Fibroid UterusPhase 4NCT04272086
Utility of Liposomal Bupivacaine Transversus Abdominal Plane Block for Open Myomectomy
A Phase 4 study testing Bupivacaine, Bupivacaine liposome and normal saline in people with Fibroid Uterus, run by Icahn School of Medicine at Mount Sinai at 1 site in United States.
Trial summary
The study team will be randomizing patients presenting for open myomectomy to either received transversus abdominal plane blocks with either liposomal bupivacaine or standard bupivacaine. Read more about this study
- Who is it for?
- Ages 18 to 64 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Fibroid Uterus
- What is being tested?
- Bupivacaine, Bupivacaine liposome and normal saline
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 140 participants
- Where
- 1 siteUnited States
- Study dates
- 9 Nov 2020to 28 Oct 2025
- Phase
- Phase 4
- 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 to 64 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Not pregnant
- Weight over 50kg presenting for open myomectomy
- No history of allergy to any study medication
- No history of malignant ventricular dysrhythmia, epilepsy, seizure disorder, or chronic pain syndrome other than pain from myomas
- No history of drug or alcohol use or abuse disorder or pre-existing liver disease.
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
United States1 site
Icahn School of Medicine at Mount Sinai
New York, New York, 10029
About this study
Official title: Effect of Transversus Abdominal Plane Block Using Liposomal Bupivacaine Versus Standard Bupivacaine for Open Myomectomy: A Prospective Randomized Control Trial
The study team will be randomizing patients presenting for open myomectomy to either received transversus abdominal plane blocks with either liposomal bupivacaine or standard bupivacaine. The study team will be analyzing the impact of local anesthetic on opiate consumption as the investigator's primary endpoint with other secondary endpoints.
Read the detailed description
After consent, patients will be randomized to either liposomal bupivacaine Transversus Abdominal Plane (TAP) vs standard bupivacaine TAP. Blocks will occur post induction and pre incision. Only the block team (not the anesthesia team nor the care team) will be unblinded and they will not have any impact on the data collection. The entire care team and the patient will be blinded. A standardized anesthetic regimen will be employed followed by a prescriptive post-operative pain management plan aimed at enhanced recovery. Patients will be followed for up to 96 hours and asked about their opiate consumption, pain scores, side effects, and recovery.
- Conditions
- Fibroid Uterus
- Being tested
- Bupivacaine, Bupivacaine liposome, normal saline
- Keywords
- Fibroid uterus, Myomectomy, Abdominal myomectomy
- Medical subject headings
- Leiomyoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BupivacaineDrug
0.25%
Bupivacaine liposomeDrug
10mL
normal salineDrug
10ml
| Study group | Role | What they receive |
|---|---|---|
| Bupivacaine TAP | Placebo comparator | TAP block with 30 mL 0.25% bupivacaine mixed with 10 mL normal saline for a total of 40 mL per side Receives: Drug: Bupivacaine; Drug: normal saline |
| Liposomal bupivacaine TAP | Experimental | TAP block with 10mL liposomal bupivacaine, 20mL 0.25% bupivacaine, and 10mL normal saline for a total of 40 mL per side Receives: Drug: Bupivacaine; Drug: Bupivacaine liposome; Drug: normal saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
Morphine Equivalents at 72 Hours
Total cumulative opiates consumed converted to morphine equivalents
Measured: 72 hours
Secondary outcomes (6)
Morphine Equivalents at 96 Hours
Total cumulative opiates consumed converted to morphine equivalents
Measured: 96 hours
Morphine Equivalents at 48 Hours
Total cumulative opiates consumed converted to morphine equivalents
Measured: 48 hours
Opiate Sparing Criteria at 72 hours
Composite score of minimal opiate dose and additionally scores of 0 on questions 2,3,4,5,6 on OBAS scoring scale.
Overall Benefit of Analgesic Score (OBAS) scoring scale -total scale from 0-20, low score indicates high benefit.
Measured: 72 hours
Quality of Recovery at 48 hours
15 question quality of recovery scale, full scale from 0-150, with lower score indicating better recovery.
Measured: 48 hours
Quality of Recovery at 72 hours
15 question quality of recovery scale, full scale from 0-150, with lower score indicating better recovery.
Measured: 72 hours
Area under the curve pain scale at 96 hours
Sum of pain scores at 24, 48, 72, and 96 hours. Pain scale from 0-10, with higher score indicating worst pain.
Measured: 96 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Feb 2020
- Study start9 Nov 2020
- Primary completion28 Oct 2025
- Study completion28 Oct 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Fibroid UterusStudies of the same condition, open and under way.
