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WITHDRAWN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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