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Liposomal Bupivacaine + Standard Bupivacaine for Post-C-Section Pain
Study Summary
This trial compares the effect of two types of anesthetic drugs on pain relief after c-section delivery.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Trial Design
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Who is running the clinical trial?
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- I did not experience any major complications during surgery that made me medically unstable.I have a bleeding or clotting disorder with low platelets or high INR.I am not planning any surgery except for ovary removal or tubal ligation.I am not taking any medications that interact with bupivacaine.My spinal anesthesia was changed to general because it didn't work well.I am 37 weeks pregnant or more and scheduled for a cesarean delivery.My kidney or liver function is not severely impaired.I have had surgery with a horizontal cut near my bikini line.You have a history of using illegal drugs or abusing prescription medications in the past 2 years.You are pregnant and have a very high body mass index, or you are not suitable for a particular type of surgery.I will receive spinal anesthesia in a specific region.I am a woman aged 18 or older.My health is good to moderately impaired.I speak English or Spanish.I have a severe systemic disease that is a constant threat to my life.I am not allergic to the study medications or have manageable reactions.I have a long-term pain condition that needs opioids, not just from surgery.
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
- Drug Has Already Been Approved - The FDA has already approved this drug, and is just seeking more data.
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
Is Liposomal Bupivacaine + Bupivacaine HCL an unsafe option for patients?
"With a rating of 3, the safety of Liposomal Bupivacaine + Bupivacaine HCL is estimated to be high due to this treatment having reached Phase 4 trial and being approved."
Is enrollment for this research endeavor still open?
"As indicated on clinicaltrials.gov, this particular trial is not presently seeking participants. Initially posted in October of 2023 and recently updated in April of the same year, no further recruitment efforts are necessary at present. However, there are 636 other studies looking for enrollees as we speak."
Could you provide additional details about the results of prior experiments utilizing Liposomal Bupivacaine + Bupivacaine HCL?
"Presently, 97 clinical trials are underway for the combination drug Liposomal Bupivacaine + Bupivacaine HCL. Of those studies, 15 are in their concluding phase (Phase 3). The majority of these tests originate from Philadelphia, Pennsylvania, yet there exists a total of 131 separate sites running trials."
In what medical conditions can Liposomal Bupivacaine + Bupivacaine HCL be applied to alleviate symptoms?
"Liposomal Bupivacaine + Bupivacaine HCL is often prescribed to treat pemphigus. Additionally, this medication can be employed for acute nonspecific tenosynovitis, general anesthesia, and lupus erythematous cell ailments as well."
What is the cap on enrollment for this clinical trial?
"This study is no longer recruiting, as the last update was on April 20th of this year. If you are looking for other opportunities to participate in a clinical trial related to postoperative pain, there are 539 trials that need your help. Additionally, 97 studies require volunteers specifically interested in Liposomal Bupivacaine + Bupivacaine HCL treatments."
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