Intraoperative Placement of Vancomycin-impregnated Calcium Sulfate Beads Conjugated With Analgesics to Improve Spine Surgery Outcomes
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 100
- 主要终点
- Total Postoperative Analgesic Consumption in Morphine Milligram Equivalents (MME)
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥ 18 years
- •Able to understand and provide consent in English
- •Undergoing elective lumbar spinal decompression and fusion surgery at one or two levels
排除标准
- •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
研究组 & 干预措施
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.
干预措施: Morphine (local, via calcium sulfate beads) (Drug)
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.
干预措施: Vancomycin (local, via calcium sulfate beads) (Drug)
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.
干预措施: Bupivacaine (local, via calcium sulfate beads) (Drug)
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.
干预措施: Vancomycin (local, via calcium sulfate beads) (Drug)
结局指标
主要结局
Total Postoperative Analgesic Consumption in Morphine Milligram Equivalents (MME)
时间窗: From end of surgery through 8 weeks post-surgery.
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
时间窗: Baseline (pre-surgery), 24-48 hours, 2-3 weeks, and 8 weeks post-surgery.
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
时间窗: From the day of surgery until hospital discharge (typically 2-7 days postoperatively)
Number of days from surgery to hospital discharge.
Change from Baseline in Functional Status as Measured by PROMIS Physical Function Short Form 10a
时间窗: Baseline (pre-surgery), 2-3 weeks, and 8 weeks post-surgery.
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.
Change from Baseline in Functional Status as Measured by Oswestry Disability Index (ODI)
时间窗: Baseline (pre-surgery), 2-3 weeks, and 8 weeks post-surgery.
Change in disability as reported by participants using the Oswestry Disability Index (ODI). Scores range from 0 to 100; higher scores indicate greater disability.
次要结局
- Incidence of Surgical Site Infections(Within 8 weeks post-surgery.)
研究者
Ganesh M. Shankar
Principal Investigator
Massachusetts General Hospital