Comparison of the Ultrasound-guided Erector Spinae Plane Block and Wound Infiltration for Postoperative Pain Management in Lumbar Disc Surgery
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 46
- 试验地点
- 1
- 主要终点
- US-guided ESPB and WI on postoperative pain
研究概览
简要总结
This study included 46 patients who underwent lumbar disc herniation surgery under general anesthesia. After the operation, US-guided ESPB was performed on Group E, and WI was performed on Group W. Postoperative pain was assessed, and the time to first analgesic requirement, total analgesic amount in 24 hours, and side effects were recorded. IBM SPSS Statistics 22 was used for statistical analyses.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Double (Participant, Investigator)
盲法说明
The study was initially conducted without prior registration, but a registration number is now required for publication
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Anesthesiologists (ASA) physical status I-II
排除标准
- •Patients with recurrent lumbar disc herniation,
- •Obesity (body mass index >35 kg/m2),
- •Infection in the surgical site,
- •Known local anesthetic drug allergy,
- •Chronic pain, and coagulation disorders were excluded.
研究组 & 干预措施
erector spinae plane block
At the end of the surgery, while the patient was still intubated and in the prone position, the linear probe of a Samsung HM70 EVO ultrasound device was placed sagittally, approximately 2-3 cm lateral to the spinal cord. After identifying the erector spinae muscle and transverse processes, a 22-G, 10-mm block needle (Braun Stimuplex Ultra 360, Germany) was advanced posterior to the transverse process after reaching the bone structure. The location of the needle tip was then confirmed, 0.25% bupivacaine (20mL) was injected intermittently, and separation of the erector spinae muscle from the transverse process was observed. The procedure was applied bilaterally (22 patients)
干预措施: erector spinae plane block(ESPB) (Other)
wound infiltration
In Group W, a dose of 0.5% bupivacaine (20 ml) was injected for wound infiltration into the surgery site. (24 patients)
干预措施: erector spinae plane block(ESPB) (Other)
结局指标
主要结局
US-guided ESPB and WI on postoperative pain
时间窗: postoperative 1 hour, 3 hours, 12 hours, and 24 hours
Postoperative pain assessment was conducted in the recovery unit using the Numeric Rating Scale (NRS) with a scale of 0 (no pain) to 10 (worst pain imaginable). Standard postoperative intravenous analgesia included 75 mg of diclofenac sodium administered every 8 hours. In cases where NRS was ≥4, rescue analgesia was provided with 100 mg of intravenous tramadol. Anesthesia duration, surgical duration, NRS scores at postoperative 1 hour, 3 hours, 12 hours, and 24 hours, time to first analgesic, and total analgesic requirement in the first 24 hours were recorded. All side effects (hypotension, bradycardia, etc.) were documented.
次要结局
未报告次要终点
研究者
İrem DURMUS
Principal Investigator
Dr. Lutfi Kirdar Kartal Training and Research Hospital