PainPhase 4TapBlockNCT02179892
Comparison of Exparel to Bupivacaine With Dexamethasone in TAP Block
A Phase 4 study testing Bupivacaine Extended-Release Liposome Injection (Exparel), Bupivacaine and Dexamethasone Injection and IV Acetaminophen in people with Pain, run by Colette Curtis MD at 2 sites in United States.
Trial summary
The purpose of this study is to compare the efficacy and duration of bupivacaine extended-release liposome injection (Exparel) versus bupivacaine with dexamethasone in transversus abdominis plane (TAP) blocks for patients undergoing abdominal surgery at Emory University Hospital and Emory University Hospital Midtown. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pain
- What is being tested?
- Bupivacaine Extended-Release Liposome Injection (Exparel), Bupivacaine and Dexamethasone Injection and IV Acetaminophen
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 9 participants
- Where
- 2 sitesUnited States
- Study dates
- Jul 2014to 6 Jun 2015
- 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
- Male and female patients undergoing scheduled abdominal surgery at Emory University Hospital or Emory University Hospital Midtown
- Patients willing and able to provide written informed consent
Who cannot join
- Patients less than 18 years of age, since Exparel has not been studied in this age group
- Patients who are pregnant or lactating, since Exparel has not been shown to be safe in this population, and because of potential drug transfer to child
- Patients with uncontrolled diabetes since dexamethasone may cause hyperglycemia
- Patients with liver dysfunction, since bupivacaine is hepatically metabolized
- Patients with renal failure, since bupivacaine is renally excreted, defined as requiring hemodialysis or renal replacement therapy
- Patients with allergy to one of the study drugs
Show all 9Show fewer
- Patients with local infection, which may be exacerbated by dexamethasone
- Patients with significant opioid tolerance, defined as taking at least 60 mg oral morphine per day, 3 mg oral oxycodone per day, 25 mcg/hr fentanyl patch, 25 mg oral oxymorphone per day, 8 mg of oral hydromorphone per day or an equianalgesic dose of another opioid for one week or longer
- Patients with known coagulopathy, since bleeding risk is higher Patients who are getting neuraxial anesthesia for surgery
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Emory University Hospital Midtown
Atlanta, Georgia, 30308
Emory University Hospital
Atlanta, Georgia, 30322
About this study
Official title: Comparison Between Bupivacaine Extended-Release Liposome Injection (Exparel) Versus Bupivacaine With Dexamethasone in Transversus Abdominis Plane Block: A Prospective Randomized Controlled Trial
The purpose of this study is to compare the efficacy and duration of bupivacaine extended-release liposome injection (Exparel) versus bupivacaine with dexamethasone in transversus abdominis plane (TAP) blocks for patients undergoing abdominal surgery at Emory University Hospital and Emory University Hospital Midtown.
The investigators hypothesize that Exparel will provide greater postoperative pain relief than bupivacaine with dexamethasone. The investigators plan to enroll up to 50 male and female subjects meeting inclusion and exclusion criteria who will be randomized to receive either Exparel (Group 1) or bupivacaine with epinephrine and dexamethasone (Group 2) in the TAP block to achieve at least 22 subjects in each group
Read the detailed description
Group 1 will be administered 266 mg of Exparel, diluted to 30 mL. Group 2 will be given 28 mL of 0.375% bupivacaine and 8mg/2 mL dexamethasone.Before injection of the study medication, 2mL of normal saline with be injected under ultrasound visualization to ensure needle tip is in the transversus abdominis plane.Randomization will occur following the written informed consent and prior to the start of the surgical procedure. Postoperatively, study patients will receive intravenous acetaminophen 1000mg every 8 hours for 3 doses, then oral acetaminophen 650mg every 6 hours. Subjects will also have patient-controlled analgesia (PCA) with morphine or hydromorphone. The research staff recording data will be blinded to the treatment group. Demographic data will be recorded, including age, date of birth, height and weight to ensure similarity between the two groups. A medical history will be obtained as well as surgical and anesthesia details. Study patients will be followed for 72 hours postoperatively to record the amount of opioid consumption, as well as other pain score data using the Visual Analogue Scale (VAS).The subject's participation will end 72 hours after surgery. A telephone interview will occur with the subject if hospital discharge occurs prior to 72 hours.
