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

Official title

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

Overview

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.

Detailed 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.

Interventions

• Drug Bupivacain
  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.
• Drug Exparel
  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.
• Procedure Intraoperative Pecs II block (IOB) & superior AT (EX or BP)
  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.
• Procedure Preoperative Pecs II block (POB) & superior AT (EX or BP)
  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 outcome measures

• Postoperative pain as indicated by postoperative opioid use via total inpatient and outpatient opioid use (oral morphine milliequivalents) [Time frame: 14 days post-operation]
• Postoperative pain as indicated by postoperative opioid use discontinuation [Time frame: 14 days post-operation]

Secondary outcome measures (7)

• Post-operative pain scores indicated by patient report Numeric Rating Scale [Time frame: 21 days Post Operation]
• Post-operative pain scores indicated by patient survey [Time frame: 21 days Post Operation]
• Patient satisfaction indicated by patient report [Time frame: 21 days Post Operation]
• Intraoperative procedure time measured as from time of incision to start of closing [Time frame: Day 0: Surgery]
• Intraoperative opioid administration measured in Milliequivalents [Time frame: Day 0: Surgery]
• Operating room delays measured as anesthesia start time that is greater than 1 hour after the scheduled start time [Time frame: Day 0: Surgery]
• Postoperative length of stay as measured by the number of nights spent in the hospital after surgery. [Time frame: Day 0-7]

Eligibility criteria

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).

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Sequential

Masking

Open label

Primary purpose

Supportive care

Study locations

United States · 1 center

• University of Cincinnati Medical Center — Cincinnati

Identifiers

NCT: NCT06574022 · UCCC-BRE-23-01

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