Development of a bupivacaine sustained release formulation for non-opioid analgesia following instrumented spinal surgery

Background: Patients undergoing instrumented spine surgery experience severe pain. Current opioid-based pain treatment provides a delicate balance between analgesic effect and side effects, delaying recovery. Local anesthetics such as bupivacaine have the potential to provide non-opioid pain relief, but are hampered by rapid systemic absorption and a duration of action that does not match the duration of severe pain. To enhance recovery after surgery through sustained and precise non-opioid pain treatment, BR-003 was developed. BR-003 is a ring-shaped hydrogel sustained-release formulation of bupivacaine suitable for co-implantation with pedicle screws, and is expected to provide precise treatment of postoperative pain. The objective is to describe the preclinical development of BR-003, and to assess its safety and feasibility in a large animal model.