Quality of Recovery From Mastectomy With and Without PECS Blocks

Endeavor Health

Status: Active, not recruiting

Conditions: Quality of Recovery After Mastectomy; Post Operative Pain

Treatments: Drug: Liposomal bupivacaine; Procedure: Mastectomy with PECS blocks

Study type: Observational

Funder types: Other

Identifiers

NCT05795413

EH22-492

Details and patient eligibility

About

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.

Full 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.

Enrollment: 800 estimated patients

Sex: Female

Ages: 18 to 90 years old

Volunteers: Accepts Healthy Volunteers

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)

Trial design

800 participants in 2 patient groups

PECS Block with Liposomal Bupivacaine

Description:

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.

Treatment:

Procedure: Mastectomy with PECS blocks

Drug: Liposomal bupivacaine

No PECS block

Description:

The patients in cohort will not undergo a PECS block. Pain will be controlled in the usual fashion with IV and oral medications.