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Not yet recruiting NCT07201987

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

Phase II Interventional Spine Surgery Postoperative Pain Management

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Vancomycin (local, via calcium sulfate beads), Morphine (local, via calcium sulfate beads), Bupivacaine (local, via calcium sulfate beads).
Who it may be relevant to
Registry conditions: Spine Surgery, Postoperative Pain Management. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Overview

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.

Interventions

  • 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.

Primary outcome measures

  • Total Postoperative Analgesic Consumption in Morphine Milligram Equivalents (MME) [Time frame: From end of surgery through 8 weeks post-surgery.]
  • 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.]
  • Length of Hospital Stay [Time frame: From the day of surgery until hospital discharge (typically 2-7 days postoperatively)]
  • 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 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.]
Secondary outcome measures (1)
  • Incidence of Surgical Site Infections [Time frame: Within 8 weeks post-surgery.]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Double blind
Primary purpose
Treatment

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT07201987 · 2025p001993

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