NCT05795413

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
• Phase: —
• Study type: Observational
• Enrollment: 800 (estimated)
• Sponsor: Endeavor Health · Academic / Other
• Sex: Female
• Age: 18 Years – 90 Years
• Healthy volunteers: Accepted

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.

Conditions

• Post Operative Pain
• Quality of Recovery After Mastectomy

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2023-04-25
• Primary completion: 2026-04-01
• Completion: 2027-04-01
• First posted: 2023-04-03
• Last updated: 2025-10-23

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study