Liposomal Bupivacaine in Implant Based Breast Reconstruction
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- The Effect of Liposomal Bupivacaine on Antiemetic Consumption
研究概览
简要总结
Objectives:
- To evaluate the effect of liposomal bupivacaine on postoperative pain levels.
- To evaluate the effect of liposomal bupivacaine on postoperative opioid consumption and opioid related adverse events.
- To evaluate the effect of liposomal bupivacaine on length of hospital stay.
- To evaluate the effect of liposomal bupivacaine on patient satisfaction with postoperative pain control.
- To evaluate the effect of liposomal bupivacaine on overall patient satisfaction.
详细描述
Objectives:
- To evaluate the effect of liposomal bupivacaine on postoperative pain levels.
- To evaluate the effect of liposomal bupivacaine on postoperative opioid consumption and opioid related adverse events.
- To evaluate the effect of liposomal bupivacaine on length of hospital stay.
- To evaluate the effect of liposomal bupivacaine on patient satisfaction with postoperative pain control.
- To evaluate the effect of liposomal bupivacaine on overall patient satisfaction.
The objective of this project is to evaluate the role of liposomal bupivacaine in postoperative pain control following tissue expander and implant based breast reconstruction. This unique formulation of bupivacaine lends this drug a longer duration of action and reduced plasma bupivacaine concentrations compared to plain bupivacaine. This agent has been demonstrated to be safe, well tolerated, and effective in a number of different clinical applications. However, its role has yet to be evaluated in the context of breast reconstruction.
Thus, the authors propose the first, randomized, controlled clinical trial of liposomal bupivacaine for postoperative pain management following tissue expander and implant based breast reconstruction. Patients will be stratified into two study groups. Patients in the Group 1 (Bupivacaine) will be treated intraoperatively with injections of 0.5% bupivacaine and epinephrine 1:200,000, with 50 mg delivered to perform a field block of each pocket. This is the current standard of care. Patients in the Group 2 (Liposomal Bupivacaine) will be treated intraoperatively with injections of 1.33% liposomal bupivacaine, with 133 mg delivered to perform a field block of each breast pocket. This is the experimental intervention. Postoperatively, the investigators will assess pain levels, opioid consumption, opioid related adverse events, length of stay, and satisfaction.
The findings from this study will allow the authors to better elucidate the role of liposomal bupivacaine in expander/implant based breast reconstruction. In doing so, they may allow the authors to identify the ideal pain regimen for these patients. This holds important implications, with the potential to reduce postoperative pain, opioid consumption, opioid related adverse events, length of stay, and patient satisfaction.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 99 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Women undergoing immediate unilateral or bilateral tissue-expander breast reconstruction following skin-sparing or nipple-sparing mastectomy
排除标准
- •Women who are unable to give informed consent to participate in this study
- •Women with a documented history of hypersensitivity reactions to local-anesthetic agents
- •Women with a diagnosis of chronic pain disorders such as fibromyalgia, chronic migraine headaches, or psychiatric disorders other than depression or anxiety
- •Women who are currently pregnant
- •Women undergoing tissue expander based breast reconstruction with a muscle flap in combination with a tissue expander
- •Women with impaired hepatic function
研究组 & 干预措施
Bupivacaine with epinephrine injections
Patients in the control arm of the study will be treated intra-operatively with standard of care, 0.5% bupivacaine and epinephrine injection (1:200,000), with 50 mg delivered into each breast pocket to perform a field block of the breast pocket (see below). Postoperatively, these patients will be treated with standard postoperative pain control, including narcotics as needed, such as morphine sulfate and hydrocodone/acetaminophen, and muscle relaxants, such as diazepam.
干预措施: Bupivacaine with epinephrine (Drug)
Bupivacaine with epinephrine injections
Patients in the control arm of the study will be treated intra-operatively with standard of care, 0.5% bupivacaine and epinephrine injection (1:200,000), with 50 mg delivered into each breast pocket to perform a field block of the breast pocket (see below). Postoperatively, these patients will be treated with standard postoperative pain control, including narcotics as needed, such as morphine sulfate and hydrocodone/acetaminophen, and muscle relaxants, such as diazepam.
