The Use of Liposomal Bupivacaine for Pain Control Following Mastectomy and Breast Reconstruction
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 3
- 试验地点
- 1
- 主要终点
- Mean Visual Analog Scores
研究概览
简要总结
The purpose of this research study is to determine how well the local anesthetic, liposomal bupivacaine, controls postoperative pain after mastectomy and breast reconstruction.
详细描述
Eligible subjects will be identified prior to surgery. On the day of surgery, each patient will be randomized to be in either Local infiltration of bupivacaine OR liposomal bupivacaine. Study will be double blinded to patients and Investigators. Patients assigned to the local infiltration with bupivacaine group will receive a total 60 ml of 0.25% bupivacaine with 30 ml delivered to each breast. Patients assigned to the local infiltration of liposomal bupivacaine will receive a total of 20 ml liposomal bupivacaine (266 mg) with 10 ml of 0.25% bupivacaine and 30 ml of 0.9% sodium chloride. These injections will occur at the end of the mastectomy and prior to the insertion of the tissue expander implant. After this intraoperative injection, patients will not receive any more doses of local anesthetics.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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
研究组 & 干预措施
Bupivacaine Group
Participants will be randomized to the Bupivacaine Group and receive a bilateral mastectomy with immediate implant based breast reconstruction
干预措施: Bupivacaine (Drug)
Liposomal Bupivacaine Group
Participants will be randomized to the Liposomal Bupivacaine Group and receive a bilateral mastectomy with immediate implant based breast reconstruction
干预措施: Liposomal Bupivacaine (Drug)
结局指标
主要结局
Mean Visual Analog Scores
时间窗: 48 hours
This will be measured every 12 hours for the first 48 hours postoperatively by the level of breast pain associated with arm movements while eating on a scale of 0-10 with higher scores denoting worse outcomes.
次要结局
- Area Under the Curve Visual Analog Scores (Submuscular Augmentation Mammoplasty)(48 hours)
- Length of Stay for Hospitalization(up to 47 Hours)
- Number of Morphine Doses Across All Subjects(1 Month)
- Readmission Rates to the Hospital(Month 2)
- Frequency of Postoperative Opioid Related Adverse Effects(Postoperatively, 1 week)
- Pain Intensity With Movement(Up to 2 months)