Status:

WITHDRAWN

Speeding Recovery From Pain and Opioid Use

Lead Sponsor:

Wake Forest University Health Sciences

Conditions:

Pain, Postoperative

Breast Cancer

Eligibility:

FEMALE

18+ years

Phase:

EARLY_PHASE1

Brief Summary

Surgical treatment of breast cancer is associated with significant disability, and pain is often reported as a primary cause for declines in the ability to perform activities of daily living. However,...

Detailed Description

Surgical treatment of breast cancer is associated with significant disability, and pain is often reported as a primary cause for declines in the ability to perform activities of daily living. Surgical...

Eligibility Criteria

Inclusion

  • Patients scheduled for unilateral mastectomy with immediate issue expander and implant based reconstruction.
  • Age ≥ 18 years
  • Ability to understand, read, and write English, and the willingness to sign an IRB-approved informed consent document.
  • Patients who receive a tissue expander placement will be included in the study.
  • American Society of Anesthesiologists physical status I-III patients.

Exclusion

  • Patients who receive an autologous tissue reconstruction.
  • Patients who receive a bilateral reconstruction.
  • Patients who receive a direct to permanent implant reconstruction
  • Patients with diagnosis of opioid misuse disorder or on high dose opioid therapy (greater than 100 mg equivalents of oral morphine per day)
  • Patients who are wards of the state
  • Patients who cannot read or speak English
  • History of allergic reactions attributed to compounds with known or suspected cross-sensitivity to bupivacaine.
  • Pregnant or breast feeding
  • Inability to access to the internet on a daily basis

Key Trial Info

Start Date :

November 1 2018

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

June 1 2020

Estimated Enrollment :

Patients enrolled

Trial Details

Trial ID

NCT03388814

Start Date

November 1 2018

End Date

June 1 2020

Last Update

November 30 2018

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