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

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

NCT ID: NCT06574022

Condition: Mastectomy; Lymphedema
Breast Cancer

Conditions: Official terms:
Lymphedema
Bupivacaine

Study type: Interventional

Study phase: Phase 4

Overall status: Not yet recruiting

Study design:

Allocation: Randomized

Intervention model: Sequential Assignment

Intervention model description: Stage I:randomized trial to establish effectiveness of AT with IOB. Stage II, evaluate two BTs based on stage I results. Enroll40 patients in each group for alpha=5% and power=80% (1 interim analysis after 50% enrollment). With n1=20 and n2=20, if we obtain p-value <0.025 for comparing number of pills used in two groups (we assume EX is better than PB), we conduct stage II. Otherwise, we continue enroll n1=40 and n2=40 and compare the mean pill counts between groups; if the observed p-value is less than 0.025, then EX superior. If the observed p-value is not significant, continue with EX. If we find EX is inferior to PB, perform a subset analysis and modify I/E criteria in stage II. In stage II, we test the efficacy of BT with superior AT. We enroll 60 patients. Randomize the ratio of 2:1 in favor of CPT. We use patients in stage I treated IOB with the superior AT in the analysis. We will have n1=40 or 60 and n2=40. At least 80% power to detect the same effect sizes.

Primary purpose: Supportive Care

Masking: None (Open Label)

Intervention:

Intervention type: Drug
Intervention name: Bupivacain
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.
Arm group label: 1) Intraoperative Pecs Blocks (IOB) & 30 cc of 0.5% bupivacaine (PB)

Intervention type: Drug
Intervention name: Exparel
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.
Arm group label: 2) Intraoperative Pecs Blocks (IOB) & 20 cc of Exparel mixed w/10 cc of 0.5% bupivacaine (EX)

Intervention type: Procedure
Intervention name: Intraoperative Pecs II block (IOB) & superior AT (EX or BP)
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.
Arm group label: 3) Intraoperative Pecs II block (IOB) & superior AT (EX or BP)

Intervention type: Procedure
Intervention name: Preoperative Pecs II block (POB) & superior AT (EX or BP)
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.
Arm group label: 4) Preoperative Pecs II block (POB) & superior AT (EX or BP)

Summary: 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.

Criteria for 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).

Gender: All

Minimum age: 18 Years

Maximum age: N/A

Healthy volunteers: No

Locations:

Facility:
Name: University of Cincinnati Medical Center

Address:
City: Cincinnati
Zip: 45219
Country: United States

Contact:
Last name: Alicia Heelan, MD

Start date: September 1, 2024

Completion date: December 1, 2026

Lead sponsor:
Agency: University of Cincinnati
Agency class: Other

Source: University of Cincinnati

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT06574022