Comparative Effectiveness of Multi-modal Pain Management Versus Standard Intra- and Post-operative Analgesia: Randomized Controlled Clinical Trial to Reduce Post-operative Pain and Opioid Use Among Patients Undergoing Lumbar Spine Surgery
试验速览
- 阶段
- 早期 1 期
- 状态
- 已完成
- 入组人数
- 49
- 试验地点
- 1
- 主要终点
- Number of participants undergoing lumbar spine surgery with complete follow-up
研究概览
简要总结
Patients presenting for lumbar spine surgery experience pain related to their spine condition. Following surgery, these patients also experience surgical pain resulting from disruption of skin, muscle tissue, vertebrae, intervertebral discs, and facet joints. This pain is often treated with opioid medications - with roughly 40% of patient experiencing sub-optimal pain management. Adequate pain control has become a top priority among professional societies, healthcare systems, and accrediting agencies. The current proposal will provide this critical evidence of feasibility and acceptability of a multi-modal pain management plan for patients undergoing lumbar spine surgery. Additionally, this study will provide critical preliminary data to compare the effectiveness of protocol-driven multi-modal pain management to control post-operative pain, reduce opioid medication use, and improve physical activity, sleep, and health.
详细描述
Patients presenting for lumbar spine surgery experience pain related to their spine condition. Following surgery, these patients also experience surgical pain resulting from disruption of skin, muscle tissue, vertebrae, intervertebral discs, and facet joints. Proper pain management is necessary to reduce pain-related and medication side effects and to promote rehabilitation. This pain is often treated with opioid medications - with roughly 40% of patient experiencing sub-optimal pain management. Adequate pain control has become a top priority among professional societies, healthcare systems, and accrediting agencies.
Multi-modal pain management strategies have been proposed to (1) control pre-operative pain related to spine pathology; (2) employ non-opioid medication peri-operatively to pre-empt post-operative surgical pain; and (3) monitor and control pain intensity before and after surgery. There is a demonstrated lack of evidence regarding optimal post-operative protocols and pathways. The investigators have planned a randomized clinical trial to compare the effectiveness of two methods of peri-operative pain management to reduce post-operative pain and opioid use among patients undergoing lumbar spine surgery.
Prior to submission to National Institutes of Health (NIH), Agency for Healthcare Research and Quality (AHRQ), or Patient Centered Outcomes Research Institute (PCORI), it is necessary to demonstrate the feasibility and acceptability of the trial protocol. The current proposal will provide this critical evidence of feasibility and acceptability of a multi-modal pain management plan for patients undergoing lumbar spine surgery. Additionally, this study will provide critical preliminary data to compare the effectiveness of protocol-driven multi-modal pain management to control post-operative pain, reduce opioid medication use, and improve physical activity, sleep, and health.
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 (Care Provider, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Eligible participants will be English-speaking adults who are presenting to a spine surgeon (orthopaedic or neurosurgeon) for surgical treatment of a lumbar degenerative condition (spinal stenosis, spondylosis with or without myelopathy, and degenerative spondylolisthesis) using laminectomy with or without arthrodesis (i.e. fusion).
排除标准
- •A microsurgical technique as the primary procedure, such as an isolated laminotomy or microdiscectomy.
- •Spinal deformity as the primary indication for surgery.
- •Spine surgery secondary to pseudarthrosis, trauma, infection, or tumor.
- •Back and/or lower extremity pain < 3 months indicating no history of sub-acute or chronic pain.
- •History of neurological disorder or disease, resulting in moderate to severe movement dysfunction.
- •Presence of schizophrenia or other psychotic disorder.
- •Patient refusal to participate.
- •Known allergic reactions to any of the study medications
- •Surgery under a workman's compensation claim.
- •Not able to return to clinic for standard follow-up visits with surgeon.
- •Unable to provide a stable address and access to a telephone.
研究组 & 干预措施
Standard analgesia use
A strategy to manage pain in the peri-operative period that is in common clinical use.
干预措施: Standard analgesia use [Oxygen] (Drug)
Standard analgesia use
A strategy to manage pain in the peri-operative period that is in common clinical use.
干预措施: Standard analgesia use [Hydromorphone] (Drug)
Standard analgesia use
A strategy to manage pain in the peri-operative period that is in common clinical use.
干预措施: Standard analgesia use [Volatile Anesthesia] (Drug)
Standard analgesia use
A strategy to manage pain in the peri-operative period that is in common clinical use.
干预措施: Standard analgesia use [Fentanyl] (Drug)
Multi-modal pain management
A strategy to manage pain in the peri-operative period that is in common clinical use that is designed to reduce the need for post-operative opioid medication.
干预措施: Multi-modal pain management [Acetaminophen + Gabapentin] (Drug)
Multi-modal pain management
A strategy to manage pain in the peri-operative period that is in common clinical use that is designed to reduce the need for post-operative opioid medication.
干预措施: Multi-modal pain management [Fentanyl] (Drug)
Multi-modal pain management
A strategy to manage pain in the peri-operative period that is in common clinical use that is designed to reduce the need for post-operative opioid medication.
干预措施: Multi-modal pain management [Intravenous Ketamine] (Drug)
Multi-modal pain management
A strategy to manage pain in the peri-operative period that is in common clinical use that is designed to reduce the need for post-operative opioid medication.
干预措施: Multi-modal pain management [Valium + Gabapentin] (Drug)
结局指标
主要结局
Number of participants undergoing lumbar spine surgery with complete follow-up
时间窗: 52 week
Number of participants undergoing lumbar spine surgery with complete follow-up
次要结局
- PROMIS Anxiety(at 6 and 12 weeks)
- Patient controlled analgesia (PCA) pump use(during surgical hospitalization, up to 12 weeks)
- Opioid medication use(up to 90 days)
- Patient Reported Outcomes Measurement Information System (PROMIS) Pain(at 6 and 12 weeks)
- PROMIS Physical Function(at 6 and 12 weeks)
- PROMIS Fatigue(at 6 and 12 weeks)
- PROMIS Depression(at 6 and 12 weeks)
- PROMIS Sleep Disturbance(at 6 and 12 weeks)
- PROMIS Satisfaction with Social Roles(at 6 and 12 weeks)
- Health status (Medical Outcome Study Short Form 12, version 2)(at 6 and 12 weeks)
- Oswestry Disability Index (ODI)(at 6 and 12 weeks)