- Conditions
- Pain
- Being tested
- Bupivacaine Extended-Release Liposome Injection (Exparel), Bupivacaine and Dexamethasone Injection, IV Acetaminophen, Oral Acetaminophen
- Keywords
- anesthesia, surgery, pain
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bupivacaine Extended-Release Liposome Injection (Exparel)Drug
266mg/30mL of Exparel will be injected via unilateral TAP block
Bupivacaine and Dexamethasone InjectionDrug
As a combination injection, 28 ml of 0.375% bupivacaine and 8 mg/2ml of dexamethasone will be injected via unilateral TAP block.
IV AcetaminophenDrug
Intravenous (IV) acetaminophen 1000 mg every 8 hours for 8 doses.
Oral AcetaminophenDrug
Oral acetaminophen 650 mg every 6 hours.
| Study group | Role | What they receive |
|---|---|---|
| Group 1-Exparel | Active comparator | Bupivacaine Extended-Release Liposome Injection (Exparel)will be administered via TAP block procedure Receives: Drug: Bupivacaine Extended-Release Liposome Injection (Exparel); Drug: IV Acetaminophen; Drug: Oral Acetaminophen |
| Group 2-Bupivacaine and Dexamethasone IV | Active comparator | Bupivacaine and Dexamethasone Injection will be administered via TAP block procedure. Receives: Drug: Bupivacaine and Dexamethasone Injection; Drug: IV Acetaminophen; Drug: Oral Acetaminophen |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean Opioid Consumption
The investigators will collect the total amount of opioid consumption for the 72 hour post operative period in each group.
Measured: Post Surgery (Up to 72 Hours)
Secondary outcomes (3)
Mean Visual Analogue Scale (VAS) Pain Score at Rest
The VAS method of pain assessment (scale of 1- 10) will be used to measure the participant's pain level at rest each day during the 72 hours post surgical period. One represents the lowest level of pain and 10 represents the highest level of pain.
Measured: Post-Surgery 24 Hours, 48 Hours, 72 Hours
Mean Visual Analogue Scale (VAS) Pain Score With Movement
The VAS method of pain assessment (scale of 1-10) will be used to measure the patient's level of pain with movement each day during the 72 hour post surgical period. One represents the lowest level of pain and 10 represents the highest level of pain.
Measured: Post-Surgery 24 Hours, 48 Hours, 72 Hours
Mean Time of First Opioid Use
The time of first opioid use after surgery will be recorded for up to 72 hours.
Measured: Post-surgery (Up to 72 Hours)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jul 2014 (estimated)
- Study startJul 2014
- Primary completion6 Jun 2015
- Study completion6 Jun 2015
Why it stopped: Inadequate patient population to complete 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 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
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 9 participants (actual)
Sponsor and investigators
- Lead sponsor
- Colette Curtis MD
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Colette Curtis MD, Emory University
- Investigators
- Colette Curtis, MD, Principal investigator, Emory University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02179892
- Sponsor's protocol ID
- IRB00071635
- Acronym
- TapBlock
- Status last verified
- Jul 2017
- First submitted
- 30 Jun 2014
- Last updated
- 11 Aug 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison Between Bupivacaine Extended-Release Liposome Injection (Exparel) Versus Bupivacaine With Dexamethasone in Transversus Abdominis Plane Block: A Prospective Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT02179892
- Acronym / sponsor ID
- TapBlock / IRB00071635
- Conditions
- Pain
- Keywords
- anesthesia, surgery, pain
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Inadequate patient population to complete enrollment
- Enrolment
- 9 participants (actual)
- Lead sponsor
- Colette Curtis MDUniversity, hospital or other
- Study start
- Jul 2014
- Primary completion
- 6 Jun 2015 (actual)
- Study completion
- 6 Jun 2015 (actual)
- First posted
- 2 Jul 2014 (estimated)
- Results
- Posted 11 Aug 2017
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 study is to compare the efficacy and duration of bupivacaine extended-release liposome injection (Exparel) versus bupivacaine with dexamethasone in transversus abdominis plane (TAP) blocks for patients undergoing abdominal surgery at Emory University Hospital and Emory University Hospital Midtown.
