Speeding Recovery From Pain and Opioid Use

• Status: Withdrawn
• Trial end date: 2020-06-01
• Target enrollment: 0
• Participant gender: Female

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, breast reconstruction at the same time as mastectomy has been linked to higher postoperative pain, which can be a risk factor for persistent pain. The goal of this study is to determine the speed of recovery from pain and opioid use in the first 2 months after breast surgery and reconstruction.

• Phase: Early Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Wake Forest University Health Sciences
• Treatments: Bupivacaine

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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