- More trials run by Icahn School of Medicine at Mount SinaiThe 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Double blind randomized control trial with intervention arm as liposomal bupivacaine tap and intervention as standard bupivacaine tap
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 140 participants (actual)
Sponsor and investigators
- Lead sponsor
- Icahn School of Medicine at Mount Sinai
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Daniel Katz, Icahn School of Medicine at Mount Sinai
- Investigators
- Daniel Katz, MD, Principal investigator, Icahn School of Medicine at Mount Sinai
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04272086
- Sponsor's protocol ID
- GCO 19-1807
- Status last verified
- Nov 2025
- First submitted
- 13 Feb 2020
- Last updated
- 12 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
- 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 12 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Transversus Abdominal Plane Block Using Liposomal Bupivacaine Versus Standard Bupivacaine for Open Myomectomy: A Prospective Randomized Control Trial
- ClinicalTrials.gov ID
- NCT04272086
- Acronym / sponsor ID
- GCO 19-1807
- Conditions
- Fibroid Uterus
- Keywords
- Fibroid uterus, Myomectomy, Abdominal myomectomy
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 140 participants (actual)
- Lead sponsor
- Icahn School of Medicine at Mount SinaiUniversity, hospital or other
- Study start
- 9 Nov 2020 (actual)
- Primary completion
- 28 Oct 2025 (actual)
- Study completion
- 28 Oct 2025 (actual)
- First posted
- 17 Feb 2020 (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 study team will be randomizing patients presenting for open myomectomy to either received transversus abdominal plane blocks with either liposomal bupivacaine or standard bupivacaine. The study team will be analyzing the impact of local anesthetic on opiate consumption as the investigator's primary endpoint with other secondary endpoints.
Detailed description
After consent, patients will be randomized to either liposomal bupivacaine Transversus Abdominal Plane (TAP) vs standard bupivacaine TAP. Blocks will occur post induction and pre incision. Only the block team (not the anesthesia team nor the care team) will be unblinded and they will not have any impact on the data collection. The entire care team and the patient will be blinded. A standardized anesthetic regimen will be employed followed by a prescriptive post-operative pain management plan aimed at enhanced recovery. Patients will be followed for up to 96 hours and asked about their opiate consumption, pain scores, side effects, and recovery.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Double blind randomized control trial with intervention arm as liposomal bupivacaine tap and intervention as standard bupivacaine tap
| Arm | Type | Receives |
|---|---|---|
| Bupivacaine TAP | Placebo comparator | Drug: Bupivacaine, Drug: normal salineTAP block with 30 mL 0.25% bupivacaine mixed with 10 mL normal saline for a total of 40 mL per side |
| Liposomal bupivacaine TAP | Experimental | Drug: Bupivacaine, Drug: Bupivacaine liposome, Drug: normal salineTAP block with 10mL liposomal bupivacaine, 20mL 0.25% bupivacaine, and 10mL normal saline for a total of 40 mL per side |
Who may qualify
- Ages
- 18 to 64 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Not pregnant
- Weight over 50kg presenting for open myomectomy
- No history of allergy to any study medication
- No history of malignant ventricular dysrhythmia, epilepsy, seizure disorder, or chronic pain syndrome other than pain from myomas
- No history of drug or alcohol use or abuse disorder or pre-existing liver disease.
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| Bupivacaine0.25% | Drug | Bupivacaine TAP, Liposomal bupivacaine TAP |
| Bupivacaine liposome10mL | Drug | Liposomal bupivacaine TAP |
| normal saline10ml | Drug | Bupivacaine TAP, Liposomal bupivacaine TAP |
Primary outcome
Morphine Equivalents at 72 Hours
Time frame: 72 hours
Total cumulative opiates consumed converted to morphine equivalents
6 secondary outcomes
Morphine Equivalents at 96 Hours
Time frame: 96 hours
Morphine Equivalents at 48 Hours
Time frame: 48 hours
Opiate Sparing Criteria at 72 hours
Time frame: 72 hours
Quality of Recovery at 48 hours
Time frame: 48 hours
Quality of Recovery at 72 hours
Time frame: 72 hours
Area under the curve pain scale at 96 hours
Time frame: 96 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Nov 2025.
- 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.
Daniel Katz, MD principal investigator
Icahn School of Medicine at Mount Sinai
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 Bupivacaine, Bupivacaine liposome and normal saline in people with Fibroid Uterus, run by Icahn School of Medicine at Mount Sinai 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 0 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 12 Nov 2025. 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. Some participants in this study may receive a placebo. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Morphine Equivalents at 72 Hours (time frame: 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 12 Nov 2025.