Quality of Recovery From Mastectomy With and Without PECS Blocks

NCT05795413 | Active Not Recruiting FDA Drug

• 1 other identifier: EH22-492
• Study Type: observational
• Target: 800
• Locations: 1 country
• Sites: 1

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.

Conditions

Post Operative Pain; Quality of Recovery After Mastectomy

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (8)

• Visual analog scale

  Immediately post operatively

• Visual analog scale

  24 hours post operatively

• Visual analog scale

  48 hours post operatively

• Visual analog scale

  72 hours post operatively

• Morphine milligram equivalents

  Immediately post operatively

Study Arms (2)

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; 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.

Interventions

Mastectomy with PECS blocks PROCEDURE

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

PECS Block with Liposomal Bupivacaine

Liposomal bupivacaine DRUG

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.

PECS Block with Liposomal Bupivacaine

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Females having mastectomy either for cancer diagnosis or prophylactic.

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Endeavor Health: lead

Study Sites (1)

Evanston Hospital

Evanston, Illinois, 60201, United States

Location

MeSH Terms

Conditions

Pain, Postoperative

Interventions

Mastectomy

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Surgical Procedures, Operative

Study Officials

• Katharine Yao, M.D.

  Endeavor Health

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief, Division of Surgical Oncology Vice Chair, Research and Development

Study Record Dates

• First Submitted: March 8, 2023
• First Posted: April 3, 2023
• Study Start: April 25, 2023
• Primary Completion: April 1, 2026
• Study Completion (Estimated): April 1, 2027
• Last Updated: October 23, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)