Phase 4
Completed N=3
The Use Of Liposomal Bupivacaine For Pain Control
Pain, Breast
Source: ClinicalTrials.gov NCT03722927 ↗
Enrolled (actual)
3
Serious AEs
0.0%
Results posted
Oct 2022
Primary outcomePrimary: Mean Visual Analog Scores — 4; 3.5; 4; 3.5 score on a scale
◆ Published Evidence
No publication linked
No peer-reviewed publication reporting this trial's results has been linked yet. This can indicate results are unpublished — a known publication-bias signal. We re-check periodically.
Summary
The purpose of this research study is to determine how well the local anesthetic, liposomal bupivacaine, controls postoperative pain after mastectomy and breast reconstruction.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Mean Visual Analog Scores |
4; 3.5; 4; 3.5; 2 | — |
| SECONDARY Area Under the Curve Visual Analog Scores (Submuscular Augmentation Mammoplasty) |
— | — |
| SECONDARY Number of Morphine Doses Across All Subjects |
0; 20 | — |
| SECONDARY Length of Stay for Hospitalization |
1; 1 | — |
| SECONDARY Readmission Rates to the Hospital |
0; 0 | — |
| SECONDARY Frequency of Postoperative Opioid Related Adverse Effects |
0; 0 | — |
| SECONDARY Pain Intensity With Movement |
— | — |
Eligibility Criteria
Inclusion Criteria
- All patients who receive a bilateral mastectomy with immediate sub-pectoral implant based breast reconstruction
- Age ≥ 18 years
- Ability to understand and the willingness to sign an (Institutional Review Board) IRB-approved informed consent document.
- Patients who receive tissue expander placement or direct permanent implant placement will be included in the study.
Exclusion Criteria
- Patients who receive an autologous tissue reconstruction.
- Patients who receive a unilateral reconstruction.
- Patients who are expected to undergo axillary lymph node dissection
- Patients who have undergone breast irradiation
- Patients who abuse narcotics or have chronic pain (using greater than 40 mg equivalents of oxycodone per day)
- Patients who are wards of the state
- History of allergic reactions attributed to compounds of similar chemical or biologic composition to bupivacaine or liposomal bupivacaine.
- Pregnant women are excluded from this study because pregnancy precluded immediate breast reconstruction in our patient population.
- Patients who weigh less than 50 kg, as there can be dose related toxicities of the bupivacaine dosing used n this study.
- Patients with moderate-severe hepatic or renal impairment because of the increased risk of toxicity.
- Patients receiving bilateral mastectomy with immediate pre-pectoral implant based reconstruction
Data sourced from ClinicalTrials.gov (NCT03722927). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.