Status:
COMPLETED
Preoperative Regional Nerve Block for Acute and Chronic Post-Operative Pain Following Mastectomy
Lead Sponsor:
University of Alabama at Birmingham
Conditions:
Breast Cancer
Mastectomy
Eligibility:
FEMALE
19+ years
Phase:
EARLY_PHASE1
Brief Summary
The purpose of this study is to see if pre-operative regional nerve blocks compared to a placebo nerve block can decrease chronic post mastectomy pain, immediate postoperative pain and postoperative n...
Detailed Description
Surgical intervention of breast cancer is vital to breast cancer treatment or prevention and patient outcomes. However, surgical therapy can lead to chronic pain that may affect quality of life for br...
Eligibility Criteria
Inclusion
- Women at least 19 years old who are able to provide written and informed consent
- Women undergoing unilateral or bilateral, simple, skin-sparing, or nipple sparing mastectomy for breast cancer (Stage 0-III) or breast cancer prevention
- Patients with ASA class of I-III will be included
Exclusion
- Stage IV breast cancer, morbid obesity with BMI \>45kg/m2
- Renal insufficiency (Creatinine \>1.5 mg/dL)
- Current chronic analgesic use (daily use for \> or equal to 4 weeks)
- History of opioid abuse or dependence
- Presence of chronic pain with a self-reported average pain score of 4 or greater on a pain scale of 0-10 prior to any surgical intervention
- Incarceration
- Pregnancy
- Immediate autologous tissue reconstruction.
Key Trial Info
Start Date :
July 6 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 25 2021
Estimated Enrollment :
21 Patients enrolled
Trial Details
Trial ID
NCT04019834
Start Date
July 6 2020
End Date
November 25 2021
Last Update
August 3 2022
Active Locations (1)
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1
University of Alabama at Birmingham Hospitals and Affiliated Clinics
Birmingham, Alabama, United States, 35233