Pain relief shot for hysterectomy patients put on hold
NCT ID NCT05823363
First seen Jun 27, 2026 · Last updated Sep 18, 2026 · Updated 2 times
Summary
This study aimed to see if injecting Exparel (a long-acting painkiller) into the vaginal cuff before a minimally invasive hysterectomy could lower pain scores. Participants would have reported pain levels and medication use. However, the trial was withdrawn before any patients enrolled, so no data was collected.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Exparel (liposomal bupivacaine) mixed with bupivacaine
- What this could lead to
- If it worked, this could offer a way to reduce pain after hysterectomy without strong opioids.
- What could go wrong
- The trial was withdrawn before enrolling anyone, so no results are available. Even if run, it was a small Phase 4 study testing a known drug for a new use, so benefits may be modest.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 4
Runs after approval, following long-term safety and how well the treatment works in everyday use.
- Started
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Sep 2024
- Finished
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Sep 2024
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Female participants only
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * Any patient age \> 18 years who is having minimally invasive robotic or laparoscopic total hysterectomy for any indication without any anesthetic block. Exclusion Criteria: * 1\) Use of any of the following medications within the times specified before surgery: a. opioid, SSRI, tricyclic antidepressant, gabapentin, pregabalin within three days of surgery. b. Use of acetaminophen within 24 hours of surgery 2) Concurrent painful physical condition or concurrent surgery that may require analgesic treatment (such as NSAID, opioid, SSRI, tricyclic antidepressant, gabapentin, pregabalin) in the postoperative period for pain that is not strictly related to the minimally invasive supracervical hysterectomy procedure and may confound the postoperative assessments (e.g., rheumatoid arthritis, chronic neuropathic pain. 3\) Chronic user of analgesic medications, including taking opioid medications for more than 14 days in the last 3 months, or nonopioid pain medications more than 5 times per week. 4\) Current use of systemic glucocorticosteroids (e.g. Decadron) or use of glucocorticoids within one month of enrollment into this study. 5\) History of hepatitis (other than hepatitis A). 6) History of hypersensitivity or idiosyncratic reactions to amide type local anesthetics, opioids, or propofol. 7\) Administration of an investigational drug within 30 days prior to study drug administration, or planned administration of another investigational product or procedure during the subject's participation in this study. 8\) Uncontrolled anxiety, schizophrenia, or other psychiatric disorder that, in the opinion of the Investigator, may interfere with study assessments or compliance. 9\) Significant medical conditions or laboratory results that, in the opinion of the Investigator indicate an increased vulnerability to study drug and procedures, and expose subjects to an unreasonable risk as a result of participating in this clinical trial. 10\) Any clinically significant event or condition uncovered during the surgery (e.g., excessive bleeding, acute sepsis) that might render the subject medically unstable or complicate the subject's postoperative course. 11) women with endometriosis 12) contraindications to any medication used in the study (acetaminophen, NSAID or opioid).
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Maimonides Medical Center
Brooklyn, New York, 11219, United States
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