Clinical trial NCT06574022: 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
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE4
Conditions: Mastectomy; Lymphedema
Breast Cancer
Lead sponsor: University of Cincinnati
Sponsor class: OTHER
First posted: 2024-08-27
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
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

Brief 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.

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).

Primary outcomes:
measure: Postoperative pain as indicated by postoperative opioid use via total inpatient and outpatient opioid use (oral morphine milliequivalents)
timeFrame: 14 days post-operation
measure: Postoperative pain as indicated by postoperative opioid use discontinuation
timeFrame: 14 days post-operation
Secondary outcomes:
measure: Post-operative pain scores indicated by patient report Numeric Rating Scale
timeFrame: 21 days Post Operation
measure: Post-operative pain scores indicated by patient survey
timeFrame: 21 days Post Operation
measure: Patient satisfaction indicated by patient report
timeFrame: 21 days Post Operation
measure: Intraoperative procedure time measured as from time of incision to start of closing
timeFrame: Day 0: Surgery
measure: Intraoperative opioid administration measured in Milliequivalents
timeFrame: Day 0: Surgery
measure: Operating room delays measured as anesthesia start time that is greater than 1 hour after the scheduled start time
timeFrame: Day 0: Surgery
measure: Postoperative length of stay as measured by the number of nights spent in the hospital after surgery.
timeFrame: Day 0-7
Other outcomes:
Locations:
city: Cincinnati
country: United States
facility: University of Cincinnati Medical Center
state: Ohio
Study officials:
References: