Quality of Recovery From Mastectomy With and Without PECS Blocks

Post Operative Pain Clinical Trial

Official title:

Patient Quality of Recovery From Mastectomy With and Without PECS Block With Liposomal Bupivacaine

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05795413
• Other study ID #: EH22-492
• Status: Recruiting
• Start date: April 25, 2023
• Est. completion date: April 2027

Study information

• Verified date: October 2023
• Source: NorthShore University HealthSystem
• Contact: Mary Turk
• Phone: 847-570-1184
• Email: mturk[@]northshore.org
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 800
• Est. completion date: April 2027
• Est. primary completion date: April 2026
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 90 Years

Eligibility

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)

Related Conditions & MeSH terms

• Pain, Postoperative
• Post Operative Pain

Intervention

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.

Locations

Country	Name	City	State
United States	Evanston Hospital	Evanston	Illinois

Sponsors (1)

Lead Sponsor	Collaborator
NorthShore University HealthSystem

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Visual analog scale	This is a pain scale from zero to ten. A score of 10 indicates worse pain.	Immediately post operatively
Secondary	Visual analog scale	This is a pain scale from zero to ten. A score of 10 indicates worse pain.	24 hours post operatively
Secondary	Visual analog scale	This is a pain scale from zero to ten. A score of 10 indicates worse pain.	48 hours post operatively
Secondary	Visual analog scale	This is a pain scale from zero to ten. A score of 10 indicates worse pain.	72 hours post operatively
Secondary	Morphine milligram equivalents	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.	Immediately post operatively
Secondary	Morphine milligram equivalents	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.	24 hours post operatively
Secondary	Morphine milligram equivalents	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.	48 hours post operatively
Secondary	Morphine milligram equivalents	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.	72 hours post operatively