干预措施: Morphine sulfate (Drug)
Bupivacaine with epinephrine injections
Patients in the control arm of the study will be treated intra-operatively with standard of care, 0.5% bupivacaine and epinephrine injection (1:200,000), with 50 mg delivered into each breast pocket to perform a field block of the breast pocket (see below). Postoperatively, these patients will be treated with standard postoperative pain control, including narcotics as needed, such as morphine sulfate and hydrocodone/acetaminophen, and muscle relaxants, such as diazepam.
干预措施: Hydrocodone/acetaminophen (Drug)
Bupivacaine with epinephrine injections
Patients in the control arm of the study will be treated intra-operatively with standard of care, 0.5% bupivacaine and epinephrine injection (1:200,000), with 50 mg delivered into each breast pocket to perform a field block of the breast pocket (see below). Postoperatively, these patients will be treated with standard postoperative pain control, including narcotics as needed, such as morphine sulfate and hydrocodone/acetaminophen, and muscle relaxants, such as diazepam.
干预措施: Diazepam (Drug)
Liposomal bupivacaine
Patients in the experimental arm of the study will be treated intra-operatively with 1.33% liposomal bupivacaine, with 133 mg delivered to perform a field block of each breast pocket. Postoperatively, these patients will be treated with standard postoperative pain control, including narcotics as needed, such as morphine sulfate and hydrocodone/acetaminophen, and muscle relaxants, such as diazepam.
干预措施: Liposomal bupivacaine (Drug)
Liposomal bupivacaine
Patients in the experimental arm of the study will be treated intra-operatively with 1.33% liposomal bupivacaine, with 133 mg delivered to perform a field block of each breast pocket. Postoperatively, these patients will be treated with standard postoperative pain control, including narcotics as needed, such as morphine sulfate and hydrocodone/acetaminophen, and muscle relaxants, such as diazepam.
干预措施: Morphine sulfate (Drug)
Liposomal bupivacaine
Patients in the experimental arm of the study will be treated intra-operatively with 1.33% liposomal bupivacaine, with 133 mg delivered to perform a field block of each breast pocket. Postoperatively, these patients will be treated with standard postoperative pain control, including narcotics as needed, such as morphine sulfate and hydrocodone/acetaminophen, and muscle relaxants, such as diazepam.
干预措施: Hydrocodone/acetaminophen (Drug)
Liposomal bupivacaine
Patients in the experimental arm of the study will be treated intra-operatively with 1.33% liposomal bupivacaine, with 133 mg delivered to perform a field block of each breast pocket. Postoperatively, these patients will be treated with standard postoperative pain control, including narcotics as needed, such as morphine sulfate and hydrocodone/acetaminophen, and muscle relaxants, such as diazepam.
干预措施: Diazepam (Drug)
结局指标
主要结局
The Effect of Liposomal Bupivacaine on Antiemetic Consumption
时间窗: 24 hours
The effect of liposomal bupivacaine on antiemetic consumption was assessed in mg of ondansetron consumed over first 24 hours post-operatively.
The Effect of Liposomal Bupivacaine on Postoperative Opioid Consumption
时间窗: 24 hours
Postoperative opioid consumption will be determined in each group. Opioid consumption post-operatively will be determined for patients in each group in standardized units of morphine milligram dosing equivalents per hour.
The Effect of Liposomal Bupivacaine on Length of Hospital Stay
时间窗: 24-60 hours
Length of hospital stay will be determined for patients in each group, in total hours.
The Effect of Liposomal Bupivacaine on Postoperative Diazepam Consumption
时间窗: 24 hours
Benzodiazepine consumption, in mg of diazepam, was recorded for all patients and compared over the first 24 hours post-operatively.
The Effect of Liposomal Bupivacaine on Average Postoperative Pain Levels on Postoperative Day 1.
时间窗: Average Pain Scores 24 hours Post-Operatively
Postoperative pain levels were determined with a numeric rating scale (NRS), rating pain from 0 - 10, where 0 = no pain, 10 = worst possible pain. Higher scores indicate a worse outcome. Pain levels were determined during routine vital signs every 4 hours post-operatively.
次要结局
未报告次要终点
研究者
Subhas Gupta, MD, PhD
Principal Investigator
Loma Linda University