Post Operative PainNCT05795413
Quality of Recovery From Mastectomy With and Without PECS Blocks
An observational study of Post Operative Pain and Quality of Recovery After Mastectomy, run by Endeavor Health at 1 site in United States.
Trial summary
This is a prospective observational study. Investigators want to understand post-operative recovery for patients undergoing mastectomy at NorthShore University HealthSystem. Some of these patients receive PECS blocks with Liposomal Bupivacaine and some do not receive a block. Read more about this study
- Who is it for?
- Ages 18 to 90 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Post Operative Pain, Quality of Recovery After Mastectomy
- What is being tested?
- Mastectomy with PECS blocks and Liposomal bupivacaine
- Type of treatment
- Pill or oral medicine, Injection or infusion, Surgery or procedure
- How many people
- 800 participants
- Where
- 1 siteUnited States
- Study dates
- 25 Apr 2023to Apr 2027
- Phase
- Observational
- 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 to 90 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Study population: Females having mastectomy either for cancer diagnosis or prophylactic.
Who may be able to join
- Must be female Must be >18 years old and < 90 years old Must be able to consent in English or Spanish May or may not have breast cancer (prophylactic mastectomy) Must be undergoing unilateral or bilateral mastectomy of any type May choose to proceed with or without breast reconstruction
Who cannot join
- Allergy to all narcotic or local anesthetic medications Intake of any chronic opioids or pain medications preoperatively for a chronic condition or chronic use.
- Subjects who received PECS blocks but whose block failed or is deemed not effective by an anesthesia provider as indicated by postoperative evaluation exam.
- Vulnerable subjects (children, prisoners, pregnant women)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Patient Quality of Recovery From Mastectomy With and Without PECS Block With Liposomal Bupivacaine
This is a prospective observational study. Investigators want to understand post-operative recovery for patients undergoing mastectomy at NorthShore University HealthSystem. Some of these patients receive PECS blocks with Liposomal Bupivacaine and some do not receive a block. Investigators want to know whether patients who receive a block have better post operative recovery and pain control than patients who do not receive one. Investigators also want to understand whether PECS blocks with Liposomal Bupivacaine improves quality of recovery at 72 hours post operatively.
Read the detailed description
Investigators plan to approach and consent 800 patients undergoing mastectomy, 400 with PECS blocks and 400 without. Investigators will assess their quality of recovery using the QoR 15 survey at 72 hours post operatively. In addition, investigators will also record VAS scores immediately postoperatively and at 24, 48, and 72 hours postoperatively. The study team will also calculate the total morphine equivalents (MMEs) required for each patient after 72 hours.
- Being tested
- Mastectomy with PECS blocks, Liposomal bupivacaine
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mastectomy with PECS blocksProcedure or surgery
Approximately half of patients recruited will receive a PECS block with Liposomal bupivacaine and half will not receive a block.
Liposomal bupivacaineDrug
All of the PECS blocks performed at this institution have liposomal lupivacaine as the anesthetic. Investigators will examine quality of recovery and pain control in patients who receive a PECS block versus those who do not receive one.
| Study group | Role | What they receive |
|---|---|---|
| PECS Block with Liposomal Bupivacaine | The patients in this cohort will undergo a PECS block with Liposomal Bupivacaine before their mastectomy. Patients will receive Liposomal Bupivacaine in combination with 0.25% Bupivacaine in a 1:1 mixture for the purpose of post-operative pain control. Receives: Procedure: Mastectomy with PECS blocks; Drug: Liposomal bupivacaine | |
| No PECS block | The patients in cohort will not undergo a PECS block. Pain will be controlled in the usual fashion with IV and oral medications. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Quality of Recovery 15 Survey
Patients will complete the quality of recovery 15 survey 72 hours after surgery. This is a scale from 0 to 150. A score of 150 indicates better post operative recovery.
Measured: 72 hours post operatively
Secondary outcomes (8)
Visual analog scale
This is a pain scale from zero to ten. A score of 10 indicates worse pain.
Measured: Immediately post operatively
Visual analog scale
This is a pain scale from zero to ten. A score of 10 indicates worse pain.
Measured: 24 hours post operatively
Visual analog scale
This is a pain scale from zero to ten. A score of 10 indicates worse pain.
Measured: 48 hours post operatively
Visual analog scale
This is a pain scale from zero to ten. A score of 10 indicates worse pain.
Measured: 72 hours post operatively
Morphine milligram equivalents
We will record the amount of pain medication each patient takes after surgery. A higher morphine milligram equivalent indicates a higher amount of opioid medication used.
Measured: Immediately post operatively
Morphine milligram equivalents
We will record the amount of pain medication each patient takes after surgery. A higher morphine milligram equivalent indicates a higher amount of opioid medication used.
Measured: 24 hours post operatively
Morphine milligram equivalents
We will record the amount of pain medication each patient takes after surgery. A higher morphine milligram equivalent indicates a higher amount of opioid medication used.
