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

Mammaplasty Clinical Trial

Official title: 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

Status Recruiting

Clinical Trial 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.

Clinical Trial 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. ;

Related Conditions & MeSH terms

• Mammaplasty

• NCT number: NCT05171179
• Study type: Interventional
• Source: Northwestern University
• Contact: Robert Galiano, MD
• Phone: 3126956022
• Email: robert.galiano@nm.org
• Status: Recruiting
• Phase: Phase 3
• Start date: October 22, 2021
• Completion date: April 2024