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

NCT07201987 — Phase 2, Not yet recruiting, 100 participants, Ganesh M. Shankar

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Registry	NCT07201987
Status	Not yet recruiting
Phase	Phase 2
Study type	Interventional; randomized, parallel, masking: double, treatment
Enrollment	100 (Estimated)
Sponsor	Ganesh M. Shankar (Other)
Conditions	Spine Surgery, Postoperative Pain Management
Interventions	Vancomycin (local, via calcium sulfate beads), Morphine (local, via calcium sulfate beads), Bupivacaine (local, via calcium sulfate beads) (Drug)
Dates	start 2027-01-01 (estimated), primary completion 2028-01-01 (estimated), completion 2028-01-01 (estimated), first posted 2025-10-01, last updated 2026-04-16

-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.

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+Arms and interventions

Arm	Type	Interventions	Description
Vancomycin-impregnated calcium sulfate beads with morphine and bupivacaine	Experimental	Drug: Vancomycin (local, via calcium sulfate beads); Drug: Morphine (local, via calcium sulfate beads); Drug: Bupivacaine (local, via calcium sulfate beads)	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.
Vancomycin-impregnated calcium sulfate beads (standard-of-care)	Active comparator	Drug: Vancomycin (local, via calcium sulfate beads)	Patients will receive intraoperative placement of vancomycin-impregnated calcium sulfate beads for surgical site infection prophylaxis, without added analgesics.

Vancomycin (local, via calcium sulfate beads) (Drug): Patients undergoing spine surgery will receive intraoperative placement of calcium sulfate beads impregnated with vancomycin. The beads are intended to provide local infection prophylaxis.
Morphine (local, via calcium sulfate beads) (Drug): 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.
Bupivacaine (local, via calcium sulfate beads) (Drug): 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.

+Outcome measures

Primary outcomes

Total Postoperative Analgesic Consumption in Morphine Milligram Equivalents (MME) [From end of surgery through 8 weeks post-surgery.]: Cumulative dose of opioids and non-opioid analgesics used postoperatively, converted to morphine milligram equivalents.
Change from Baseline in Postoperative Pain Intensity as Measured by PROMIS Pain Intensity Short Form 3a [Baseline (pre-surgery), 24-48 hours, 2-3 weeks, and 8 weeks post-surgery.]: Average change in self-reported pain intensity using the PROMIS Pain Intensity Short Form 3a, scored on a 0-10 scale (0 = no pain, 10 = worst possible pain).
Length of Hospital Stay [From the day of surgery until hospital discharge (typically 2-7 days postoperatively)]: Number of days from surgery to hospital discharge.
Change from Baseline in Functional Status as Measured by PROMIS Physical Function Short Form 10a [Baseline (pre-surgery), 2-3 weeks, and 8 weeks post-surgery.]: Change in physical function as reported by participants using the PROMIS Physical Function Short Form 10a. Scores are reported as T-scores (mean = 50, SD = 10); higher scores indicate better function.
Change from Baseline in Functional Status as Measured by Oswestry Disability Index (ODI) [Baseline (pre-surgery), 2-3 weeks, and 8 weeks post-surgery.]: Change in disability as reported by participants using the Oswestry Disability Index (ODI). Scores range from 0 to 100; higher scores indicate greater disability.

Secondary outcomes

Incidence of Surgical Site Infections [Within 8 weeks post-surgery.]: Number of participants with a postoperative surgical site infection, defined by CDC criteria.

+Eligibility

Sex: All, ages: 18 Years to any

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

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