Pain, Postoperative Clinical Trial
Official title:
A Phase 2 Randomized Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of a Single Intrathecal Preoperative Administration of Brivoligide Injection in Patients With a Pain Catastrophizing Scale Score ≥16 Undergoing Unilateral Total Knee Arthroplasty
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.
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