drugset / Trial / NCT07201987

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

NCT07201987

Phase 2 Not yet recruiting 100 enrolled Ganesh M. Shankar
RandomizedParallel-groupDouble-blindTreatment

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.

Timeline

Start
2027-01-01
Primary completion
2028-01-01
Completion
2028-01-01

Drugs

EvaluationDrugModalityDoseRoute
Subject Bupivacaine Other / unclassified Other
Subject Morphine Other / unclassified Other
Background Vancomycin Other / unclassified Other

Indications

No indication recorded.