Patient Quality of Recovery From Mastectomy With and Without PECS Block With Liposomal Bupivacaine
Overview
- Phase
- Not Applicable
- Intervention
- Mastectomy with PECS blocks
- Conditions
- Post Operative Pain
- Sponsor
- Endeavor Health
- Enrollment
- 800
- Locations
- 1
- Primary Endpoint
- Quality of Recovery 15 Survey
- Status
- Active, not recruiting
- Last Updated
- 6 months ago
Overview
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.
Investigators
Katharine Yao, MD
Chief, Division of Surgical Oncology Vice Chair, Research and Development
Endeavor Health
Eligibility Criteria
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)
Arms & Interventions
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.
Intervention: Mastectomy with PECS blocks
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.
Intervention: Liposomal bupivacaine
Outcomes
Primary Outcomes
Quality of Recovery 15 Survey
Time Frame: 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 Outcomes
- Visual analog scale(72 hours post operatively)
- Morphine milligram equivalents(72 hours post operatively)