Ovarian CancerPhase 3NCT04849858
Pilot Study of Liposomal Bupivacaine Redosing in Patients Undergoing Major Gynecologic Procedures
A Phase 3 study testing Bupivacaine and Liposomal bupivacaine in people with Ovarian Cancer and Fibroids, run by University of California, Irvine at 1 site in United States.
Trial summary
The purpose of this research study is to find out which type of transversus abdomens plane (TAP) and block (bupivacaine, liposomal bupivacaine or liposomal bupivacaine with re-dosing at 48-60 hours) improves your pain control and lowers your risk of post-operative common side effects of surgery and narcotic pain… Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Ovarian Cancer, Fibroids, Uterine Cancer
- What is being tested?
- Bupivacaine and Liposomal bupivacaine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 13 participants
- Where
- 1 siteUnited States
- Study dates
- 20 May 2019to 13 Jan 2023
- Phase
- Phase 3
- Are there results?
- None posted in the registry
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
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥ 18 years old
- Must be undergoing an open gynecologic procedure through a midline vertical incision with a gynecologic oncologist
Who cannot join
- History of chronic pain
- History of opioid dependence
- Suspected or confirmed history of endometriosis
- History of fibromyalgia
- Suspected or confirmed interstitial cystitis or painful bladder syndrome
- History of or current opioid use prior to surgery
- Hypersensitivity to bupivacaine
- Severe hepatic or renal disease
Trial locations and contacts
1 site in 1 country.
United States1 site
University of California, Irvine
Orange, California, 92868
About this study
Official title: Pilot Study of Liposomal Bupivacaine Redosing in Patients Undergoing Major Gynecologic Procedures: A Quality Improvement Project in Post-operative Pain
The purpose of this research study is to find out which type of transversus abdomens plane (TAP) and block (bupivacaine, liposomal bupivacaine or liposomal bupivacaine with re-dosing at 48-60 hours) improves your pain control and lowers your risk of post-operative common side effects of surgery and narcotic pain medications.
Read the detailed description
The purpose of this research study is to find out which type of TAP block (bupivacaine, liposomal bupivacaine or liposomal bupivacaine with re-dosing at 48-60 hours) improves your pain control and lowers your risk of post-operative common side effects of surgery and narcotic pain medications.
An anesthesiologist participating on this study will describe the TAP block to you during your preoperative interview and will obtain your consent for the block procedure with your anesthesia consent prior to the procedure. TAP blocks are one of the various methods of controlling your pain after surgery. They are typically placed with an anesthetic agent, such as bupivacaine. The U.S. Food and Drug Administration (FDA) has recently approved a longer-acting form of the anesthetic used in this study, liposomal bupivacaine. Although both medications, bupivacaine and liposomal bupivacaine are approved by the FDA, there are only a few trials such as this one, in the United States, comparing the various types of TAP blocks. No studies exist comparing the re-dosing of a TAP block, as we will be doing in this study.
Currently, the standard of care after a gynecologic procedure may or may not include receiving a TAP block. This was a decision typically made, with your consent, at the discretion of an anesthesiologist and your surgeon. As per the standard of care, after surgery, you would be given oral pain medications to control your pain and intravenous pain medications for severe breakthrough pain. Our study will not change your post-operative pain medication schedule or timing. It will only study the effectiveness of the TAP block you get in controlling your pain.
Even though the medicines (bupivacaine or liposomal bupivacaine) used in this study are FDA-approved, the use of these drugs in this study is investigational.
- Conditions
- Ovarian Cancer, Fibroids, Uterine Cancer
- Being tested
- Bupivacaine, Liposomal bupivacaine
- Keywords
- ovarian cancer, fibroids, uterine cancer, Transverse abdominis plane block, TAP block
- Medical subject headings
- Ovarian Neoplasms, Leiomyoma, Uterine Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BupivacaineDrug
Participants in this group will receive a TAP block using the drug Bupivacaine.
Liposomal bupivacaineDrug
Participants in this group will receive a TAP block using the drug Liposomal Bupivacaine.
