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临床试验/NCT05999253
NCT05999253已完成不适用

Comparison of the Effects of Modified Thoracolumbar Interfacial Plane (mTLIP) Block and Erector Spina Plane Block on Postoperative Pain and Opioid Analgesic Consumption in Patients Undergoing Lumbar Discectomy for Lumbar Disc Herniation

Saglik Bilimleri Universitesi Gazi Yasargil Training and Research Hospital1 个研究点 分布在 1 个国家目标入组 96 人开始时间: 2023年10月3日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
96
试验地点
1
主要终点
Visual Analogue Scale (VAS)

研究概览

简要总结

Patients who will undergo herniated disc surgery have serious pain after surgery. In order to minimise this pain and to ensure that they recover more quickly and use less morphine-derived painkillers, we aim to apply two types of painkiller injections before surgery. For this purpose, it is planned to apply painkiller injections on both sides of the level of the herniated disc with sedation before the operation. Afterwards, herniated disc surgery will be performed under general anaesthesia.

详细描述

Modified thoracolumbar plane block (mTLIP): under ultrasound-guided, the lateral compartment of the longissimus muscle and iliocostal muscle muscles are imagined and the block needle is placed in the interfascial plane of these two muscles and local anesthesic solution is appliced.

  • 20 ml of 0.25% bupivacaine will be used on each side (total of 40 ml of 0.25% bupivacaine will be used)
  • to be administered only approximately 20-30 minutes before the onset of anaesthesia.
  • only once in the preoperative block room approximately 20-30 minutes before induction of anaesthesia
  • plane block applications will be performed by anaesthesiologists with at least 5 years of experience
  • patients' intraoperative fentanyl consumption, agitation-sedation scores on awakening from anaesthesia, tramadol consumption in the postoperative 24 hours, postoperative VAS pain scores, and side effects such as postoperative nausea-vomiting will be evaluated.
  • plane blocks will be applied under ultrasound guidance.
  • plane block applications will be performed by anaesthesiologists with at least 5 years of experience
  • Postoperative evaluations of patients will be performed face to face. Patients will be routinely administered 1 g paracetamol intravenously at 8 hour intervals in the postoperative period. 100 mg tramadol intravenously will be administered if their pain is above VAS 4 despite this.
  • This study was followed up in the neurosurgery unit of SBU Gazi Yasargil Training and Research Hospital.
  • Patients were sedated with 1 mg midazolam and 50 mcg fentanyl intravenously in the preoperative preparation room in the operating room and 20 ml of 0.25% bupivacaine was administered bilaterally on each side under ultrasound guidance. After the block application, the patient was taken to the operating room and standard general anaesthesia was applied.

Patients will be monitored for pain and side effects at the neurosurgery unit , 1st hour, 2nd hour, 4th hour, 8th hour and 24th hour in the postoperative period.

  • Both plan blocks are applied for analgesia in the postoperative period and aim to reduce opioid consumption in the postoperative period.

Erector spinae plane block (ESP): After determining the vertebral spinal process and trapezius, rhomboid major and erector spinae muscles with ultrasound guidance, the block needle is advanced in the cranio-caudal direction with an in plane approach and local anaesthetic solution is applied to the plane between the erector spinae muscle and the transverse process when the needle rests on the transverse process.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 70 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients between 18-70 years of age, ASA I-III, scheduled for Lumbar Disc Herniation operation under general anaesthesia.

排除标准

  • ASA >III body mass index (BMI) > 35 kg/m2 known allergy to local anaesthetics presence of preoperative chronic pain presence of coagulopathy those who are unable to give written consent non-voluntary patients

结局指标

主要结局

Visual Analogue Scale (VAS)

时间窗: assessed at postoperative 1st, 2nd, 4th, 8th and 24th hours

* The visual analog scale (VAS) is a validated, subjective measure for acute and chronic pain. Scores are recorded by making a handwritten mark on a 10-cm line that represents a continuum between "no pain" and "worst pain." * Low back pain and leg pain as an extension of the traveling nerve assessed using visual pain scores (VAS) will be evaluated

次要结局

  • heart rate monitoring(before the start of surgery, at 5 minutes, 10 minutes, 15 minutes, 20 minutes, 25 minutes, 30 minutes, 40 minutes, 50th minutes, 60 minutes after the start of surgery)
  • Sedation- agitation level(After extubation])
  • Amount of tramadol used postoperatively(during the postoperative 24 hour])
  • patient satisfaction assessmen(at the end of 24 hours postoperatively)
  • Nausea-vomiting(postoperative 1st, 2nd, 4th, 8th and 24th hours)
  • Systolic, diastolic and mean arterial pressure monitoring(before the start of surgery, at 5 minutes, 10 minutes, 15 minutes, 20 minutes, 25 minutes, 30 minutes, 40 minutes, 50th minutes, 60 minutes after the start of surgery)
  • amount of fentanyl consumed during the operation(during surgery)
  • Surgery duration(at the end of surgery])
  • Anesthesia duration(at the end of anaesthesia])

研究者

发起方
Saglik Bilimleri Universitesi Gazi Yasargil Training and Research Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

Fatma Acil

Anesthesiology and Reanimation Spesialist

Saglik Bilimleri Universitesi Gazi Yasargil Training and Research Hospital

研究点 (1)

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