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

University of Cincinnati

Status and phase: Not yet enrolling; Phase 4

Conditions: Breast Cancer; Mastectomy; Lymphedema

Treatments: Drug: Exparel; Drug: Bupivacain; Procedure: Intraoperative Pecs II block (IOB) & superior AT (EX or BP); Procedure: Preoperative Pecs II block (POB) & superior AT (EX or BP)

Study type: Interventional

Funder types: Other

Identifiers

NCT06574022

UCCC-BRE-23-01

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 100 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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).

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Sequential Assignment

Masking: None (Open label)

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100 participants in 4 patient groups

1) Intraoperative Pecs Blocks (IOB) & 30 cc of 0.5% bupivacaine (PB)

Active Comparator group

Description:

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.

Treatment:

Drug: Bupivacain

2) Intraoperative Pecs Blocks (IOB) & 20 cc of Exparel mixed w/10 cc of 0.5% bupivacaine (EX)

Active Comparator group

Description:

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.

Treatment:

Drug: Exparel

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

Active Comparator group

Description:

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.

Treatment:

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

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

Active Comparator group

Description:

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.

Treatment:

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