Clinical trial · Interventional
Pilot Study of Liposomal Bupivacaine Redosing in Patients Undergoing Major Gynecologic Procedures
Pilot Study of Liposomal Bupivacaine Redosing in Patients Undergoing Major Gynecologic Procedures: A Quality Improvement Project in Post-operative Pain
NCT04849858CI-TRIAL-00080106terminatedPhase 3ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Low recruitment
Summary
Brief summary (as posted)
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.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Fibroids | Leiomyoma | ALIAS | 0.90 |
| Ovarian Cancer | Malignant Ovarian Neoplasm | CURATED_EXACT | 0.92 |
| Uterine Cancer | Malignant Uterine Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Bupivacaine | Drug | — | UNRESOLVED |
| Liposomal bupivacaine | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (3)
- type
- ACTIVE_COMPARATOR
- label
- Bupivacaine TAP Block
- description
- The first 15 patients enrolled will receive perioperative plain bupivacaine TAP blocks.
- interventionNames
- Drug: Bupivacaine
- type
- ACTIVE_COMPARATOR
- label
- Liposomal Bupivacaine TAP Block
- description
- After enrolling all 15 participants in the first arm, the next 15 patients enrolled will receive perioperative single-dose Liposomal Bupivacaine TAP blocks.
- interventionNames
- Drug: Liposomal bupivacaine
- type
- ACTIVE_COMPARATOR
- label
- Liposomal Bupivacaine TAP Block with Re-dosing
- description
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria * Age ≥ 18 years old * Must be undergoing an open gynecologic procedure through a midline vertical incision with a gynecologic oncologist Exclusion Criteria * 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
References
Publications (0)
Data not yet available
No reference posted for this study.