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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1) Intraoperative Pecs Blocks (IOB) & 30 cc of 0.5% bupivacaine (PB) | Active Comparator | 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. | |
| 2) Intraoperative Pecs Blocks (IOB) & 20 cc of Exparel mixed w/10 cc of 0.5% bupivacaine (EX) | Active Comparator | 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. | |
| 3) Intraoperative Pecs II block (IOB) & superior AT (EX or BP) | Active Comparator | 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. |
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| 4) Preoperative Pecs II block (POB) & superior AT (EX or BP) | Active Comparator | 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Bupivacain | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 14 days post-operation |
| 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. | 14 days post-operation |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 21 days Post Operation |
| Post-operative pain scores indicated by patient survey |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| UCCC Clinical Trials Office | Contact | 513-584-7698 | cancer@uchealth.com | |
| Alicia Heelan, MD | Contact |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Cincinnati Medical Center | Recruiting | Cincinnati | Ohio | 45219 | United States |
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Study Design Summary:
Stage I: A randomized trial to assess the effectiveness of AT combined with IOB.
Stage II: Based on Stage I results, evaluate two BTs. Enroll 40 patients per group (n1 = 40, n2 = 40) to achieve 80% power at α = 0.05, with one interim analysis after 50% enrollment.
If interim results (n1 = 20, n2 = 20) show a p-value < 0.025 when comparing pill counts (hypothesizing EX is superior to PB), proceed to Stage II. If not, continue enrollment to full sample size and reanalyze.
If final p-value < 0.025, EX is considered superior. If not significant, continue with EX. If EX is inferior to PB, conduct subset analysis and revise inclusion/exclusion criteria for Stage II.
In Stage II, test BT efficacy using the superior AT. Enroll 60 patients, randomized 2:1 favoring CPT. Include Stage I patients treated with IOB and superior AT in analysis. Final sample sizes: n1 = 40 or 60, n2 = 40, maintaining ≥80% power.
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| Exparel | Drug | 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. |
| Intraoperative Pecs II block (IOB) & superior AT (EX or BP) | Procedure | 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. |
|
| Preoperative Pecs II block (POB) & superior AT (EX or BP) | Procedure | 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. |
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. |
| 21 days Post Operation |
| 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). | 21 days Post Operation |
| 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. | Day 0: Surgery |
| Intraoperative opioid administration measured in Milliequivalents | Intraoperative opioid administration in IV Morphine Milliequivalents. | Day 0: Surgery |
| Operating room delays measured as anesthesia start time that is greater than 1 hour after the scheduled start time | Number of operating room delays will be measured as anesthesia start time that is greater than 1 hour after the scheduled start time. | Day 0: Surgery |
| Postoperative length of stay as measured by the number of nights spent in the hospital after surgery. | Postoperative length of stay as measured by the number of nights spent in the hospital after surgery. | Day 0-7 |
| ID | Term |
|---|---|
| D008209 | Lymphedema |
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D008206 | Lymphatic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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| ID | Term |
|---|---|
| D002045 | Bupivacaine |
| D057725 | Operative Blood Salvage |
| D010643 | Phenoxybenzamine |
| ID | Term |
|---|---|
| D000813 | Anilides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000814 | Aniline Compounds |
| D000588 | Amines |
| D020858 | Tissue and Organ Harvesting |
| D014180 | Transplantation |
| D013514 | Surgical Procedures, Operative |
| D005021 | Ethylamines |
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