Fluoroscopy-Guided Retrolaminar Block Versus Local Wound Infiltration for Post Lumbar Discectomy Analgesia: A Double-Blinded, Randomized Trial
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 130
- 试验地点
- 1
- 主要终点
- Number of patients who required rescue analgesia
研究概览
简要总结
Lumbar discectomy surgeries are often the last option for patients with disc herniation who do not improve with conservative treatments. However, these procedures can lead to significant perioperative pain that may become chronic without effective management. While intravenous opioids are commonly used for pain control, they can complicate recovery and pose risks like dependence. In contrast, regional anesthetic techniques offer advantages such as quicker recovery, better postoperative pain relief, and reduced opioid use, which can lead to shorter hospital stays. Our study aims to compare the effectiveness of the retrolaminar block with local wound infiltration for pain management following posterior lumbar discectomy surgeries, potentially improving patient outcomes.
详细描述
Lumbar discectomy surgeries are the last resort for disc herniation patients not responding to conservative treatment. However, these surgeries are associated with annoying perioperative pain that could be severe and progress to chronic pain if not managed properly. There is no consensus regarding the best approach for postoperative pain management following spine surgeries. Intravenous opioids are still the primary agents used for perioperative pain control, which can complicate the postoperative recovery with the associated side effects and the risk of opioid dependence. Regional anesthetic techniques for spine surgeries allow rapid recovery, prolonged postoperative analgesia, and less opioid consumption, which decreases hospital stays. The current study will compare the analgesic efficacy of the retrolaminar block to the local wound infiltration following posterior lumbar discectomy surgeries.
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
- 21 Years 至 64 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Elective surgical decompression of single-level herniated lumbar disc.
排除标准
- •Opioid-dependent patients.
- •Known hypersensitivity to bupivacaine.
- •Diabetic patients.
- •Uncooperative patient or with altered mental status.
- •Previous spine surgery.
研究组 & 干预措施
Local Infiltration group
The patient will receive local wound infiltration following the completion of the surgical steps with the patient in the prone position using a local anesthetic solution, tailored to the specific conditions surrounding the incision site.
干预措施: Local wound infiltration (Procedure)
Retrolaminar block group
After confirming the correct position using imaging with a C-Arm device, the patient will receive a retrolaminar block on both sides at the level of the operated disc.
干预措施: Retrolaminar plane block (Procedure)
结局指标
主要结局
Number of patients who required rescue analgesia
时间窗: The first 24 hours postoperative.
The percentage of patients who required rescue analgesia within the first 24 hours.
The time to first rescue analgesia
时间窗: The first 24 hours postoperative.
The time to first rescue analgesic request within the first 24 hours postoperative.
Number of patients who required rescue analgesia
时间窗: The first 24 hours postoperative.
The percentage of patients who required rescue analgesia within the first 24 hours.
Total amount of opioid consumption
时间窗: The first 24 hours postoperative.
The total opioid consumption within the first 24 hours postoperative.
次要结局
- Duration of the surgical intervention.(The first 2 hours.)
- Total amount of opioid consumption(The first 24 hours postoperative.)
- The Numerical Pain Rating Scale(The first 24 hours postoperative.)
- Patient satisfaction (quality of life questionnaire)(At the end of the first 24 hours postoperative.)