Liposomal bupivacaineDrug
Also called With Re-dosing
Participants in this group will receive a TAP block using the drug Liposomal Bupivacaine followed by a re-dosing during their hospitalization
| Study group | Role | What they receive |
|---|---|---|
| Bupivacaine TAP Block | Active comparator | The first 15 patients enrolled will receive perioperative plain bupivacaine TAP blocks. Receives: Drug: Bupivacaine |
| Liposomal Bupivacaine TAP Block | Active comparator | After enrolling all 15 participants in the first arm, the next 15 patients enrolled will receive perioperative single-dose Liposomal Bupivacaine TAP blocks. Receives: Drug: Liposomal bupivacaine |
| Liposomal Bupivacaine TAP Block with Re-dosing | Active comparator | After enrolling all 30 patients in the first two arms, the final 15 patients enrolled will receive perioperative Liposomal Bupivacaine TAP blocks followed by redosing of the TAP blocks in 48-60 hours. Receives: Drug: Liposomal bupivacaine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Post-operative opioid consumption
Morphine equivalents (milligrams)
Measured: Post-operative day 0 to day 8
Secondary outcomes (7)
Pain at rest and during activity
Measured pain on a Visual Analog Scale (VAS), Scale 0 (no pain) - 10 (high pain)
Measured: Post-operative day 0 to day 8
Nausea/Vomiting
Presence or Absence of nausea or vomiting
Measured: Post-operative day 0 to day 8
Ileus
Presence or Absence of Ileus
Measured: Post-operative day 0 to day 8
Bowel Function
Time to return of bowel function (days)
Measured: Post-operative day 0 to day 8
Ambulation
Time to first ambulation (days)
Measured: Post-operative day 0 to day 8
Hospital stay
Length of hospital stay (days)
Measured: Post-operative day 0 to day 8
Surgical Adverse Events
Presence or Absence of adverse events
Measured: Post-operative day 0 to day 8
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Apr 2021
- Study start20 May 2019
- Primary completion13 Jan 2023
- Study completion13 Jan 2023
Why it stopped: Low recruitment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ovarian CancerStudies of the same condition, open and under way.
- More trials run by University of California, IrvineThe sponsor's other registered studies.
- 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 3
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Model description
- This is a prospective cohort study with retrospective data analysis. Patients will be assigned to treatment groups on a consecutive basis. We will be recruiting 45 eligible patients from our University of California Irvine (UCI) gynecologic oncology clinic. Each clinic patient who is scheduled for surgery will be screened for eligibility. The first 15 patients enrolled will receive perioperative plain bupivacaine transversus abdominis plane (TAP) blocks. The next 15 patients enrolled will receive perioperative single-dose Liposomal Bupivacaine (LB) TAP blocks. The final 15 patients enrolled will receive perioperative LB TAP blocks followed by redosing of the TAP blocks in 48-60 hours.
- Masking
- None (open label)
- Enrolment
- 13 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, Irvine
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jill Tseng, University of California, Irvine
- Investigators
- Jill H Tseng, MD, Principal investigator, University of California, Irvine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04849858
- Sponsor's protocol ID
- 20194981
- Other IDs
- UCI 19-16
- Status last verified
- Aug 2024
- First submitted
- 16 Apr 2021
- Last updated
- 23 Aug 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study of Liposomal Bupivacaine Redosing in Patients Undergoing Major Gynecologic Procedures: A Quality Improvement Project in Post-operative Pain
- ClinicalTrials.gov ID
- NCT04849858
- Acronym / sponsor ID
- 20194981
- Conditions
- Ovarian Cancer, Fibroids, Uterine Cancer
- Keywords
- ovarian cancer, fibroids, uterine cancer, Transverse abdominis plane block, TAP block
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Low recruitment
- Enrolment
- 13 participants (actual)
- Lead sponsor
- University of California, IrvineUniversity, hospital or other
- Study start
- 20 May 2019 (actual)
- Primary completion
- 13 Jan 2023 (actual)
- Study completion
- 13 Jan 2023 (actual)
- First posted
- 19 Apr 2021 (actual)
- Results
- Not posted in the source record
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 research study is to find out which type of transversus abdomens plane (TAP) and block (bupivacaine, liposomal bupivacaine or liposomal bupivacaine with re-dosing at 48-60 hours) improves your pain control and lowers your risk of post-operative common side effects of surgery and narcotic pain medications.
Detailed description
The purpose of this research study is to find out which type of TAP block (bupivacaine, liposomal bupivacaine or liposomal bupivacaine with re-dosing at 48-60 hours) improves your pain control and lowers your risk of post-operative common side effects of surgery and narcotic pain medications.
