COMPLETED

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

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

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

Quick Facts

Study Start:2021-10-22
Study Completion:2025-07-01
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:COMPLETED

Study ID

NCT05171179

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:FEMALE
Accepts Healthy Volunteers:Yes
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. 1. Subjects greater than 18 years of age.
  2. 2. Subject who are undergoing implant-based, tissue expander breast reconstruction surgery.
  1. 1. Subjects undergoing flap breast reconstruction.
  2. 2. Subjects who are undergoing direct-to-implant surgery.
  3. 3. Subjects who have previously undergone radiation therapy.
  4. 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. 5. Subjects who are pregnant at the date of surgery.

Contacts and Locations

Principal Investigator

Robert Galiano, MD
PRINCIPAL_INVESTIGATOR
3126956022

Study Locations (Sites)

Northwestern Memorial Hospital
Chicago, Illinois, 60611
United States

Collaborators and Investigators

Sponsor: Northwestern University

  • Robert Galiano, MD, PRINCIPAL_INVESTIGATOR, 3126956022

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2021-10-22
Study Completion Date2025-07-01

Study Record Updates

Study Start Date2021-10-22
Study Completion Date2025-07-01

Terms related to this study

Keywords Provided by Researchers

  • breast reconstruction
  • mammaplasty
  • analgesic

Additional Relevant MeSH Terms

  • Mammaplasty