跳至主要内容
临床试验/NCT05171179
NCT05171179已完成3 期

A Prospective, Randomized Controlled Trial Investigating Pecs Blocks Types I and II as a Method for Administering the Non-Opioid Anesthetic Exparel in Order to Mitigate Postoperative Narcotic Usage, Pain, Nausea, and Hospital Stay in Patients Undergoing Implant-Based Tissue Expander Breast Reconstruction Surgery

Northwestern University1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2021年10月22日最近更新:
适应症
干预措施

试验速览

阶段
3 期
状态
已完成
入组人数
60
试验地点
1
主要终点
Opioid consumption

研究概览

简要总结

This project intends to more thoroughly investigate the direct influence of Pecs blocks in the administration of Exparel, a non-opioid analgesic, in breast reconstruction surgery. The hypothesis is that this analgesic delivery method will significantly reduce negative outcomes such as post-operative pain, opioid use, and nausea while increasing positive outcomes such as post-operative physical activity.

详细描述

The research team will be investigating the use of a novel type of local drug administration as well as assessing whether a non-opioid based drug will result in more positive pain outcomes while reducing reliance on narcotics (opioid-based drugs) following surgery.

The drug administration tool, called the Pecs blocks types I and II, utilizes ultrasound to help guide anesthetic injection for local anesthesia. This has been an effective way to deliver local anesthetic during breast surgeries. Meanwhile, a non-opioid analgesic drug (similar to an anesthetic, meaning it is used during surgery to reduce pain) called Exparel has been shown to reduce post-operative use of narcotics, length of stay in hospitals, and pain compared to the current standards in breast reconstruction surgery. Exparel is approved by the FDA for use in surgical sites during breast reconstruction surgery. Exparel has shown to reduce pain and post-surgical nausea and vomiting in breast reconstruction patients. However, the combination of Exparel with Pecs blocks has not been examined in breast reconstruction surgery, and the research team suspects that breast reconstruction patients who are administered Exparel with Pecs blocks will experience less pain, increased mobility, and less nausea following surgery. Furthermore, the researchers believe that this non-opioid based drug could reduce the necessity to use narcotics following surgery. Narcotics are highly addictive and can lead to dependency following surgery.

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)

盲法说明

Patient will be randomized into one of the two trial arms. Randomization process will involve 60 envelopes, 30 of which will contain assignment to the study arm with Exparel blocks and 30 which will contain assignment to bupivacaine blocks. The PI's attending nurse will randomly distribute an envelope to the study team between V1 and V2. V2, the day of surgery, will be the only visit where the patient would potentially have contact with the treatments. The patient will not be aware of what treatment they receive until after their 2-week follow-up.

入排标准

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

入选标准

  • Subjects greater than 18 years of age.
  • Subject who are undergoing implant-based, tissue expander breast reconstruction surgery.

排除标准

  • Subjects undergoing flap breast reconstruction.
  • Subjects who are undergoing direct-to-implant surgery.
  • Subjects who have previously undergone radiation therapy.
  • Medical or psychiatric condition that may increase the risk associated with study participation, may complicate patient compliance, or may interfere with the interpretation of study results and, in the judgment of the Investigator, would make the subject inappropriate for entry into this study.
  • Subjects who are pregnant at the date of surgery.

研究组 & 干预措施

Blocks+Bupivacaine

Active Comparator

Use of Pecs block types I and II with bupivacaine as local anesthetic

干预措施: Breast Reconstruction (Mammaplasty) (Procedure)

Blocks+Bupivacaine

Active Comparator

Use of Pecs block types I and II with bupivacaine as local anesthetic

干预措施: Pecs blocks (Device)

Blocks+Bupivacaine

Active Comparator

Use of Pecs block types I and II with bupivacaine as local anesthetic

干预措施: Bupivacaine (Drug)

Blocks+Bupivacaine+Exparel

Experimental

Use of Pecs block types I and II with mixture of bupivacaine and Exparel* (*Must include bupivacaine at lower dose to decrease intra-operative variability in pain control due to delayed onset of Exparel)

干预措施: Breast Reconstruction (Mammaplasty) (Procedure)

Blocks+Bupivacaine+Exparel

Experimental

Use of Pecs block types I and II with mixture of bupivacaine and Exparel* (*Must include bupivacaine at lower dose to decrease intra-operative variability in pain control due to delayed onset of Exparel)

干预措施: Pecs blocks (Device)

Blocks+Bupivacaine+Exparel

Experimental

Use of Pecs block types I and II with mixture of bupivacaine and Exparel* (*Must include bupivacaine at lower dose to decrease intra-operative variability in pain control due to delayed onset of Exparel)

干预措施: Exparel (Drug)

Blocks+Bupivacaine+Exparel

Experimental

Use of Pecs block types I and II with mixture of bupivacaine and Exparel* (*Must include bupivacaine at lower dose to decrease intra-operative variability in pain control due to delayed onset of Exparel)

干预措施: Bupivacaine (Drug)

结局指标

主要结局

Opioid consumption

时间窗: 2 weeks post op

• Investigate amount of post-operative opioid consumption post operatively

次要结局

  • Nausea(2 weeks post op)
  • Mobility(2 weeks post op)
  • Pain Outcomes(2 weeks post op)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Robert Galiano

Associate Professor of Surgery

Northwestern University

研究点 (1)

Loading locations...

相似试验