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

Sponsor
Northwestern University (Other)
Overall Status
Recruiting
CT.gov ID
NCT05171179
Collaborator
Pacira Pharmaceuticals, Inc (Industry)
90
1
3
13.4
6.7

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
Phase 3

Detailed 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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
90 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
Group 1 (Control): Intravenous (IV) lidocaine infusion without Pecs block (standard of care per ERAS protocol) Group 2: Use of Pecs block types I and II with bupivacaine as local anesthetic Group 3: 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)Group 1 (Control): Intravenous (IV) lidocaine infusion without Pecs block (standard of care per ERAS protocol) Group 2: Use of Pecs block types I and II with bupivacaine as local anesthetic Group 3: 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)
Masking:
Single (Participant)
Masking Description:
Patient will be randomized into one of the three trial arms. Randomization process will involve 90 envelopes, 30 of which will contain assignment to the study arm with Exparel blocks, 30 which will contain assignment to bupivacaine blocks, and 30 which will contain assignment to lidocaine infusion (the control arm). 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.
Primary Purpose:
Treatment
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
Actual Study Start Date :
Oct 18, 2021
Anticipated Primary Completion Date :
Aug 1, 2022
Anticipated Study Completion Date :
Dec 1, 2022

Arms and Interventions

Arm Intervention/Treatment
Other: Intravenous lidocaine

Intravenous (IV) lidocaine infusion without Pecs block (standard of care per ERAS protocol)

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

Drug: Lidocaine
This is an anesthetic delivered during breast reconstruction surgery that will be given to participants in arm 1.

Active Comparator: Blocks+Bupivacaine

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

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

Device: Pecs blocks
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.
Other Names:
  • Pecs blocks I and II
  • Drug: Bupivacaine
    This is an anesthetic delivered during breast reconstruction surgery that will be given to participants in arms 2 and 3.

    Experimental: Blocks+Bupivacaine+Exparel

    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)

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

    Device: Pecs blocks
    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.
    Other Names:
  • Pecs blocks I and II
  • Drug: Exparel
    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.

    Drug: Bupivacaine
    This is an anesthetic delivered during breast reconstruction surgery that will be given to participants in arms 2 and 3.

    Outcome Measures

    Primary Outcome Measures

    1. Opioid consumption [2 weeks post op]

      • Investigate amount of post-operative opioid consumption post operatively

    Secondary Outcome Measures

    1. Nausea [2 weeks post op]

      • Assess Post-Operative Nausea scores among the three arms using the participant-recorded Edmonton Symptom Assessment tool which scores on a scale of one to ten, where ten is the most nausea experienced

    2. Mobility [2 weeks post op]

      • Assess post-operative mobility using the participant-recorded Edmonton Symptom Assessment tool which scores on a scale of one to ten where ten is the most immobile

    3. Pain Outcomes [2 weeks post op]

      • Assess the pain patients experience throughout their recovery period using the participant-recorded Edmonton Symptom Assessment tool which scores on a scale of one to ten where ten is the highest pain

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    Female
    Accepts Healthy Volunteers:
    Yes
    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Northwestern Memorial Hospital Chicago Illinois United States 60611

    Sponsors and Collaborators

    • Northwestern University
    • Pacira Pharmaceuticals, Inc

    Investigators

    • Principal Investigator: Robert Galiano, MD, 3126956022

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Robert Galiano, Associate Professor of Surgery, Northwestern University
    ClinicalTrials.gov Identifier:
    NCT05171179
    Other Study ID Numbers:
    • STU00214187
    First Posted:
    Dec 28, 2021
    Last Update Posted:
    Dec 28, 2021
    Last Verified:
    Dec 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    No
    Product Manufactured in and Exported from the U.S.:
    No
    Keywords provided by Robert Galiano, Associate Professor of Surgery, Northwestern University
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Dec 28, 2021