Pain, Postoperative
Conditions
Keywords
Mastectomy
Brief summary
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.
Detailed description
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).
Interventions
Single preoperative intrathecal injection
DRUGPlacebo 6 mL
Single preoperative intrathecal injection
Sponsors
Adynxx, Inc.
National Institute on Drug Abuse (NIDA)
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* Score of 16 or greater on the PCS scale * Scheduled to undergo unilateral or bilateral mastectomy with immediate tissue expander or implant placement * American Society of Anesthesiologists Physical Status Classification System ≤ 3 * Medically stable for this surgery with general anesthesia and intrathecal administration of study drug as determined by the Investigator * Body mass index of 18-45 kg/m2 * Have a stable medical regimen (for prescribed medications) for ≥ 7 days before randomization * Able to read and understand study instructions in English or Spanish, and willing and able to comply with all study procedures
Exclusion criteria
* Prior breast surgery in the index breast (either breast for bilateral surgery) in the last two years, other than biopsies and small/moderate volume lumpectomies * Induction chemotherapy or plans for adjunctive chemotherapy or any radiotherapy within 21 days of surgery * Known spinal deformities or cutaneous infection in the lumbar area that would preclude intrathecal administration of study drug * Planned use of liposomal formulated or long-acting local anesthetics, extended release opioid formulations (e.g., Oxycontin), long half-life opioids (e.g., methadone), or drugs with potential for adverse cognitive or memory effects (e.g., ketamine, scopolamine, or propranolol) preoperatively and/or at any time through the duration of the study * Use of more than 40 mg per day (on average) of oral morphine or its equivalent within 1 month prior to randomization * Current neurologic disorder, which could confound the assessment of pain * Unstable mental condition which would prevent the patient from understanding the nature and scope of the study and/or evidence of an uncooperative attitude in the opinion of the Investigator * Women who are pregnant or nursing * Participation in a clinical trial with the last dose or intervention within 1 month of randomization, or planned treatment in a clinical trial during this study * Previous participation in any study involving brivoligide injection
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pain with general movement involving the chest and upper body | Day 3 to Day 14 | 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) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Pain at rest | Day 3 to Day 14 | Least Squares (LS) Mean pain rating at rest on the 0 - 10 Numerical Rating Scale (0 = No Pain; 10 = Worst Pain) |
| Pain with deep full inspiration and forceful effective cough | Day 3 to Day 14 | 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) |
| Pain with ipsilateral arm abduction | Day 14 to Day 21 | Least Squares (LS) Mean pain rating with ipsilateral arm abduction on the 0 - 10 Numerical Rating Scale (0 = No Pain; 10 = Worst Pain) |
| Total use of postoperative opioid medications | Day 3 to Day 14 | Total use (median) of postoperative opioid medications (morphine equivalents) |
| Change from baseline for the BREAST-Q | Screening to Day 21 | Change from baseline to Day 21 for the BREAST-Q |
Outcome results
None listed