Quality of Recovery From Mastectomy With and Without PECS Blocks

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.

Study Overview

• Status: Recruiting
• Conditions: Post Operative Pain; Quality of Recovery After Mastectomy
• Intervention / Treatment: Procedure: Mastectomy with PECS blocks; Drug: Liposomal bupivacaine

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 Type: Observational
• Enrollment (Estimated): 800

Contacts and Locations

• Study Contact: Name: Mary Turk; Phone Number: 847-570-1184; Email: mturk@northshore.org

Study Locations

• United States
  • Illinois
    • Evanston, Illinois, United States, 60201
      • Recruiting
      • Evanston Hospital
      • Contact: Mary Turk; Phone Number: 847-570-1184

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 90 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

Females having mastectomy either for cancer diagnosis or prophylactic.

Description

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)

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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.	Procedure: Mastectomy with PECS blocks; Approximately half of patients recruited will receive a PECS block with Liposomal bupivacaine and half will not receive a block.; Drug: Liposomal 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.
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 the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	72 hours post operatively

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Visual analog scale	This is a pain scale from zero to ten. A score of 10 indicates worse pain.	Immediately post operatively
Visual analog scale	This is a pain scale from zero to ten. A score of 10 indicates worse pain.	24 hours post operatively
Visual analog scale	This is a pain scale from zero to ten. A score of 10 indicates worse pain.	48 hours post operatively
Visual analog scale	This is a pain scale from zero to ten. A score of 10 indicates worse pain.	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.	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.	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.	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.	72 hours post operatively

Collaborators and Investigators

• Sponsor: NorthShore University HealthSystem
• Investigators: Principal Investigator: Katharine Yao, M.D., NorthShore University HealthSystem

Study record dates

Study Major Dates

• Study Start (Actual): April 25, 2023
• Primary Completion (Estimated): April 1, 2026
• Study Completion (Estimated): April 1, 2027

Study Registration Dates

• First Submitted: March 8, 2023
• First Submitted That Met QC Criteria: March 20, 2023
• First Posted (Actual): April 3, 2023

Study Record Updates

• Last Update Posted (Actual): October 18, 2023
• Last Update Submitted That Met QC Criteria: October 16, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Pain; Neurologic Manifestations; Pain, Postoperative; Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Sensory System Agents; Anesthetics; Anesthetics, Local; Bupivacaine
• Other Study ID Numbers: EH22-492

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No