Mastectomy; LymphedemaPhase 4NCT06574022
Post-mastectomy Recovery: Comparing Preoperative PECS-II Blocks With Intraoperative Pectoral Blocks
A Phase 4 study testing Bupivacain, Exparel and Intraoperative Pecs II block (IOB) & superior AT (EX or BP) in people with Mastectomy; Lymphedema and Breast Cancer, run by University of Cincinnati at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Mastectomy; Lymphedema, Breast Cancer
- What is being tested?
- Bupivacain, Exparel and Intraoperative Pecs II block (IOB) & superior AT (EX or BP)
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- 25 Sep 2024to 1 Dec 2026
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 9Show fewer
- 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).
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Alicia Heelan, MD contact
United States1 site, 1 recruiting
- Recruiting
University of Cincinnati Medical Center
Cincinnati, Ohio, 45219
Alicia Heelan, MD
About this study
Official title: Post-mastectomy Recovery: A Randomized Clinical Trial Comparing Preoperative PECS-II Blocks With Intraoperative Pectoral Blocks
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.
Read the 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.
- Conditions
- Mastectomy; Lymphedema, Breast Cancer
- Being tested
- Bupivacain, Exparel, Intraoperative Pecs II block (IOB) & superior AT (EX or BP), Preoperative Pecs II block (POB) & superior AT (EX or BP)
- Medical subject headings
- Lymphedema, Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BupivacainDrug
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.
ExparelDrug
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 or surgery
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 or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Procedure: Intraoperative Pecs II block (IOB) & superior AT (EX or BP) |
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 14 days post-operation
Secondary outcomes (7)
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.
Measured: 21 days Post Operation
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.
Measured: 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).
Measured: 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.
Measured: Day 0: Surgery
Intraoperative opioid administration measured in Milliequivalents
Intraoperative opioid administration in IV Morphine Milliequivalents.
Measured: 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.
Measured: 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.
Measured: Day 0-7
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Aug 2024
- Study start25 Sep 2024
- Primary completion1 Aug 2026 (estimated)
- Study completion1 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mastectomy; LymphedemaStudies of the same condition, open and under way.
- More trials run by University of CincinnatiThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Sequential
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Cincinnati
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Alicia Heelan, University of Cincinnati
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06574022
- Sponsor's protocol ID
- UCCC-BRE-23-01
- Status last verified
- Nov 2025
- First submitted
- 9 Aug 2024
- Last updated
- 4 Nov 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Post-mastectomy Recovery: A Randomized Clinical Trial Comparing Preoperative PECS-II Blocks With Intraoperative Pectoral Blocks
- ClinicalTrials.gov ID
- NCT06574022
- Acronym / sponsor ID
- UCCC-BRE-23-01
- Conditions
- Mastectomy; Lymphedema, Breast Cancer
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- University of CincinnatiUniversity, hospital or other
- Study start
- 25 Sep 2024 (actual)
- Primary completion
- 1 Aug 2026 (estimated)
- Study completion
- 1 Dec 2026 (estimated)
- First posted
- 27 Aug 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 4
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| 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 | 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. |
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (9 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BupivacainIntraoperative 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 | – |
| ExparelIntraoperative 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. | Drug | – |
| 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 or surgery | 3) Intraoperative Pecs II block (IOB) & superior AT (EX or BP) |
| 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. | Procedure or surgery | – |
Primary outcome
Postoperative pain as indicated by postoperative opioid use via total inpatient and outpatient opioid use (oral morphine milliequivalents)
Time frame: 14 days post-operation
Post-operative opioid usage as measured by total inpatient and outpatient opioid use (oral morphine milliequivalents) through 14 days post-op.
Postoperative pain as indicated by postoperative opioid use discontinuation
Time frame: 14 days post-operation
Post-operative opioid usage as measured by time to opiate discontinuation through 14 days post-op.
7 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Nov 2025.
- Individual participant dataSharing planned: No
Related trials for Mastectomy; Lymphedema
Enrolling by invitation
Comparison of the Effects of Kinesio Taping and Compression Bandaging on Edema, Range of Motion, Upper Extremity Function, and Grip Strength in Patients With Breast Cancer-Related Lymphedema
Lymphedema, Lymphedema Arm
Recruiting
Effect of Resisted Deep Breathing and Myofascial Release in Postmastectomy
Post Mastectomy Lymphedema
Enrolling by invitation
Ultrasound-Guided Percutaneous Cryoneurolysis to Treat Postoperative Pain After Mastectomy
Mastectomy; Lymphedema
RecruitingPhase 2
IIT2023-09-Chung-UpfrontTAD: Upfront TAD/SNB in Patients With Breast Cancer With Nodal Metastases
Breast Cancer, Axillary Nodal Disease
Recruiting
Pectoral Nerve Block Versus Paravertebral Block In The Incidence of Chronic Pain After Breast Cancer Surgery
Paravertebral Block, Pectoral Nerve Block
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Alicia Heelan, MD contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Bupivacain, Exparel and Intraoperative Pecs II block (IOB) & superior AT (EX or BP) in people with Mastectomy; Lymphedema and Breast Cancer, run by University of Cincinnati at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 4 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact UCCC Clinical Trials Office (513-584-7698, cancer@uchealth.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Postoperative pain as indicated by postoperative opioid use via total inpatient and outpatient opioid use (oral morphine milliequivalents) (time frame: 14 days post-operation). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Nov 2025.