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.

Study Overview

• Status: Not yet recruiting
• Conditions: Spine Surgery; Postoperative Pain Management
• Intervention / Treatment: Drug: Vancomycin (local, via calcium sulfate beads); Drug: Morphine (local, via calcium sulfate beads); Drug: Bupivacaine (local, via calcium sulfate beads)

• Study Type: Interventional
• Enrollment (Estimated): 100
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Ganesh Shankar, MD, PhD; Phone Number: 617-724-1099; Email: gshankar@mgh.harvard.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Vancomycin-impregnated calcium sulfate beads with morphine and bupivacaine; 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.	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.
Active Comparator: Vancomycin-impregnated calcium sulfate beads (standard-of-care); Patients will receive intraoperative placement of vancomycin-impregnated calcium sulfate beads for surgical site infection prophylaxis, without added analgesics.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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.

Secondary Outcome Measures

Outcome Measure	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.

Collaborators and Investigators

• Sponsor: Ganesh M. Shankar

Study record dates

Study Major Dates

• Study Start (Estimated): January 1, 2027
• Primary Completion (Estimated): January 1, 2028
• Study Completion (Estimated): January 1, 2028

Study Registration Dates

• First Submitted: September 8, 2025
• First Submitted That Met QC Criteria: September 23, 2025
• First Posted (Actual): October 1, 2025

Study Record Updates

• Last Update Posted (Actual): April 16, 2026
• Last Update Submitted That Met QC Criteria: April 14, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: Vancomycin; Analgesics; Postoperative pain management; Spine surgery; Hospital length of stay; Calcium sulfate beads
• Additional Relevant MeSH Terms: Peptides; Amino Acids, Peptides, and Proteins; Organic Chemicals; Heterocyclic Compounds; Heterocyclic Compounds, Fused-Ring; Carbohydrates; Alkaloids; Polycyclic Aromatic Hydrocarbons; Polycyclic Compounds; Anilides; Amides; Aniline Compounds; Amines; Heterocyclic Compounds, 4 or More Rings; Glycoconjugates; Glycopeptides; Morphinans; Opiate Alkaloids; Heterocyclic Compounds, Bridged-Ring; Phenanthrenes; Morphine Derivatives; Bupivacaine; Morphine; Vancomycin
• Other Study ID Numbers: 2025p001993

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: 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 Sharing Time Frame: 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.
• IPD Sharing Access Criteria: 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).
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No