Using Pecs blocks with Exparel for pain management in breast reconstruction
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
This study is testing if using a combination of a special pain block and a non-opioid pain medicine can help women feel less pain and recover better after breast reconstruction surgery.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Enrollment | 90 (estimated) |
| Ages | 18 Years and up |
| Sex | Female |
| Sponsor | Northwestern University Academic / other |
| Drugs / interventions | radiation |
| Locations | 1 site (Chicago, Illinois) |
| Trial ID | NCT05171179 on ClinicalTrials.gov |
What this trial studies
This project investigates the effectiveness of combining Pecs blocks, a local anesthesia technique, with Exparel, a non-opioid analgesic, during breast reconstruction surgery. The study aims to determine if this combination can reduce post-operative pain, opioid use, and nausea while enhancing physical activity after surgery. By utilizing ultrasound-guided Pecs blocks for anesthetic delivery, the research team hopes to demonstrate improved outcomes compared to traditional pain management methods. The trial will focus on patients undergoing implant-based breast reconstruction to assess the benefits of this innovative approach.
Who should consider this trial
Good fit: Ideal candidates are adults over 18 years old who are scheduled for implant-based breast reconstruction surgery.
Not a fit: Patients undergoing flap breast reconstruction or direct-to-implant surgery may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could lead to significantly reduced post-operative pain and lower reliance on narcotics for breast reconstruction patients.
How similar studies have performed: While the use of Pecs blocks and Exparel has shown promise individually, this specific combination in breast reconstruction has not been previously tested.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Chicago, Illinois
- Northwestern Memorial Hospital — Chicago, Illinois, United States (Recruiting)
Study contacts
- Principal investigator: Robert Galiano, MD — 3126956022
- Study coordinator: Robert Galiano, MD
- Email: robert.galiano@nm.org
- Phone: 3126956022
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.