A Comparison of Epidural and Intravenous Patient-Controlled Analgesia Following Lumbar Spinal Fusion Surgery: A Prospective Randomized Study
试验速览
- 阶段
- 4 期
- 状态
- 终止
- 入组人数
- 46
- 试验地点
- 2
- 主要终点
- Visual Analog Pain Score (VAS)
研究概览
简要总结
Postoperative analgesia following spine surgery is difficult to manage. Current treatment modalities rely heavily on opioid analgesics with all of the inherent limitations and side effects. While current best practice focuses on a 'multimodal approach' (i.e. using multiple different drugs and techniques to control pain after surgery), there is no consensus regarding which components of this multimodal therapy provide optimal analgesia. This prospective randomized study will enroll patients undergoing elective Lumbar Spinal Fusion Surgery at Zale Lipshy University Hospital. The primary objective is to determine the comparative efficacy of epidural analgesia, as compared with intravenous (IV) patient-controlled analgesia (PCA), on post-operative analgesia.
详细描述
Study Design: Prospective study of 58 subjects undergoing elective Lumbar Spinal Fusion (1-3 levels- posterior approach) at UTSW Zale Lipshy University Hospital with:
- Continuous Lumbar Epidural Analgesia (Patient-Controlled Epidural Analgesia- PCEA groups)
- Intravenous Patient-Controlled Analgesia (IV PCA)
Study Interventions - The intervention to be evaluated in this study is epidural analgesia using an infusion of 0.0625% bupivacaine plus fentanyl 2mcg/ml. The epidural infusion will be continued until it is appropriate to transition the patient to a regimen of oral pain medications. Duration of epidural catheter will be 72 hours a postoperatively.
For subjects in the IV PCA group, the intervention will include post-operative IV PCA with Hydromorphone.
Epidural catheters will be placed by the spine surgeon under direct visualization intra-operatively prior to closing the surgical incision. Intra-operative epidural catheter placement by the spine surgeon will typically be done at the upper end of the dural exposure/laminectomy.
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
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult subjects aged 18 years or older
- •Scheduled for elective posterior lumbar spinal fusion surgery between 1 and 3 levels
排除标准
- •Baseline cognitive deficits sufficient to make objective pain self-assessments unreliable in the estimation of the Study Investigators.
- •Immunocompromised subject
- •Coagulopathy
- •Severe liver and renal dysfunction
- •Preoperative neurological deficits
- •The dura damage during surgery
- •Inability to follow directions or comprehend the English language.
- •Females who are pregnant as determined by positive pregnancy test on or before the day of surgery.
- •Prisoners.
- •Patient refusal to provide informed consent.
- •Allergy to amide local anesthetics (lidocaine, bupivacaine, ropivacaine) or opioid (fentanyl) allergy if patient assigned epidural analgesia.
- •Hydromorphone allergy if patient assigned IV PCA
研究组 & 干预措施
Patient-Controlled Epidural Analgesia
Bupivacaine and fentanyl infusion via Continuous Lumbar Epidural Analgesia during postoperative 72 hours
干预措施: Bupivacaine (Drug)
Patient-Controlled Epidural Analgesia
Bupivacaine and fentanyl infusion via Continuous Lumbar Epidural Analgesia during postoperative 72 hours
干预措施: Fentanyl (Drug)
Intravenous patient-controlled analgesia
Postoperative intravenous patient-controlled analgesia (IV PCA) with Hydromorphone
干预措施: Hydromorphone (Drug)
结局指标
主要结局
Visual Analog Pain Score (VAS)
时间窗: VAS score at postoperative 24 hours
Postoperative Visual Analog Pain Score following lumbar fusion surgery. VAS on the scale 0 to 100 (0= no pain, 100= worst pain).
次要结局
未报告次要终点
研究者
Enas Kandil
ASSOC PROFESSOR - Anesthesiology & Pain Mgmt
University of Texas Southwestern Medical Center