The investigators hypothesize that Exparel will provide greater postoperative pain relief than bupivacaine with dexamethasone. The investigators plan to enroll up to 50 male and female subjects meeting inclusion and exclusion criteria who will be randomized to receive either Exparel (Group 1) or bupivacaine with epinephrine and dexamethasone (Group 2) in the TAP block to achieve at least 22 subjects in each group
Detailed description
Group 1 will be administered 266 mg of Exparel, diluted to 30 mL. Group 2 will be given 28 mL of 0.375% bupivacaine and 8mg/2 mL dexamethasone.Before injection of the study medication, 2mL of normal saline with be injected under ultrasound visualization to ensure needle tip is in the transversus abdominis plane.Randomization will occur following the written informed consent and prior to the start of the surgical procedure. Postoperatively, study patients will receive intravenous acetaminophen 1000mg every 8 hours for 3 doses, then oral acetaminophen 650mg every 6 hours. Subjects will also have patient-controlled analgesia (PCA) with morphine or hydromorphone. The research staff recording data will be blinded to the treatment group. Demographic data will be recorded, including age, date of birth, height and weight to ensure similarity between the two groups. A medical history will be obtained as well as surgical and anesthesia details. Study patients will be followed for 72 hours postoperatively to record the amount of opioid consumption, as well as other pain score data using the Visual Analogue Scale (VAS).The subject's participation will end 72 hours after surgery. A telephone interview will occur with the subject if hospital discharge occurs prior to 72 hours.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1-Exparel | Active comparator | Drug: Bupivacaine Extended-Release Liposome Injection (Exparel), Drug: IV Acetaminophen, Drug: Oral AcetaminophenBupivacaine Extended-Release Liposome Injection (Exparel)will be administered via TAP block procedure |
| Group 2-Bupivacaine and Dexamethasone IV | Active comparator | Drug: Bupivacaine and Dexamethasone Injection, Drug: IV Acetaminophen, Drug: Oral AcetaminophenBupivacaine and Dexamethasone Injection will be administered via TAP block procedure. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Male and female patients undergoing scheduled abdominal surgery at Emory University Hospital or Emory University Hospital Midtown
- Patients willing and able to provide written informed consent
Key exclusion criteria (9 listed)
- Patients less than 18 years of age, since Exparel has not been studied in this age group
- Patients who are pregnant or lactating, since Exparel has not been shown to be safe in this population, and because of potential drug transfer to child
- Patients with uncontrolled diabetes since dexamethasone may cause hyperglycemia
- Patients with liver dysfunction, since bupivacaine is hepatically metabolized
- Patients with renal failure, since bupivacaine is renally excreted, defined as requiring hemodialysis or renal replacement therapy
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 |
|---|---|---|
| Bupivacaine Extended-Release Liposome Injection (Exparel)266mg/30mL of Exparel will be injected via unilateral TAP block | Drug | Group 1-Exparel |
| Bupivacaine and Dexamethasone InjectionAs a combination injection, 28 ml of 0.375% bupivacaine and 8 mg/2ml of dexamethasone will be injected via unilateral TAP block. | Drug | Group 2-Bupivacaine and Dexamethasone IV |
| IV AcetaminophenIntravenous (IV) acetaminophen 1000 mg every 8 hours for 8 doses. | Drug | Group 1-Exparel, Group 2-Bupivacaine and Dexamethasone IV |
| Oral AcetaminophenOral acetaminophen 650 mg every 6 hours. | Drug | Group 1-Exparel, Group 2-Bupivacaine and Dexamethasone IV |
Primary outcome
Mean Opioid Consumption
Time frame: Post Surgery (Up to 72 Hours)
The investigators will collect the total amount of opioid consumption for the 72 hour post operative period in each group.
3 secondary outcomes
Mean Visual Analogue Scale (VAS) Pain Score at Rest
Time frame: Post-Surgery 24 Hours, 48 Hours, 72 Hours
Mean Visual Analogue Scale (VAS) Pain Score With Movement
Time frame: Post-Surgery 24 Hours, 48 Hours, 72 Hours
Mean Time of First Opioid Use
Time frame: Post-surgery (Up to 72 Hours)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Aug 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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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.
Colette Curtis, MD principal investigator
Emory University
2 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 Bupivacaine Extended-Release Liposome Injection (Exparel), Bupivacaine and Dexamethasone Injection and IV Acetaminophen in people with Pain, run by Colette Curtis MD at 2 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 2 inclusion and 9 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 11 Aug 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 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. 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 11 Aug 2017). 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?
Mean Opioid Consumption (time frame: Post Surgery (Up to 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 11 Aug 2017.