Quality of Recovery From Mastectomy With and Without PECS Blocks

Sponsor
NorthShore University HealthSystem (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05795413
Collaborator
(none)
800
48

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Procedure: Mastectomy with PECS blocks
  • Drug: Liposomal bupivacaine

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 Design

Study Type:
Observational
Anticipated Enrollment :
800 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Patient Quality of Recovery From Mastectomy With and Without PECS Block With Liposomal Bupivacaine
Anticipated Study Start Date :
Mar 1, 2023
Anticipated Primary Completion Date :
Mar 1, 2026
Anticipated Study Completion Date :
Mar 1, 2027

Arms and Interventions

Arm Intervention/Treatment
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.

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.

No PECS block

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

Outcome Measures

Primary Outcome Measures

  1. 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

  1. Visual analog scale [Immediately post operatively]

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

  2. Visual analog scale [24 hours post operatively]

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

  3. Visual analog scale [48 hours post operatively]

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

  4. Visual analog scale [72 hours post operatively]

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

  5. Morphine milligram equivalents [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 [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 [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 [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 90 Years
Sexes Eligible for Study:
Female
Accepts Healthy Volunteers:
Yes
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)

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • NorthShore University HealthSystem

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Katharine Yao, MD, Chief, Division of Surgical Oncology Vice Chair, Research and Development, NorthShore University HealthSystem
ClinicalTrials.gov Identifier:
NCT05795413
Other Study ID Numbers:
  • EH22-492
First Posted:
Apr 3, 2023
Last Update Posted:
Apr 3, 2023
Last Verified:
Mar 1, 2023
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
Yes
Studies a U.S. FDA-regulated Device Product:
No
Product Manufactured in and Exported from the U.S.:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Apr 3, 2023