This is a multiple center, randomized, double-blind, placebo-controlled study to evaluate the safety and efficacy of brivoligide injection administered intrathecally before surgery in patients with high Pain Catastrophizing Scale (PCS) scores undergoing mastectomy with immediate tissue expander or implant placement.
Potential subjects will be prescreened for PCS score; pre-qualified patients will be invited to the investigative site for informed consent and full screening within 30 days of randomization. Patients providing informed consent and meeting all study eligibility criteria will be enrolled in the study on the day of surgery (Day 1). Subjects will receive study drug just prior to anesthesia induction. Study assessments will be entered by subjects in the electronic diary from Day 1 through Day 21. Follow-up visits will occur on Days 7 and 21 (± 2 days).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Single preoperative intrathecal injection
Single preoperative intrathecal injection
Pain with general movement involving the chest and upper body
Least Squares (LS) Mean pain rating with general movement involving the chest and upper body on the 0 - 10 Numerical Rating Scale (0 = No Pain; 10 = Worst Pain)
Time frame: Day 3 to Day 14
Pain at rest
Least Squares (LS) Mean pain rating at rest on the 0 - 10 Numerical Rating Scale (0 = No Pain; 10 = Worst Pain)
Time frame: Day 3 to Day 14
Pain with deep full inspiration and forceful effective cough
Least Squares (LS) Mean pain rating with deep full inspiration and forceful effective cough on the 0 - 10 Numerical Rating Scale (0 = No Pain; 10 = Worst Pain)
Time frame: Day 3 to Day 14
Pain with ipsilateral arm abduction
Least Squares (LS) Mean pain rating with ipsilateral arm abduction on the 0 - 10 Numerical Rating Scale (0 = No Pain; 10 = Worst Pain)
Time frame: Day 14 to Day 21
Total use of postoperative opioid medications
Total use (median) of postoperative opioid medications (morphine equivalents)
Time frame: Day 3 to Day 14
Total use of postoperative opioid medications
Total use (median) of postoperative opioid medications (morphine equivalents)
Time frame: Day 1 through Day 21
Change from baseline for the BREAST-Q
Change from baseline to Day 21 for the BREAST-Q
Time frame: Screening to Day 21
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