Efficacy of Enhanced Recovery After Surgery Pathway for Total Mastectomy

Breast Cancer Female Clinical Trial

— ERAS_Breast  

Official title:

Efficacy of Enhanced Recovery After Surgery Pathway for Total Mastectomy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03181139
• Other study ID #: ERASBreast
• Status: Completed
• Phase: N/A
• First received: June 2, 2017
• Last updated: June 6, 2017
• Start date: July 1, 2013
• Est. completion date: April 30, 2016

Study information

• Verified date: June 2017
• Source: University of California, San Francisco
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Retrospective analysis of pre and post-Enhanced Recovery after Surgery for Total mastectomy pathway implementation.

Description:

Retrospective analysis of pre- and post-Enhanced Recovery after surgery for total mastectomy pathway implementation in patients at Mount Zion Hospital. We examined perioperative opioid consumption, pain scores, post-operative nausea and vomiting, benzodiazepine use, length of stay for the time period before and after implementation of an Enhanced Recovery after Surgery pathway for Total mastectomy. Pathway features included preoperative acetaminophen and gabapentin, minimizing opioids, postoperative NSAIDs, Pecs blocks, and aggressive postoperative nausea and vomiting prophylaxis.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 386
• Est. completion date: April 30, 2016
• Est. primary completion date: April 30, 2016
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• female patients at least 18 years old undergoing total skin sparing mastectomy at University of California San Francisco Mount Zion hospital

Exclusion Criteria:

• patients undergoing concurrent bilateral salpingo-oophorectomy, flap reconstruction

Related Conditions & MeSH terms

• Breast Cancer Female
• Mastectomy

Intervention

Other:
• ERAS pathway for Total Mastectomy
Enhanced Recovery after Surgery (ERAS) pathway for Total Mastectomy

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Monica Harbell	Mount Zion Health Fund

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	perioperative opioid consumption	perioperative opioid consumption	through study completion (average of 1 year)
Secondary	Post-operative nausea and vomiting (PONV)	incidence post-operative nausea and vomiting	through study completion (average of 1 year)
Secondary	postoperative benzodiazepine use	amount of benzodiazepines used postoperatively for treatment of muscle spasm	through study completion (average of 1 year)
Secondary	Length of stay (LOS)	Length of stay	through study completion (average of 1 year)
Secondary	Pain score	highest pain score perioperatively	through study completion (average of 1 year)
Secondary	Surgery duration	length of surgery (min)	through study completion (average of 1 year)