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临床试验/NCT04781075
NCT04781075已完成4 期

TAP (Transverse Abdominis Plane) Block With Exparel (Liposomal Bupivicaine) vs. Bupivicaine Post-op Pain Management

Ochsner Health System1 个研究点 分布在 1 个国家目标入组 76 人开始时间: 2017年12月1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
入组人数
76
试验地点
1
主要终点
Pain Scale

研究概览

简要总结

Single Blind, Randomized Controlled study to see if TAP Block with Exparel provides better pain relief than TAP Block with bupivicaine. Differences in Pain Scale, Length of Stay, and Total Narcotic use in the hospital will be evaluated.

详细描述

Subjects recruited into the study will undergo surgery as scheduled. During the procedure they will receive a TAP Block with one of the pain medications. TAP Block in the experimental arm will be performed with 20 mL (266mg) of liposomal bupivacaine with 25 mL (5 mg/mL) of bupivacaine diluted in 55 mL of normal saline. The control arm will have a TAP Block performed with 30 mL (5mg/mL) of bupivacaine diluted in 70 mL of normal saline. These doses are consistent with prior studies of TAP Block with liposomal bupivacaine. Subjects will be monitored for pain as per standard of care and will be given pain medication as needed.

Subject Recruitment and Screening Patients will be recruited from the Ochsner Colorectal Surgery Clinic at the time of a preoperative visit.

Study Procedures

Screening & Baseline Visit After obtaining informed consent the subjects relevant medical and surgical history will be documented. Demographics and vitals will be documented. Current use of pain medication will be recorded. A physical exam will be performed.

Day of Surgery Routine vital signs will be obtained preoperatively. During the operation subject will receive a TAP Block containing their randomized local injection mixture as described above. Following surgery the subject will recover the PACU and pain medication will be provided on demand. Initial postoperative vital signs and pain scores will be obtained at this time.

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 75 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients age 18-75 years undergoing planned laparoscopic colon or rectal resection

排除标准

  • Patients younger than 18 or older than 75 years old
  • Pregnant women
  • Patients who have taken steroids or other immunomodulators within the last 6 months
  • Patients on home narcotics
  • Patients allergic to Exparel or bupivacaine

研究组 & 干预措施

TAP Block with Exparel

Experimental

TAP Block with 20 mL (266mg) of liposomal bupivacaine with 25 mL (5 mg/mL) of bupivacaine diluted in 55 mL of normal saline

干预措施: Pain Scale (Other)

TAP Block with Exparel

Experimental

TAP Block with 20 mL (266mg) of liposomal bupivacaine with 25 mL (5 mg/mL) of bupivacaine diluted in 55 mL of normal saline

干预措施: Exparel Injectable Product (Drug)

TAP Block with bupivicaine

Active Comparator

TAP Block with 30 mL (5mg/mL) of bupivacaine diluted in 70 mL of normal saline

干预措施: Pain Scale (Other)

TAP Block with bupivicaine

Active Comparator

TAP Block with 30 mL (5mg/mL) of bupivacaine diluted in 70 mL of normal saline

干预措施: Bupivacaine Injection (Drug)

结局指标

主要结局

Pain Scale

时间窗: daily through study completion (up to 30 days)

Daily Pain Scale using Wong-baker FACES Pain Rating Scale 0 (no pain) - 10 (worst pain imaginable)

次要结局

  • Length of stay(daily through study completion (up to 30 days))
  • Narcotic use(daily through study completion (up to 30 days))

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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