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Completed

NCT Number: NCT03181139

Efficacy of Enhanced Recovery After Surgery Pathway for Total Mastectomy

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

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Key information

Conditions

Mastectomy Breast Cancer Female

Age range

18 year and older

Sex eligibility

Female

Study type

Observational

About this study

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.

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

ERAS pathway for Total Mastectomy

Other

Enhanced Recovery after Surgery (ERAS) pathway for Total Mastectomy

Primary outcomes

  1. perioperative opioid consumption

    Time frame: through study completion (average of 1 year)

    perioperative opioid consumption

Secondary outcomes

  1. Post-operative nausea and vomiting (PONV)

    Time frame: through study completion (average of 1 year)

    incidence post-operative nausea and vomiting

  2. postoperative benzodiazepine use

    Time frame: through study completion (average of 1 year)

    amount of benzodiazepines used postoperatively for treatment of muscle spasm

  3. Length of stay (LOS)

    Time frame: through study completion (average of 1 year)

    Length of stay

  4. Pain score

    Time frame: through study completion (average of 1 year)

    highest pain score perioperatively

  5. Surgery duration

    Time frame: through study completion (average of 1 year)

    length of surgery (min)

Sponsors and collaborators

Lead sponsor

Monica Harbell

Other

Collaborators

  • Mount Zion Health Fund

Registry information

Acronym: ERAS_Breast

Important dates

Study start
2013
Primary completion
2016
Study completion
2016
First posted
Jun 8, 2017
Registry last updated
Jun 8, 2017

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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