NCT07201987

Intraoperative Placement of Vancomycin-impregnated Calcium Sulfate Beads Conjugated With Analgesics to Improve Spine Surgery Outcomes

• Status: Not Yet Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 100 (estimated)
• Sponsor: Ganesh M. Shankar · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The goal of this clinical trial is to learn if using calcium sulfate beads that contain vancomycin (an antibiotic) and pain-relieving medicines during spine surgery can improve recovery compared to standard care with intravenous (IV) morphine and local pain medicines. Researchers want to know if the sustained release formulation of morphine from these calcium sulfate beads affect: * Postoperative length of stay * Postoperative pain scores * Postoperative narcotic analgesic requirements All participants in this study will already be scheduled to have spine surgery as part of their regular medical care. During surgery, participants will be assigned to receive either intraoperative placement of calcium sulfate beads with vancomycin alone or vancomycin with morphine and bupivacaine. All patients will still have access to standard of care with IV and PO pain regimens. Participants will then be followed after surgery to measure their pain, recovery, and medication use. Participation is voluntary, and choosing not to join will not affect a person's medical care.

Conditions

• Spine Surgery
• Postoperative Pain Management

Interventions

Type	Name	Description
DRUG	Vancomycin (local, via calcium sulfate beads)	Patients undergoing spine surgery will receive intraoperative placement of calcium sulfate beads impregnated with vancomycin. The beads are intended to provide local infection prophylaxis.
DRUG	Morphine (local, via calcium sulfate beads)	Patients undergoing spine surgery in the experimental arm will receive intraoperative placement of calcium sulfate beads impregnated with morphine. The beads are intended to provide sustained local analgesia.
DRUG	Bupivacaine (local, via calcium sulfate beads)	Patients undergoing spine surgery in the experimental arm will receive intraoperative placement of calcium sulfate beads impregnated with bupivacaine. The beads are intended to provide sustained local analgesia.

Timeline

• Start date: 2027-01-01
• Primary completion: 2028-01-01
• Completion: 2028-01-01
• First posted: 2025-10-01
• Last updated: 2026-04-16

Regulatory

• FDA-regulated drug study