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

Northwestern University

Status and phase: Completed; Phase 3

Conditions: Mammaplasty

Treatments: Procedure: Breast Reconstruction (Mammaplasty); Device: Pecs blocks; Drug: Exparel; Drug: Bupivacaine

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT05171179

STU00214187

Details and patient eligibility

About

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.

Full 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 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.

Enrollment: 60 patients

Sex: Female

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

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

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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60 participants in 2 patient groups

Blocks+Bupivacaine

Active Comparator group

Description:

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

Treatment:

Drug: Bupivacaine

Device: Pecs blocks

Procedure: Breast Reconstruction (Mammaplasty)

Blocks+Bupivacaine+Exparel

Experimental group

Description:

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)

Treatment:

Drug: Bupivacaine

Drug: Exparel

Device: Pecs blocks

Procedure: Breast Reconstruction (Mammaplasty)