Status:
NOT_YET_RECRUITING
Intraoperative Placement of Vancomycin-impregnated Calcium Sulfate Beads Conjugated With Analgesics to Improve Spine Surgery Outcomes
Lead Sponsor:
Ganesh M. Shankar
Conditions:
Spine Surgery
Postoperative Pain Management
Eligibility:
All Genders
18+ years
Phase:
PHASE2
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 st...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
January 1 2026
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 1 2027
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT07201987
Start Date
January 1 2026
End Date
January 1 2027
Last Update
October 1 2025
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