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

NCT07201987 | Not Yet Recruiting Phase 2 FDA Drug

• 1 other identifier: 2025p001993
• Study Type: interventional
• Target: 100
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Spine Surgery; Postoperative Pain Management

Keywords

Spine surgery; Postoperative pain management; Calcium sulfate beads; Vancomycin; Analgesics; Hospital length of stay

Outcome Measures

Primary Outcomes (5)

• 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 Outcomes (1)

• Incidence of Surgical Site Infections

  Within 8 weeks post-surgery.

Study Arms (2)

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.

Drug: Vancomycin (local, via calcium sulfate beads); Drug: Morphine (local, via calcium sulfate beads); Drug: Bupivacaine (local, via calcium sulfate beads)

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.

Drug: Vancomycin (local, via calcium sulfate beads)

Interventions

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.

Vancomycin-impregnated calcium sulfate beads (standard-of-care); Vancomycin-impregnated calcium sulfate beads with morphine and bupivacaine

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.

Vancomycin-impregnated calcium sulfate beads with morphine and bupivacaine

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.

Vancomycin-impregnated calcium sulfate beads with morphine and bupivacaine

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥ 18 years
• Able to understand and provide consent in English
• Undergoing elective lumbar spinal decompression and fusion surgery at one or two levels

You may not qualify if:

• 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

Sponsors & Collaborators

• Ganesh M. Shankar: lead

MeSH Terms

Interventions

Vancomycin; Morphine; Bupivacaine

Intervention Hierarchy (Ancestors)

Glycopeptides; Glycoconjugates; Carbohydrates; Peptides; Amino Acids, Peptides, and Proteins; Morphine Derivatives; Morphinans; Opiate Alkaloids; Alkaloids; Heterocyclic Compounds; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Phenanthrenes; Polycyclic Aromatic Hydrocarbons; Polycyclic Compounds; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Central Study Contacts

Ganesh Shankar, MD, PhD

CONTACT

617-724-1099; gshankar@mgh.harvard.edu

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: September 8, 2025
• First Posted: October 1, 2025
• Study Start (Estimated): January 1, 2027
• Primary Completion (Estimated): January 1, 2028
• Study Completion (Estimated): January 1, 2028
• Last Updated: April 16, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR
• 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.
• 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).