An anesthesiologist participating on this study will describe the TAP block to you during your preoperative interview and will obtain your consent for the block procedure with your anesthesia consent prior to the procedure. TAP blocks are one of the various methods of controlling your pain after surgery. They are typically placed with an anesthetic agent, such as bupivacaine. The U.S. Food and Drug Administration (FDA) has recently approved a longer-acting form of the anesthetic used in this study, liposomal bupivacaine. Although both medications, bupivacaine and liposomal bupivacaine are approved by the FDA, there are only a few trials such as this one, in the United States, comparing the various types of TAP blocks. No studies exist comparing the re-dosing of a TAP block, as we will be doing in this study.
Currently, the standard of care after a gynecologic procedure may or may not include receiving a TAP block. This was a decision typically made, with your consent, at the discretion of an anesthesiologist and your surgeon. As per the standard of care, after surgery, you would be given oral pain medications to control your pain and intravenous pain medications for severe breakthrough pain. Our study will not change your post-operative pain medication schedule or timing. It will only study the effectiveness of the TAP block you get in controlling your pain.
Even though the medicines (bupivacaine or liposomal bupivacaine) used in this study are FDA-approved, the use of these drugs in this study is investigational.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- This is a prospective cohort study with retrospective data analysis. Patients will be assigned to treatment groups on a consecutive basis. We will be recruiting 45 eligible patients from our University of California Irvine (UCI) gynecologic oncology clinic. Each clinic patient who is scheduled for surgery will be screened for eligibility. The first 15 patients enrolled will receive perioperative plain bupivacaine transversus abdominis plane (TAP) blocks. The next 15 patients enrolled will receive perioperative single-dose Liposomal Bupivacaine (LB) TAP blocks. The final 15 patients enrolled will receive perioperative LB TAP blocks followed by redosing of the TAP blocks in 48-60 hours.
| Arm | Type | Receives |
|---|---|---|
| Bupivacaine TAP Block | Active comparator | Drug: BupivacaineThe first 15 patients enrolled will receive perioperative plain bupivacaine TAP blocks. |
| Liposomal Bupivacaine TAP Block | Active comparator | Drug: Liposomal bupivacaineAfter enrolling all 15 participants in the first arm, the next 15 patients enrolled will receive perioperative single-dose Liposomal Bupivacaine TAP blocks. |
| Liposomal Bupivacaine TAP Block with Re-dosing | Active comparator | Drug: Liposomal bupivacaineAfter enrolling all 30 patients in the first two arms, the final 15 patients enrolled will receive perioperative Liposomal Bupivacaine TAP blocks followed by redosing of the TAP blocks in 48-60 hours. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Age ≥ 18 years old
- Must be undergoing an open gynecologic procedure through a midline vertical incision with a gynecologic oncologist
Key exclusion criteria (8 listed)
- History of chronic pain
- History of opioid dependence
- Suspected or confirmed history of endometriosis
- History of fibromyalgia
- Suspected or confirmed interstitial cystitis or painful bladder syndrome
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 |
|---|---|---|
| BupivacaineParticipants in this group will receive a TAP block using the drug Bupivacaine. | Drug | Bupivacaine TAP Block |
| Liposomal bupivacaineParticipants in this group will receive a TAP block using the drug Liposomal Bupivacaine. | Drug | Liposomal Bupivacaine TAP Block |
| Liposomal bupivacaineAlso: With Re-dosingParticipants in this group will receive a TAP block using the drug Liposomal Bupivacaine followed by a re-dosing during their hospitalization | Drug | Liposomal Bupivacaine TAP Block with Re-dosing |
Primary outcome
Post-operative opioid consumption
Time frame: Post-operative day 0 to day 8
Morphine equivalents (milligrams)
7 secondary outcomes
Pain at rest and during activity
Time frame: Post-operative day 0 to day 8
Nausea/Vomiting
Time frame: Post-operative day 0 to day 8
Ileus
Time frame: Post-operative day 0 to day 8
Bowel Function
Time frame: Post-operative day 0 to day 8
Ambulation
Time frame: Post-operative day 0 to day 8
Hospital stay
Time frame: Post-operative day 0 to day 8
Surgical Adverse Events
Time frame: Post-operative day 0 to day 8
Results and safety
The study was stopped early (reason given: Low recruitment). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Aug 2024.
- 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.
Jill H Tseng, MD principal investigator
University of California, Irvine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Bupivacaine and Liposomal bupivacaine in people with Ovarian Cancer and Fibroids, run by University of California, Irvine 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 8 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 23 Aug 2024. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Low recruitment). Results are not available in the source record.
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?
Post-operative opioid consumption (time frame: Post-operative day 0 to day 8). 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 23 Aug 2024.