跳至主要内容
临床试验/NCT04254692
NCT04254692终止4 期

Randomized Controlled Trial Evaluating Liposomal Bupivacaine Following Abdominoplasty

University of Wisconsin, Madison2 个研究点 分布在 1 个国家目标入组 2 人开始时间: 2021年1月5日最近更新:
适应症
干预措施

试验速览

阶段
4 期
状态
终止
入组人数
2
试验地点
2
主要终点
Opioid Use at 24 Hours

研究概览

简要总结

The overall purpose of this study is to evaluate the analgesic efficacy of liposomal bupivacaine in optimizing pain control, minimizing the risk of postoperative nausea and vomiting (PONV), and improving recovery after abdominoplasty. This will be done by comparing intraoperative abdominal wall and incisional injection of bupivacaine to bupivacaine plus liposomal bupivacaine in 46 participants 18 years and older undergoing elective abdominoplasty. This will be studied using pain assessments, validated surveys, medication logs and review of medical records.

详细描述

Postoperative pain, nausea, and vomiting can be frustrating sequelae of elective surgery. Poorly managed postoperative pain can lead to increased opioid use, increased postoperative nausea and vomiting (PONV), delayed return to work and usual activities, unplanned hospital admissions, surgical complications, and patient dissatisfaction. In light of the growing opioid epidemic in the United States, any intervention that potentially minimizes opioid use may have meaningful individual and societal impact. Despite the use of multiple techniques for managing postoperative pain in abdominoplasty patients, pain control continues to be a challenge for this patient population.

One technique commonly employed to improve pain control is the use of abdominal wall and incisional injection of local anesthetic agents to block the sensory nerves supplying the anterior abdominal wall and abdominal incisions in order to decrease sensation and pain in the abdomen in the setting of abdominoplasty surgery. Local anesthetic often used in this procedure is bupivacaine (Marcaine) ± epinephrine. However, in 2012, a liposomal bupivacaine suspension (Exparel; Pacira BioSciences, Inc, San Diego, California) was introduced as a longer-acting local anesthetic used for management of postoperative pain. At the University of Wisconsin, patients undergoing abdominoplasty routinely receive intraoperative injection of local anesthetic to the abdominal wall and abdominal incisions, using bupivacaine as the local anesthetic, along with standard multimodal perioperative pain management including cool compresses, non-steroidal anti-inflammatories (NSAIDs), acetaminophen, and opioids.

The overall purpose of this study is to evaluate the analgesic efficacy of liposomal bupivacaine in optimizing pain control, minimizing the risk of PONV, and improving recovery after abdominoplasty. This will be done by comparing intraoperative abdominal wall and incisional injection of bupivacaine to bupivacaine plus liposomal bupivacaine in patients undergoing abdominoplasty. This will be studied using pain assessments, validated surveys, medication logs and review of medical records.

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
Double (Participant, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Medically cleared to undergo elective surgery (including associated anesthesia) at UW Madison Surgery Center (MSC).

排除标准

  • Pregnant or breast-feeding women
  • Incarcerated women or men
  • Individuals unable to give consent due to another condition such as impaired decision-making capacity.
  • Men or women who take opioid pain medications on a regular basis prior to surgery
  • Men or women with a history of opioid abuse and/or dependence
  • Participants with a history of bleeding disorders precluding safe abdominoplasty
  • Participants on anticoagulation therapy who have not held their anticoagulation as recommended by their surgeon or anesthesiologist
  • Participants not medically cleared for surgery at Madison Surgery Center. This would include participants with sepsis/bacteremia, significant valvular disorders or heart conditions.

研究组 & 干预措施

Liposomal Bupivacaine

Active Comparator

Participants in this study arm will receive intraoperative injection of Liposomal Bupivacaine mixed with Bupivacaine to the abdominal wall.

干预措施: Liposomal bupivacaine (Drug)

Bupivacaine

Other

Participants in this study arm will receive intraoperative injection of bupivacaine without Liposomal bupivacaine to the abdominal wall.

干预措施: Standard of care (Other)

结局指标

主要结局

Opioid Use at 24 Hours

时间窗: 24 hours postoperatively

Amount of opioids used postoperatively, measured in morphine equivalents

次要结局

  • Number of Participants With Postoperative Complications(1 week postoperatively)
  • Pain Score 1 Week Postop(1 week postoperatively)
  • Antiemetic Use 1 Week(1 week postoperatively)
  • Quality of Recovery-40 (QOR-40) Score(24 hours postoperatively)
  • Pain Score Postoperative Day 1 (POD 1)(24 hours postoperatively)
  • Antiemetic Use POD 1(24 hours postoperatively)
  • Opioid Use at 1 Week(1 week postoperatively)
  • Number of Participants With Postoperative Nausea and Vomiting(24 hours postoperatively)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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