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NCT Number: NCT07201987

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

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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Key information

Conditions

Spine Surgery Postoperative Pain Management

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. Total Postoperative Analgesic Consumption in Morphine Milligram Equivalents (MME)

    Time frame: From end of surgery through 8 weeks post-surgery.

    Cumulative dose of opioids and non-opioid analgesics used postoperatively, converted to morphine milligram equivalents.

  2. Change from Baseline in Postoperative Pain Intensity as Measured by PROMIS Pain Intensity Short Form 3a

    Time frame: 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).

  3. Length of Hospital Stay

    Time frame: From the day of surgery until hospital discharge (typically 2-7 days postoperatively)

    Number of days from surgery to hospital discharge.

  4. Change from Baseline in Functional Status as Measured by PROMIS Physical Function Short Form 10a

    Time frame: 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.

  5. Change from Baseline in Functional Status as Measured by Oswestry Disability Index (ODI)

    Time frame: 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

  1. Incidence of Surgical Site Infections

    Time frame: Within 8 weeks post-surgery.

    Number of participants with a postoperative surgical site infection, defined by CDC criteria.

Study contacts

Contact information is provided by the study sponsor or research team.

Ganesh Shankar, MD, PhD

CONTACT

[email protected]

617-724-1099

Sponsors and collaborators

Lead sponsor

Ganesh M. Shankar

Other

Registry information

Important dates

Study start
2027
Primary completion
2028
Study completion
2028
First posted
Oct 1, 2025
Registry last updated
Apr 16, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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