or kidney disease (GFR 15-29 ml/min)
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of the study is to evaluate the effectiveness of EXPAREL in a transversus abdominis plane block by assessing the demand of postoperative narcotic, length of hospital stay and incidence of postoperative complications.
- Conditions
- Postoperative Pain
- Being tested
- Exparel, TAP Block
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ExparelDrug
In this arm as described above the intervention will be TAP block injection under ultrasound guidance using Exparel.
TAP BlockProcedure or surgery
no intervention will be done to this arm.
| Study group | Role | What they receive |
|---|---|---|
| TAP Block Experal | Experimental | Patient who randomized to this arm, will be blinded, TAP block will be performed under ultrasound guidance, where 20-30 ml of Exparel will be injected in transversus abdominis plane, bilaterally. Receives: Drug: Exparel; Procedure: TAP Block |
| No TAP Block | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative Pain Score
Patient will be evaluate for their post operative pain by nurses using visual analog scale from 0 to 10, zero means no pain, 10 is the worst pain can patient ever experience.
Measured: participants will be followed for the duration of hospital stay, an expected average of 4 days
Secondary outcomes (1)
Postoperative Narcotic Use
Will be measured, by converting all narcotic medicine used during postoperative period to equal morphine in mg, a calculator created by our pharmacy expert is able to convert any narcotic medicine such as fentanyl, oxycodone, hydromorphone, to morphine in mg. By doing that will have one variable to compare to the two groups.
Measured: participants will be followed for the duration of hospital stay, an expected average of 4 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Oct 2014 (estimated)
- Study startJul 2013
- Primary completionNov 2014
- Study completionNov 2014
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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Corewell Health West
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02263963
- Sponsor's protocol ID
- 2013-066
- Other IDs
- DDI.FY13.07
- Status last verified
- Jan 2023
- First submitted
- 2 Dec 2013
- Last updated
- 28 Feb 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 28 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Transversus Abdominis Plane Block: A Prospective Randomized Clinical Trial Using EXPAREL.
- ClinicalTrials.gov ID
- NCT02263963
- Acronym / sponsor ID
- 2013-066
- Conditions
- Postoperative Pain
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Corewell Health WestUniversity, hospital or other
- Study start
- Jul 2013
- Primary completion
- Nov 2014 (actual)
- Study completion
- Nov 2014 (actual)
- First posted
- 15 Oct 2014 (estimated)
- Results
- Posted 28 Feb 2023
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 evaluate the effectiveness of EXPAREL in a transversus abdominis plane block by assessing the demand of postoperative narcotic, length of hospital stay and incidence of postoperative complications.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| TAP Block Experal | Experimental | Drug: Exparel, Procedure: TAP BlockPatient who randomized to this arm, will be blinded, TAP block will be performed under ultrasound guidance, where 20-30 ml of Exparel will be injected in transversus abdominis plane, bilaterally. |
| No TAP Block | No intervention | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients over the age of 18 years w
- Elective laparoscopic colorectal resection.
Key exclusion criteria (5 listed)
- Patients under 18 years.
- Patients unable to provide informed consent
- Patients undergoing emergency surgery.
- Pregnant women
- Severe liver or kidney disease (GFR 15-29 ml/min)
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 |
|---|---|---|
| ExparelIn this arm as described above the intervention will be TAP block injection under ultrasound guidance using Exparel. | Drug | TAP Block Experal |
| TAP Blockno intervention will be done to this arm. | Procedure or surgery | TAP Block Experal |
Primary outcome
Postoperative Pain Score
Time frame: participants will be followed for the duration of hospital stay, an expected average of 4 days
Patient will be evaluate for their post operative pain by nurses using visual analog scale from 0 to 10, zero means no pain, 10 is the worst pain can patient ever experience.
1 secondary outcome
Postoperative Narcotic Use
Time frame: participants will be followed for the duration of hospital stay, an expected average of 4 days
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Feb 2023.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
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 and TAP Block in people with Postoperative Pain, run by Corewell Health West 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 2 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 28 Feb 2023. 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 28 Feb 2023). 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?
Postoperative Pain Score (time frame: participants will be followed for the duration of hospital stay, an expected average of 4 days). 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 28 Feb 2023.