Using liposomal bupivacaine for pain management in myomectomy surgery
Effect of Transversus Abdominal Plane Block Using Liposomal Bupivacaine Versus Standard Bupivacaine for Open Myomectomy: a Prospective Randomized Control Trial
PHASE4 · Icahn School of Medicine at Mount Sinai · NCT04272086
This study is testing whether a new form of pain relief called liposomal bupivacaine can help women having myomectomy surgery feel less pain and use fewer opioids afterward compared to the standard version.
Quick facts
| Phase | PHASE4 |
|---|---|
| Study type | Interventional |
| Enrollment | 140 (estimated) |
| Ages | 18 Years to 64 Years |
| Sex | Female |
| Sponsor | Icahn School of Medicine at Mount Sinai (other) |
| Locations | 1 site (New York, New York) |
| Trial ID | NCT04272086 on ClinicalTrials.gov |
What this trial studies
This study investigates the effectiveness of liposomal bupivacaine compared to standard bupivacaine in providing pain relief for patients undergoing open myomectomy. Patients will be randomly assigned to receive either type of local anesthetic through a transversus abdominal plane block before surgery. The primary focus is to analyze the impact on opioid consumption post-operatively, alongside secondary outcomes such as pain scores and recovery metrics. The study aims to enhance recovery protocols by optimizing pain management strategies.
Who should consider this trial
Good fit: Ideal candidates are women over 50kg who are not pregnant and are scheduled for open myomectomy.
Not a fit: Patients with a history of drug or alcohol abuse, chronic pain syndromes unrelated to myomas, or certain medical conditions may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly reduce opioid consumption and improve pain management for patients undergoing myomectomy.
How similar studies have performed: Other studies have shown promising results with liposomal bupivacaine in various surgical settings, suggesting potential for success in this application.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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.
Where this trial is running
New York, New York
- Icahn School of Medicine at Mount Sinai — New York, New York, United States (RECRUITING)
Study contacts
- Principal investigator: Daniel Katz, MD — Icahn School of Medicine at Mount Sinai
- Study coordinator: Daniel Katz, MD
- Email: daniel.katz@mountsinai.org
- Phone: 212-241-7475
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Fibroid Uterus, Fibroid uterus, Myomectomy, Abdominal myomectomy