Clinical trial NCT05795413: Quality of Recovery From Mastectomy With and Without PECS Blocks
Official title: Patient Quality of Recovery From Mastectomy With and Without PECS Block With Liposomal Bupivacaine
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Post Operative Pain
Quality of Recovery After Mastectomy
Lead sponsor: Endeavor Health
Sponsor class: OTHER
First posted: 2023-04-03
Enrollment: 800
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Females having mastectomy either for cancer diagnosis or prophylactic.

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.

Eligibility criteria: 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)

Primary outcomes:
measure: Quality of Recovery 15 Survey
timeFrame: 72 hours post operatively
Secondary outcomes:
measure: Visual analog scale
timeFrame: Immediately post operatively
measure: Visual analog scale
timeFrame: 24 hours post operatively
measure: Visual analog scale
timeFrame: 48 hours post operatively
measure: Visual analog scale
timeFrame: 72 hours post operatively
measure: Morphine milligram equivalents
timeFrame: Immediately post operatively
measure: Morphine milligram equivalents
timeFrame: 24 hours post operatively
measure: Morphine milligram equivalents
timeFrame: 48 hours post operatively
measure: Morphine milligram equivalents
timeFrame: 72 hours post operatively
Other outcomes:
Locations:
city: Evanston
country: United States
facility: Evanston Hospital
state: Illinois
Study officials:
affiliation: Endeavor Health
name: Katharine Yao, M.D.
role: PRINCIPAL_INVESTIGATOR
References: