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临床试验/NCT02142829
NCT02142829已完成4 期

Pain Control in Bariatric Patients: A Prospective Trial Comparing the Effectiveness of EXPAREL(R) Versus the On-Q(R) Pain Ball

Pacira Pharmaceuticals, Inc1 个研究点 分布在 1 个国家目标入组 101 人开始时间: 2012年11月最近更新:
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
101
试验地点
1
主要终点
Numeric rating scale (NRS) pain intensity scores

研究概览

简要总结

This study was conducted to compare the effectiveness of two local pain control methods in bariatric patients by assessing the amount of postoperative pain and amount of postoperative pain medications needed. This information was used to determine which local anesthetic provided the best pain control.

详细描述

The investigators have previously utilized the On-Q® pain ball to obtain local control by continuous delivery of bupivacaine to pain fibers at the incision site. On-Q makes use of an implanted catheter and a continuous infusion pump that the patient carries with them typically for 48-72 hours after surgery. EXPAREL is a long-acting liposomal delivery vehicle that extends the life of bupivacaine in the surgical site for up to 72 hours. It can be injected in all trocar sites and offers another potential solution to patient pain control without the need for a catheter and the hardware needed to deliver the local anesthetic. Patient NRS (numerical rating scale) scores for postoperative pain and total medication consumed were used to assess the differences between the two treatment groups.

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

入排标准

年龄范围
18 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Age 18-80, male or female

排除标准

  • Pregnant women

研究组 & 干预措施

EXPAREL

Active Comparator

EXPAREL (bupivacaine liposome injectable suspension)

干预措施: EXPAREL (Drug)

On-Q Pain Ball

Active Comparator

Device for delivering bupivacaine.

干预措施: On-Q Pain Ball (Drug)

结局指标

主要结局

Numeric rating scale (NRS) pain intensity scores

时间窗: 4-6 hours postoperatively and in the mornings of postoperative Day 1 and Day 2

The NRS was from 0 = no pain and 10 = worst pain.

次要结局

  • Postoperative opioid consumption(1 week)

研究者

申办方类型
Industry
责任方
Sponsor

研究点 (1)

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