Measured: 48 hours post operatively
Morphine milligram equivalents
We will record the amount of pain medication each patient takes after surgery. A higher morphine milligram equivalent indicates a higher amount of opioid medication used.
Measured: 72 hours post operatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Apr 2023
- Study start25 Apr 2023
- Primary completionApr 2026 (estimated)
- Study completionApr 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Post Operative PainStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 800 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Endeavor Health
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Katharine Yao, MD, Endeavor Health
- Investigators
- Katharine Yao, M.D., Principal investigator, Endeavor Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05795413
- Sponsor's protocol ID
- EH22-492
- Status last verified
- Oct 2025
- First submitted
- 8 Mar 2023
- Last updated
- 23 Oct 2025
- Results posted
- No
- Data monitoring committee
- No
- 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 23 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Patient Quality of Recovery From Mastectomy With and Without PECS Block With Liposomal Bupivacaine
- ClinicalTrials.gov ID
- NCT05795413
- Acronym / sponsor ID
- EH22-492
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 800 participants (estimated)
- Lead sponsor
- Endeavor HealthUniversity, hospital or other
- Study start
- 25 Apr 2023 (actual)
- Primary completion
- Apr 2026 (estimated)
- Study completion
- Apr 2027 (estimated)
- First posted
- 3 Apr 2023 (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.
This is a prospective observational study. Investigators want to understand post-operative recovery for patients undergoing mastectomy at NorthShore University HealthSystem. Some of these patients receive PECS blocks with Liposomal Bupivacaine and some do not receive a block. Investigators want to know whether patients who receive a block have better post operative recovery and pain control than patients who do not receive one. Investigators also want to understand whether PECS blocks with Liposomal Bupivacaine improves quality of recovery at 72 hours post operatively.
Detailed description
Investigators plan to approach and consent 800 patients undergoing mastectomy, 400 with PECS blocks and 400 without. Investigators will assess their quality of recovery using the QoR 15 survey at 72 hours post operatively. In addition, investigators will also record VAS scores immediately postoperatively and at 24, 48, and 72 hours postoperatively. The study team will also calculate the total morphine equivalents (MMEs) required for each patient after 72 hours.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PECS Block with Liposomal Bupivacaine | – | Procedure: Mastectomy with PECS blocks, Drug: Liposomal bupivacaineThe patients in this cohort will undergo a PECS block with Liposomal Bupivacaine before their mastectomy. Patients will receive Liposomal Bupivacaine in combination with 0.25% Bupivacaine in a 1:1 mixture for the purpose of post-operative pain control. |
| No PECS block | – | –The patients in cohort will not undergo a PECS block. Pain will be controlled in the usual fashion with IV and oral medications. |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Females having mastectomy either for cancer diagnosis or prophylactic.
Key inclusion criteria (1 listed)
- Must be female Must be >18 years old and < 90 years old Must be able to consent in English or Spanish May or may not have breast cancer (prophylactic mastectomy) Must be undergoing unilateral or bilateral mastectomy of any type May choose to proceed with or without breast reconstruction
Key exclusion criteria (3 listed)
- Allergy to all narcotic or local anesthetic medications Intake of any chronic opioids or pain medications preoperatively for a chronic condition or chronic use.
- Subjects who received PECS blocks but whose block failed or is deemed not effective by an anesthesia provider as indicated by postoperative evaluation exam.
- Vulnerable subjects (children, prisoners, pregnant women)
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 |
|---|---|---|
| Mastectomy with PECS blocksApproximately half of patients recruited will receive a PECS block with Liposomal bupivacaine and half will not receive a block. | Procedure or surgery | PECS Block with Liposomal Bupivacaine |
| Liposomal bupivacaineAll of the PECS blocks performed at this institution have liposomal lupivacaine as the anesthetic. Investigators will examine quality of recovery and pain control in patients who receive a PECS block versus those who do not receive one. | Drug | PECS Block with Liposomal Bupivacaine |
Primary outcome
Quality of Recovery 15 Survey
Time frame: 72 hours post operatively
Patients will complete the quality of recovery 15 survey 72 hours after surgery. This is a scale from 0 to 150. A score of 150 indicates better post operative recovery.
8 secondary outcomes
Visual analog scale
Time frame: Immediately post operatively
Visual analog scale
Time frame: 24 hours post operatively
Visual analog scale
Time frame: 48 hours post operatively
Visual analog scale
Time frame: 72 hours post operatively
Morphine milligram equivalents
Time frame: Immediately post operatively
Morphine milligram equivalents
Time frame: 24 hours post operatively
Morphine milligram equivalents
Time frame: 48 hours post operatively
Morphine milligram equivalents
Time frame: 72 hours post operatively
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 23 Oct 2025.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
Katharine Yao, M.D. principal investigator
Endeavor Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Post Operative Pain and Quality of Recovery After Mastectomy, run by Endeavor Health 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 1 inclusion and 3 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: under way, not looking for participants, as of the sponsor's last update on 23 Oct 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.
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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Quality of Recovery 15 Survey (time frame: 72 hours post operatively). 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 23 Oct 2025.