Post-mastectomy Recovery: Comparing Preoperative PECS-II Blocks With Intraoperative Pectoral Blocks
Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of Cincinnati
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
Patients undergoing only a partial mastectomy or tissue-based reconstruction.
Non-English speaking.
Patients who are pregnant.
Patients with an allergy to local anesthetics
Trial design
Design model
Sequential
Treatments tested in this trial
Bupivacain
DrugIntraoperative 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
DrugIntraoperative 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/SurgeryIntraoperative 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/SurgeryPreoperative 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 groups
100 Participants
are divided into 4 treatment groupsGroup A: 1) Intraoperative Pecs Blocks (IOB) & 30 cc of 0.5% bupivacaine (PB)Active comparator 0 interventions
Group B: 2) Intraoperative Pecs Blocks (IOB) & 20 cc of Exparel mixed w/10 cc of 0.5% bupivacaine (EX)Active comparator 0 interventions
Group C: 3) Intraoperative Pecs II block (IOB) & superior AT (EX or BP)Active comparator 1 intervention
Group D: 4) Preoperative Pecs II block (POB) & superior AT (EX or BP)Active comparator 0 interventions
Trial outcomes
Primary outcomes
1
Postoperative pain as indicated by postoperative opioid use via total inpatient and outpatient opioid use (oral morphine milliequivalents)
Post-operative opioid usage as measured by total inpatient and outpatient opioid use (oral morphine milliequivalents) through 14 days post-op.
Time frame
14 days post-operation2
Postoperative pain as indicated by postoperative opioid use discontinuation
Post-operative opioid usage as measured by time to opiate discontinuation through 14 days post-op.
Time frame
14 days post-operationSecondary outcomes
1
Post-operative pain scores indicated by patient report Numeric Rating Scale
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.
Time frame
21 days Post Operation2
Post-operative pain scores indicated by patient survey
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.
Time frame
21 days Post Operation3
Patient satisfaction indicated by patient report
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).
Time frame
21 days Post Operation4
Intraoperative procedure time measured as from time of incision to start of closing
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.
Time frame
Day 0: SurgerySponsors and contacts
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Source ClinicalTrials.gov