Comparison of Perineural Dexamethasone Versus Dexmedetomidine as Adjuvants to Erector Spinae Plane Block in Lumbar Spine Surgery: A Randomized, Double-blind, Controlled Trial
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 发起方
- 入组人数
- 150
- 试验地点
- 1
- 主要终点
- Total opioid Consuption
研究概览
简要总结
This clinical study aims to determine which of two medications-dexamethasone or dexmedetomidine-works better and is safer when used together with a local anesthetic (ropivacaine) in a type of nerve block called the erector spinae plane block (ESPB). This block helps reduce pain after lumbar spine surgery.
详细描述
All participants will receive general anesthesia for surgery and, in addition, a nerve block on both sides of the lower back. The nerve block will be done with ultrasound guidance and will include ropivacaine plus either dexamethasone or dexmedetomidine. Patients will be randomly assigned to one of these two groups, and neither the patient nor the doctors checking pain after surgery will know which medication was used.
The main goal is to see how much opioid pain medicine patients need during the first 24 and 48 hours after surgery. Other things we will look at include how strong the pain is, how soon pain relief is necessary, if there are any side effects like nausea or low blood pressure, and if there are any complications related to the block.
This study will help doctors choose the best option to manage pain after spine surgery while reducing the need for opioids and their side effects.
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
- Quadruple (Participant, Care Provider, Investigator, 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
- •Adults aged 18 to N/A (no limit)
- •Scheduled for elective lumbar spine surgery (e.g., decompression or fusion) via posterior approach
- •American Society of Anesthesiologists (ASA) physical status I-III
- •Body weight ≥ 50 kg
- •Ability to provide written informed consent
- •Expected postoperative hospitalization of at least 48 hours
排除标准
- •Known allergy or contraindication to ropivacaine, dexamethasone, or dexmedetomidine
- •Infection at or near the site of block placement
- •Coagulation disorders or current use of anticoagulant therapy (not discontinued per guidelines)
- •Chronic opioid use or opioid dependence
- •Neurological or psychiatric disorders interfering with pain assessment
- •Diabetes mellitus with poorly controlled glycemia (e.g., HbA1c > 8%)
- •Severe hepatic or renal dysfunction
- •Body mass index (BMI) > 40 kg/m²
- •Pregnancy or breastfeeding
- •Refusal or inability to cooperate with the study protocol
研究组 & 干预措施
Control group
Bilateral ESPB (2 x 20ml 0.2% ropivacaine with 1ml 0.9% NaCl)
干预措施: 0.9%NaCl (Drug)
Dexamethasone group
Bilateral ESPB (2 x 20ml 0.2% ropivacaine with 2mg dexamethasone)
干预措施: Dexamethasone 4mg (Drug)
Dexmedetomidine group
Bilateral ESPB (2 x 20ml 0.2% ropivacaine with 25ug dexmedetomidine)
干预措施: Dexmedetomidine (Drug)
结局指标
主要结局
Total opioid Consuption
时间窗: 48 hours after surgery
Cumulative opioid consumption during the first 24 and 48 hours after surgery, converted to morphine milligram equivalents (MME)
次要结局
- NRS(48 hours after surgery)
- Nerve injury(48 hours after surgery)
- adverce effects(48 hours after surgery)
- Time to first rescue analgesia(48 hours after surgery)
- blood glucose(48 hours after surgery)
- NLR - Neutrophil-to-Lymphocyte Ratio(48 hours after surgery)
- PLR - Platelet-to-Lymphocyte Ratio(48 hours after surgery)