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

NCT05171179 | Completed Phase 3 FDA Drug

• 1 other identifier: STU00214187
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Mammaplasty

Keywords

breast reconstruction; mammaplasty; analgesic

Outcome Measures

Primary Outcomes (1)

• Opioid consumption

  • Investigate amount of post-operative opioid consumption post operatively

  2 weeks post op

Secondary Outcomes (3)

• Nausea

  2 weeks post op

• Mobility

  2 weeks post op

• Pain Outcomes

  2 weeks post op

Study Arms (2)

Blocks+Bupivacaine

ACTIVE COMPARATOR

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

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

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)

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

Interventions

Breast Reconstruction (Mammaplasty) PROCEDURE

Breast Reconstruction (mammaplasty) surgery with implant-based tissue expander

Blocks+Bupivacaine; Blocks+Bupivacaine+Exparel

Pecs blocks DEVICE

Pectoral nerve (Pecs) blocks I and II function by blocking the pectoral, intercostal, intercostobrachial nerves, and/or long thoracic nerve. These are used primarily for breast surgeries and are gaining momentum as simple administers of local analgesics. Pecs blocks utilize ultrasound to guide injection of local analgesic. It is less invasive and more accurate than most current modes of analgesia administration.

Also known as: Pecs blocks I and II

Blocks+Bupivacaine; Blocks+Bupivacaine+Exparel

Exparel DRUG

Exparel is a sterile, non-pyrogenic white to off-white preservative-free aqueous suspension of multivesicular liposomes (DepoFoam® drug delivery system) containing bupivacaine. Bupivacaine is present at a concentration of 13.3 mg/mL. After injection of Exparel, bupivacaine is released from the multivesicular liposomes over a period of time.

Blocks+Bupivacaine+Exparel

Bupivacaine DRUG

This is an anesthetic delivered during breast reconstruction surgery that will be given to participants in both arms.

Blocks+Bupivacaine; Blocks+Bupivacaine+Exparel

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Northwestern University: lead
• Pacira Pharmaceuticals, Inc: collaborator

Study Sites (1)

Northwestern Memorial Hospital

Chicago, Illinois, 60611, United States

Location

MeSH Terms

Interventions

Mammaplasty; Bupivacaine

Intervention Hierarchy (Ancestors)

Cosmetic Techniques; Therapeutics; Plastic Surgery Procedures; Surgical Procedures, Operative; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Study Officials

• Robert Galiano, MD

  3126956022

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Surgery

Model Details: 1. Group 1: Use of Pecs block types I and II with bupivacaine as local anesthetic 2. Group 2: 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 and in ability to use lidocaine infusion with injection of Exparel)

Study Record Dates

• First Submitted: November 4, 2021
• First Posted: December 28, 2021
• Study Start: October 22, 2021
• Primary Completion: May 1, 2025
• Study Completion: July 1, 2025
• Last Updated: September 24, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)