跳至主要内容
临床试验/NCT04336111
NCT04336111招募中不适用

Ultrasound Guided Bilateral Retrolaminar Block as Analgesia for Adolescent Idiopathic Scoliosis Correction

Tanta University1 个研究点 分布在 1 个国家目标入组 44 人开始时间: 2023年12月30日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
44
试验地点
1
主要终点
time to first analgesic request

研究概览

简要总结

Scoliosis is a structural, tridimensional deformity of the spine. Characterized by lateral curvature and rotation of the vertebrae with functional limitations and cosmetic problems, idiopathic scoliosis, which accounts for 75% to 80% of all scoliosis, is the most common of all types. (1, 2) Surgical treatment is an effective way to correct severe spine deformity when the deformity progressively worsens and cannot be positively corrected by brace treatment. Spinal correction surgery is one of the most invasive surgical procedures and usually results in moderate to severe levels of postoperative pain. (3) Severe pain may induce implant complications such as construct dislodgement, broken instrumentation, and implant loosening which requires additional revision procedures These conditions adversely affect postoperative outcomes.(4) In the past several years, pain has become an important indicator for evaluating indicators of outcome and quality of life after surgery. Effective analgesia after surgery could improve patients' prognosis.(5) The retrolaminar block is a recently described ultrasound-guided technique in which local anesthetics is injected into the fascial plane between the posterior surface of the thoracic lamina and the overlying transverso-spinalis muscles. (2) The available evidence indicates that retrolaminar block is effective in reducing opioid requirements and improving the pain experience in a wide range of clinical settings. They are best employed as part of multimodal analgesia with other systemic analgesics

详细描述

-Preoperative: Evaluation of patients will be carried out through proper history taking, clinical examination and routine laboratory investigation and patients will be trained to use the Numerical Rating Scale (NRS 0= no pain, 10= intolerable pain) used for evaluation of pain intensity.

The patient is allowed to fast for 8 hours for solids and 2h for clear fluid. Before the study, all patients will be interviewed and will be briefed on the wake-up test procedure. They will be informed that they will be asked to open their eyes, move their fingers (hold the anesthesiologist's hand), move their toes, and finally, to remember a given color.

-Intraoperative: On arrival to operating roome, a 20 G peripheral IV cannula will be inserted. Electrocardiogram (ECG), noninvasive mean arterial blood pressure (MAP) and peripheral oxygen saturation will be attached and baseline data will be monitored and documented. Sedation will be given intravenously in the form of midazolam 0.02 mg/kg and IV fliud according to calculation of deficit and maintaince calculation.

After preoxygenation, anesthesia with IV propofol 2 mg/ kg and fentanyl 2 µg/kg will be administered for analgesia and cisatracurium 0.5 mg/ kg will be given intravenously to facilitate endotracheal intubation.

Central venous catheter will be inserted and attached for monitoring of CVP. Also, enotropy will be connected on the patientꞌs forehead and maintained between 40-60.

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
Single (Outcomes Assessor)

入排标准

年龄范围
10 Years 至 65 Years(Child, Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients with idiopathic adolescent scoliosis undergoing surgical correction

排除标准

  • Bleeding disorders (coagulopathy).
  • Mental dysfunction.
  • History of allergy to local anesthetics.

结局指标

主要结局

time to first analgesic request

时间窗: within 24 hrs postoperative

time to first analgesic request

次要结局

  • postoperative morphine consumption(within 24 hrs postoperative)
  • intraoperative fentanyl consumption(intraoperative)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Amany Faheem

Principal Investigator

Tanta University

研究点 (1)

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