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Quality of Recovery From Mastectomy With and Without PECS Blocks

Patient Quality of Recovery From Mastectomy With and Without PECS Block With Liposomal Bupivacaine

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05795413
Enrollment
800
Registered
2023-04-03
Start date
2023-04-25
Completion date
2027-04-30
Last updated
2025-10-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Post Operative Pain, Quality of Recovery After Mastectomy

Brief 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. 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.

Interventions

PROCEDUREMastectomy with PECS blocks

Approximately half of patients recruited will receive a PECS block with Liposomal bupivacaine and half will not receive a block.

DRUGLiposomal bupivacaine

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.

Sponsors

Endeavor Health
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 90 Years
Healthy volunteers
Yes

Inclusion criteria

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

Exclusion criteria

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)

Design outcomes

Primary

MeasureTime frameDescription
Quality of Recovery 15 Survey72 hours post operativelyPatients 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.

Secondary

MeasureTime frameDescription
Visual analog scaleImmediately post operativelyThis is a pain scale from zero to ten. A score of 10 indicates worse pain.
Morphine milligram equivalentsImmediately post operativelyWe 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.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026