Quality of Recovery From Mastectomy With and Without PECS Blocks

Recruiting

• Conditions: Post Operative Pain; Quality of Recovery After Mastectomy
• Interventions: Procedure: Mastectomy with PECS blocks; Drug: Liposomal bupivacaine

• Registration Number: NCT05795413
• Lead Sponsor: NorthShore University HealthSystem

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.

Study Timeline

• Study First Submitted: 2023-03-08
• Study First Submitted QC: 2023-03-20
• Study First Posted: 2023-04-03
• Study Start: 2023-04-25
• Status Verified: 2023-10
• Last Update Submitted: 2023-10-16
• Last Update Posted: 2023-10-18
• Primary Completion: 2026-04
• Study Completion: 2027-04

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 800

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

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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)

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
PECS Block with Liposomal Bupivacaine	Mastectomy with PECS blocks	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.
PECS Block with Liposomal Bupivacaine	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.

Primary Outcome Measures

Name	Time	Method
Quality of Recovery 15 Survey	72 hours post operatively	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.

Secondary Outcome Measures

Name	Time	Method
Visual analog scale	72 hours post operatively	This is a pain scale from zero to ten. A score of 10 indicates worse pain.
Morphine milligram equivalents	72 hours post operatively	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.

Trial Locations

Locations (1)

Evanston Hospital; 🇺🇸 Evanston, Illinois, United States