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NCT Number: NCT06574022

Post-mastectomy Recovery: Comparing Preoperative PECS-II Blocks With Intraoperative Pectoral Blocks

The purpose this research is to compare two different standards of care for pain management and two different standards of care for local numbing medicine for breast cancer patients who will have a total mastectomy.

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Key information

Conditions

Mastectomy; Lymphedema Breast Cancer Breast Diseases Breast Neoplasms Hemic and Lymphatic Diseases Lymphatic Diseases Lymphedema Neoplasms Neoplasms by Site Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

University of Cincinnati Medical Center

Cincinnati, Ohio, 45219, United States

Location status: Recruiting

Location contact

Alicia Heelan, MD

CONTACT

About this study

The purpose this research is to compare two different standards of care for pain management and two different standards of care for local numbing medicine for breast cancer patients who will have a total mastectomy.

Standard of care intervention is preoperative PECS-II blocks versus Intraoperative Pectoral Blocks.

The medication used are standard of care and include Bupivacaine and liposomal bupivacaine. Bupivacaine is FDA approved and indicated for the local or regional anesthesia or analgesia for surgery procedures and therapeutic procedures. Liposomal bupivacaine is FDA approved and indicated for adults to produce postsurgical local analgesia and as nerve block to produce postsurgical regional analgesia.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients who are 18 years of age or older
  • Patients undergoing mastectomy with or without axillary surgery, with or without reconstruction surgery at UCMC for breast cancer or high-risk of breast cancer. Patients with high-risk of breast cancer are those who have atypical/precancerous breast lesion(s), genetic mutation with increased risk of cancer (e.g., BRCA1, BRCA2 etc..) and/or a strong family history of breast cancer in the opinion of the investigator.

Exclusion criteria

  • Patients undergoing only a partial mastectomy or tissue-based reconstruction.
  • Non-English speaking.
  • Patients who are pregnant.
  • Patients with an allergy to local anesthetics
  • Except: patients with allergies only to topical anesthetics may be included.
  • Patients with a preoperative acute or chronic pain disorder with an opioid prescription that has been prescribed within 30 days of surgery. Patients who have not filled such a prescription or who state they have not taken the medications prescribed, may be eligible on a case-by-case basis per investigator judgement.
  • Patients with a history of opioid use disorder.
  • Inability to provide informed consent.
  • Patients who otherwise in the opinion of the Investigator are not good candidates for participation (e.g., deemed unreliable for follow-up).

Treatment and study plan

Bupivacain

Drug

Intraoperative direct visualization of the pectoralis nerves and injection using a 21-gauge needle of 30 cc of 0.5% bupivacaine after mastectomy completion and prior to reconstruction, if performed, or wound closure.

Exparel

Drug

Intraoperative direct visualization of the pectoralis nerves and injection using a 21-gauge needle of 20 cc of Exparel mixed with 10 cc of 0.5% bupivacaine after mastectomy completion and prior to reconstruction, if performed, or wound closure.

Intraoperative Pecs II block (IOB) & superior AT (EX or BP)

Procedure

Intraoperative direct visualization of the pectoralis nerves and injection using a 21-gauge needle with superior anesthetic as determined by stage I, after mastectomy completion and prior to reconstruction, if performed, or wound closure.

Preoperative Pecs II block (POB) & superior AT (EX or BP)

Procedure

Preoperative Pecs II block to be administered by 1 of 6 acute pain specialized anesthesiologists in same day surgery. Patient will be lightly sedated with midazolam, at the discretion of the anesthesiologist. The pecs II block will be performed under ultrasound guidance using a 21-gauge, 80 mm length needle to administer the superior anesthetic as determined in stage I.

Primary outcomes

  1. Postoperative pain as indicated by postoperative opioid use via total inpatient and outpatient opioid use (oral morphine milliequivalents)

    Time frame: 14 days post-operation

    Post-operative opioid usage as measured by total inpatient and outpatient opioid use (oral morphine milliequivalents) through 14 days post-op.

  2. Postoperative pain as indicated by postoperative opioid use discontinuation

    Time frame: 14 days post-operation

    Post-operative opioid usage as measured by time to opiate discontinuation through 14 days post-op.

Secondary outcomes

  1. Post-operative pain scores indicated by patient report Numeric Rating Scale

    Time frame: 21 days Post Operation

    Post-operative pain scores as measured by the Numeric Rating Scale pain scores. Maximum, minimum, and mean pain scores on a scale of 0-10 each day of hospitalization, starting day of surgery.

  2. Post-operative pain scores indicated by patient survey

    Time frame: 21 days Post Operation

    Post-operative pain scores as measured by patient survey. Patient survey completed on post-operative days 1 (while inpatient) and at their post-operative appointment (1-3 weeks post-op). The patient survey is based on the Clinically Aligned Pain Tool which is a newer tool that attempts to address some of the major limitations inherent with the much more basic numeric rating scale. A score of 1 is the minimum while a score of 10 is the maximum. The higher the score, the more pain the patient is reporting.

  3. Patient satisfaction indicated by patient report

    Time frame: 21 days Post Operation

    Patient satisfaction measured at the patient's first postoperative visit (1-3 weeks post-op) using a 10-point Likert scale. The 10 Point Likert Scale will have minimum value of 1 and maximum of 10 with 1 being least satisfied (worse outcome) and 10 being most satisfied (better outcome).

  4. Intraoperative procedure time measured as from time of incision to start of closing

    Time frame: Day 0: Surgery

    Total intraoperative procedure time will be measured as from time of incision to start of closing if no reconstruction is performed or to time of Panel 1 completion to be followed by the reconstruction procedure by Panel 2.

  5. Intraoperative opioid administration measured in Milliequivalents

    Time frame: Day 0: Surgery

    Intraoperative opioid administration in IV Morphine Milliequivalents.

  6. Operating room delays measured as anesthesia start time that is greater than 1 hour after the scheduled start time

    Time frame: Day 0: Surgery

    Number of operating room delays will be measured as anesthesia start time that is greater than 1 hour after the scheduled start time.

  7. Postoperative length of stay as measured by the number of nights spent in the hospital after surgery.

    Time frame: Day 0-7

    Postoperative length of stay as measured by the number of nights spent in the hospital after surgery.

Study contacts

Contact information is provided by the study sponsor or research team.

Alicia Heelan, MD

CONTACT

UCCC Clinical Trials Office

CONTACT

[email protected]

513-584-7698

Sponsors and collaborators

Lead sponsor

University of Cincinnati

Other

Registry information

Official study title

Post-mastectomy Recovery: A Randomized Clinical Trial Comparing Preoperative PECS-II Blocks With Intraoperative Pectoral Blocks

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Aug 27, 2024
Registry last updated
Nov 4, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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