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

Ganesh M. Shankar

Status and phase: Not yet enrolling; Phase 2

Conditions: Spine Surgery; Postoperative Pain Management

Treatments: Drug: Bupivacaine (local, via calcium sulfate beads); Drug: Morphine (local, via calcium sulfate beads); Drug: Vancomycin (local, via calcium sulfate beads)

Study type: Interventional

Funder types: Other

Identifiers

NCT07201987

2025p001993

Details and patient eligibility

About

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.

Enrollment: 100 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Age ≥ 18 years
• Able to understand and provide consent in English
• Undergoing elective lumbar spinal decompression and fusion surgery at one or two levels

Exclusion criteria

• History of allergy or hypersensitivity to morphine, bupivacaine, or calcium sulfate.
• Active systemic or localized infection at the surgical site.
• History of chronic opioid dependence or opioid use disorder (as it may confound pain assessment).
• Patients with severe renal or hepatic impairment (due to altered metabolism of analgesics and risk of complications from analgesic side effects).
• Pregnant or breastfeeding individuals.
• Filling of defects that are intrinsic to the stability of the bony structure
• Severe vascular or neurological disease
• Uncontrolled diabetes
• Severe degenerative bone disease
• Hypercalcemia

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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100 participants in 2 patient groups

Vancomycin-impregnated calcium sulfate beads with morphine and bupivacaine

Experimental group

Description:

Patients will receive intraoperative placement of vancomycin-impregnated calcium sulfate beads conjugated with morphine and bupivacaine for pain control, in addition to standard perioperative care.

Treatment:

Drug: Vancomycin (local, via calcium sulfate beads)

Drug: Morphine (local, via calcium sulfate beads)

Drug: Bupivacaine (local, via calcium sulfate beads)

Vancomycin-impregnated calcium sulfate beads (standard-of-care)

Active Comparator group

Description:

Patients will receive intraoperative placement of vancomycin-impregnated calcium sulfate beads for surgical site infection prophylaxis, without added analgesics.

Treatment:

Drug: Vancomycin (local, via calcium sulfate beads)