Clinical trial · Interventional
Utility of Liposomal Bupivacaine Transversus Abdominal Plane Block for Open Myomectomy
Effect of Transversus Abdominal Plane Block Using Liposomal Bupivacaine Versus Standard Bupivacaine for Open Myomectomy: A Prospective Randomized Control Trial
NCT04272086CI-TRIAL-00097154completedPhase 4ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Fibroid Uterus | Uterine Corpus Leiomyoma | ALIAS | 0.90 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Bupivacaine | Drug | — | UNRESOLVED |
| Bupivacaine liposome | Drug | — | UNRESOLVED |
| normal saline | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- PLACEBO_COMPARATOR
- label
- Bupivacaine TAP
- description
- TAP block with 30 mL 0.25% bupivacaine mixed with 10 mL normal saline for a total of 40 mL per side
- interventionNames
- Drug: Bupivacaine
- Drug: normal saline
- type
- EXPERIMENTAL
- label
- Liposomal bupivacaine TAP
- description
- TAP block with 10mL liposomal bupivacaine, 20mL 0.25% bupivacaine, and 10mL normal saline for a total of 40 mL per side
- interventionNames
- Drug: Bupivacaine
- Drug: Bupivacaine liposome
- Drug: normal saline
Primary outcomes (1)
- measure
- Morphine Equivalents at 72 Hours
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 64 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available
No reference posted for this study.