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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:
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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Vancomycin-impregnated calcium sulfate beads with morphine and bupivacaine | Experimental | 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 | Patients will receive intraoperative placement of vancomycin-impregnated calcium sulfate beads for surgical site infection prophylaxis, without added analgesics. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Total Postoperative Analgesic Consumption in Morphine Milligram Equivalents (MME) | Cumulative dose of opioids and non-opioid analgesics used postoperatively, converted to morphine milligram equivalents. | 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 | 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). | Baseline (pre-surgery), 24-48 hours, 2-3 weeks, and 8 weeks post-surgery. |
| Length of Hospital Stay | Number of days from surgery to hospital discharge. | 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 | 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. | Baseline (pre-surgery), 2-3 weeks, and 8 weeks post-surgery. |
| Change from Baseline in Functional Status as Measured by Oswestry Disability Index (ODI) | Change in disability as reported by participants using the Oswestry Disability Index (ODI). Scores range from 0 to 100; higher scores indicate greater disability. | Baseline (pre-surgery), 2-3 weeks, and 8 weeks post-surgery. |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of Surgical Site Infections | Number of participants with a postoperative surgical site infection, defined by CDC criteria. | Within 8 weeks post-surgery. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Ganesh Shankar, MD, PhD | Contact | 617-724-1099 | gshankar@mgh.harvard.edu |
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De-identified individual participant data (IPD) underlying the primary and secondary outcome results (including demographics, pain scores, analgesic consumption, hospital length of stay, functional outcomes, and adverse event data) will be shared. No data containing direct identifiers will be provided.
IPD and supporting documents will be made available beginning 6 months after publication of the primary study results and will remain available for 5 years.
Access will be granted to qualified researchers affiliated with academic or healthcare institutions who provide a methodologically sound proposal for secondary analyses related to spine surgery outcomes, pain management, or infection prevention. Proposals will be reviewed by the Principal Investigator and research team. Upon approval, data will be shared via a secure, HIPAA-compliant institutional data-sharing platform. Requests should be directed to Ganesh Shankar (gshankar@mgh.harvard.edu).
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| 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. |
|
| ID | Term |
|---|---|
| D014640 | Vancomycin |
| D009020 | Morphine |
| D002045 | Bupivacaine |
| ID | Term |
|---|---|
| D006020 | Glycopeptides |
| D006001 | Glycoconjugates |
| D002241 | Carbohydrates |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| D009022 | Morphine Derivatives |
| D009019 | Morphinans |
| D053610 | Opiate Alkaloids |
| D000470 | Alkaloids |
| D006571 | Heterocyclic Compounds |
| D006572 | Heterocyclic Compounds, Bridged-Ring |
| D006576 | Heterocyclic Compounds, 4 or More Rings |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D010616 | Phenanthrenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D011083 | Polycyclic Compounds |
| D000813 | Anilides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000814 | Aniline Compounds |
| D000588 | Amines |
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