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临床试验/NCT03878888
NCT03878888已完成4 期

The Use of Exparel (Liposomal Bupivacaine) for Bilateral TAP (Transversus Abdominis Plane) Blocks in Open Abdomen Surgery for Postoperative Pain Control

St. Luke's Hospital, Pennsylvania1 个研究点 分布在 1 个国家目标入组 52 人开始时间: 2019年1月15日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
4 期
状态
已完成
发起方
入组人数
52
试验地点
1
主要终点
Reduce opioid requirement use (calculated oral morphine equivalents (OME)) for 2-3 days time after surgery.

研究概览

简要总结

To determine if Exparel (Liposomal Bupivacaine, an FDA approved drug) use in ultrasound guided Transversus Abdominis Plane (TAP) blocks may reduce opioid requirement use postoperatively, reduce pain scores postoperatively, reduce incidence of nausea in the postop period, and decrease length of hospital stay

详细描述

Exparel is liposomal form of bupivacaine, a local anesthetic. Secondary to its liposomal nature, Exparel slowly releases bupivacaine into the area injected (ultrasound guided field block) so that it may provide relief from pain for up to 48-72 hours time.

Exparel in TAP blocks may be performed on patients undergoing open or laparoscopic hand assisted abdomen/pelvic procedures, who are NOT candidates for an epidural (anticoagulation medication use, history of spine surgery with metal hardware of the mid-lower back) or as a rescue block for patients who undergo laparoscopic surgery but converted to open abdominal surgery in the operating room.

This block is usually performed intraoperatively (before patient wakes up from anesthesia) or in the immediate postop recovery unit (PACU) area.

Anesthesia personnel who have been well trained to perform ultrasound guided bilateral TAP blocks will combine Exparel 20 cc's with 0.25% Bupivicaine 20 ccs and 20 ccs of normal saline into a 60 cc syringe. With ultrasound machine, they will locate the TAP block on each side of abdomen with a Stimuplex needle. Once the TAP area is found, hydrodissection with normal saline is used to confirm TAP area, and then 30 ccs of the Exparel/0.25% Bupivacaine/normal saline solution administered to each side.

Patients are seen in the PACU area, where pain scores and oral morphine equivalents (OME) are calculated. Patient seen in postoperative day (POD) 1 to discuss expectations of pain control and goals for pain management (i.e. use of multimodal pain regimen and goals to decrease opioid use). A flyer (approved by the Patient Education Committee) is provided to patient on POD 1 for further patient education. Pain scores and OMEs calculated for POD 0-5. Progress notes in patient's chart and patient interview also discloses if patient had episodes of N/V, another data point we will collect. We will finally review patient charts for length of admission (date of admission to date of discharge) Our control group: patients that had open abdominal or hand assisted laparoscopic surgery and who did not receive a TAP block, and received mainly opioids for postop pain control. For the comparison (control) group, we will calculate OME requirements while in PACU, and from POD 1-POD 5. We will see patients during POD 1 to discuss expectations of pain control and goals for pain management. Progress notes in patient's chart and patient interview also discloses if patient had episodes of N/V, another data point we will collect. We will finally review patient's chart for length of admission (date of admission to date of discharge) We are looking for an N=20 for the Exparel TAP block (experimental) group and N=20 for no TAP block (control) group

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

盲法说明

no masking; will provide qualified patients the opportunity to receive Exparel (liposomal bupivacaine) in Bilateral TAP blocks for open abdomen surgery

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

  • Women of Reproductive Potential
  • Men of Reproductive Potential
  • Minorities
  • Healthy Controls/Volunteers
  • Employees/Students
  • Vulnerable populations (trauma victims, students > 18 yrs age, aged infirm, substance abusers, impoverished, terminally ill,)
  • patients of above inclusion criteria who 1) are not candidates of an neuraxial blockade (i.e. epidural) for postoperative pain control 2) who underwent a laparoscopic to open procedure intraoperatively

排除标准

  • advanced dementia, not oriented to time or place
  • advanced liver disease
  • pregnant patients
  • allergy to amide local anesthesia
  • allergy to methemoglobinemia

研究组 & 干预措施

Exparel use in TAP block

Experimental

Exparel used in bilateral TAP block for open abdomen surgery

干预措施: Exparel 266 MG Per 20 ML Injection (Drug)

结局指标

主要结局

Reduce opioid requirement use (calculated oral morphine equivalents (OME)) for 2-3 days time after surgery.

时间窗: up until postoperative day 5

will review opioid/narcotic use in patient's chart

Reduce pain scores after surgery

时间窗: up until postoperative day 5

Numerical Rating Scale: 0-10; 0 being no pain, 10 being worst pain imaginable possible

次要结局

  • Reduce incidence of nausea postoperatively(up until Postoperative day 5)
  • Decrease length of hospital stay(up until postoperative day 5)

研究者

发起方
St. Luke's Hospital, Pennsylvania
申办方类型
Other
责任方
Sponsor

研究点 (1)

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