The Use of Pecs Blocks in Combination With Exparel in Breast Reconstruction Surgery

Last updated: February 13, 2025
Sponsor: Northwestern University
Overall Status: Active - Recruiting

Phase

3

Condition

Breast Reconstruction

Treatment

Breast Reconstruction (Mammaplasty)

Lidocaine

Exparel

Clinical Study ID

NCT05171179
STU00214187
  • Ages > 18
  • Female
  • Accepts Healthy Volunteers

Study Summary

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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Subjects greater than 18 years of age.

  2. Subject who are undergoing implant-based, tissue expander breast reconstructionsurgery.

Exclusion

Exclusion Criteria:

  1. Subjects undergoing flap breast reconstruction.

  2. Subjects who are undergoing direct-to-implant surgery.

  3. Subjects who have previously undergone radiation therapy.

  4. Medical or psychiatric condition that may increase the risk associated with studyparticipation, may complicate patient compliance, or may interfere with theinterpretation of study results and, in the judgment of the Investigator, would makethe subject inappropriate for entry into this study.

  5. Subjects who are pregnant at the date of surgery.

Study Design

Total Participants: 90
Treatment Group(s): 5
Primary Treatment: Breast Reconstruction (Mammaplasty)
Phase: 3
Study Start date:
October 22, 2021
Estimated Completion Date:
September 30, 2025

Study Description

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 hope to show that this non-opioid based drug successfully reduces the necessity to use narcotics following surgery. Narcotics are highly addictive and can lead to dependency following surgery.

The reason the project has three different groups in this study is to show if each group has different outcomes. First, the project hopes to see a difference between the Pecs blocks and normal anesthesia delivery. Then, researchers hope to see a difference between the two Pecs blocks group where the use of Exparel will result in less narcotic use, pain, nausea, and increase mobility.

Connect with a study center

  • Northwestern Memorial Hospital

    Chicago, Illinois 60611
    United States

    Active - Recruiting

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