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NCT Number: NCT05795413

Quality of Recovery From Mastectomy With and Without PECS Blocks

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.

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This study is active but is not currently recruiting participants.

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Key information

Conditions

Post Operative Pain Neurologic Manifestations Pain Pain, Postoperative Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Quality of Recovery After Mastectomy Signs and Symptoms

Age range

18 year–90 year

Sex eligibility

Female

Study type

Observational

Primary location

Evanston Hospital

Evanston, Illinois, 60201, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Mastectomy with PECS blocks

Procedure

Approximately half of patients recruited will receive a PECS block with Liposomal bupivacaine and half will not receive a block.

Liposomal bupivacaine

Drug

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.

Primary outcomes

  1. 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

  1. Visual analog scale

    Time frame: Immediately post operatively

    This is a pain scale from zero to ten. A score of 10 indicates worse pain.

  2. Visual analog scale

    Time frame: 24 hours post operatively

    This is a pain scale from zero to ten. A score of 10 indicates worse pain.

  3. Visual analog scale

    Time frame: 48 hours post operatively

    This is a pain scale from zero to ten. A score of 10 indicates worse pain.

  4. Visual analog scale

    Time frame: 72 hours post operatively

    This is a pain scale from zero to ten. A score of 10 indicates worse pain.

  5. Morphine milligram equivalents

    Time frame: Immediately 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.

  6. Morphine milligram equivalents

    Time frame: 24 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.

  7. Morphine milligram equivalents

    Time frame: 48 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.

  8. Morphine milligram equivalents

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Endeavor Health

Other

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2026
Study completion
2027
First posted
Apr 3, 2023
Registry last updated
Oct 23, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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