This is a multi-center, Phase 2, randomized, double-blind, placebo-controlled study to evaluate the safety and efficacy of brivoligide injection administered intrathecally before surgery in patients with a Pain Catastrophizing Scale (PCS) score ≥16 undergoing primary unilateral total knee arthroplasty.
The objective of this study is to evaluate the safety and postoperative pain reducing efficacy of a single preoperative intrathecal administration of brivoligide injection in patients with a Pain Catastrophizing Scale (PCS) score ≥16 undergoing unilateral total knee arthroplasty. Potential subjects will be prescreened for PCS scores of 16 or greater in advance; 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). Safety assessments will be performed through Day 28; efficacy assessments will be conducted at the follow-up visits and daily via electronic diary by subjects through Day 42. Follow up visits will occur on Days 7, 14, 21, 28, and 42.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Single preoperative intrathecal injection
Single preoperative intrathecal injection
Research Site
Sheffield, Alabama, United States
Research Site
Phoenix, Arizona, United States
Numerical Rating Scale (NRS) Pain with Walking 15 Meters
Least squares mean pain rating (NRS) with walking during the 15-meter walk Day 7 to Day 28
Time frame: Day 7 to Day 28
Numerical Rating Scale (NRS) Pain at Rest
Least squares mean pain rating (NRS) at rest Day 7 to Day 28
Time frame: Day 7 to Day 28
Numerical Rating Scale (NRS) Pain with 90 Degrees Passive Knee Flexion
Least squares mean pain rating (NRS) with passive knee flexion to 90 degrees from Day 7 to Day 28
Time frame: Day 7 to Day 28
Total Postoperative Opioid Use
Total use of postoperative opioid medications (morphine equivalents) to Day 42
Time frame: Postoperative through Day 42
Time to Numerical Rating Scale (NRS) Pain ≤ 3 for Worst Pain
Time to achieve NRS pain score ≤ 3 for worst pain
Time frame: Postoperative through Day 42
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