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

NCT ID: NCT07201987

Last Updated: 2025-10-01

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: PHASE2
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2026-01-31
• Study Completion Date: 2027-01-31

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

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.

Group Type: EXPERIMENTAL

Vancomycin (local, via calcium sulfate beads)

Intervention Type: 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.

Morphine (local, via calcium sulfate beads)

Intervention Type: 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)

Intervention Type: 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 (standard-of-care)

Patients will receive intraoperative placement of vancomycin-impregnated calcium sulfate beads for surgical site infection prophylaxis, without added analgesics.

Group Type: ACTIVE_COMPARATOR

Vancomycin (local, via calcium sulfate beads)

Intervention Type: 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.

Interventions

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.

Intervention Type: 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.

Intervention Type: 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.

Intervention Type: DRUG

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ganesh M. Shankar

OTHER

Sponsor Role: lead

Responsible Party

Ganesh M. Shankar

Principal Investigator

Responsibility Role: SPONSOR_INVESTIGATOR

Central Contacts

Ganesh Shankar, MD, PhD

Role: CONTACT

gshankar@mgh.harvard.edu

617-724-1099

Other Identifiers

2025p001993

Identifier Type: -

Identifier Source: org_study_id