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.
Age ≥ 18 years
Able to understand and provide consent in English
Undergoing elective lumbar spinal decompression and fusion surgery at one or two levels
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).
Parallel
Vancomycin (local, via calcium sulfate beads)
DrugPatients 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)
DrugPatients 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)
DrugPatients 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.
Total Postoperative Analgesic Consumption in Morphine Milligram Equivalents (MME)
Cumulative dose of opioids and non-opioid analgesics used postoperatively, converted to morphine milligram equivalents.
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).
Length of Hospital Stay
Number of days from surgery to hospital discharge.
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.
Incidence of Surgical Site Infections
Number of participants with a postoperative surgical site infection, defined by CDC criteria.
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Ganesh M. Shankar
Lead sponsor
Massachusetts General Hospital
Sponsor institution
This trial is not recruiting at the moment. You can still explore other options:
