Efficacy of Enhanced Recovery After Surgery Pathway for Total Mastectomy

Completed

• Conditions: Mastectomy; Breast Cancer Female
• Interventions: Other: ERAS pathway for Total Mastectomy

• Registration Number: NCT03181139
• Lead Sponsor: Monica Harbell

Brief Summary

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

Detailed 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.

Study Timeline

• Study Start: 2013-07-01
• Primary Completion: 2016-04-30
• Study Completion: 2016-04-30
• Status Verified: 2017-06
• Study First Submitted: 2017-06-02
• Study First Submitted QC: 2017-06-06
• Last Update Submitted: 2017-06-06
• Study First Posted: 2017-06-08
• Last Update Posted: 2017-06-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 386

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
post-ERAS	ERAS pathway for Total Mastectomy	patients cared for after the implementation of the Enhanced Recovery after surgery for total mastectomy pathway. Pathway included preoperative acetaminophen and gabapentin, Pec blocks, multimodal analgesia postoperatively and aggressive PONV treatment.

Primary Outcome Measures

Name	Time	Method
perioperative opioid consumption	through study completion (average of 1 year)	perioperative opioid consumption

Secondary Outcome Measures

Name	Time	Method
postoperative benzodiazepine use	through study completion (average of 1 year)	amount of benzodiazepines used postoperatively for treatment of muscle spasm
Post-operative nausea and vomiting (PONV)	through study completion (average of 1 year)	incidence post-operative nausea and vomiting
Length of stay (LOS)	through study completion (average of 1 year)	Length of stay
Pain score	through study completion (average of 1 year)	highest pain score perioperatively
Surgery duration	through study completion (average of 1 year)	length of surgery (min)