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临床试验/NCT06577064
NCT06577064已完成不适用

Sacral Erector Spinae Block for Pilonidal Sinus Surgery: A Randomized Controlled Trial

Menoufia University2 个研究点 分布在 1 个国家目标入组 62 人开始时间: 2023年11月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
62
试验地点
2
主要终点
Pain score

研究概览

简要总结

The incidence of pilonidal sinus disease (PD) is estimated to be around 26/100,000 individuals mostly men.PD can cause the development of abscess or a draining sinus tract and that may lead to a loss of productive power and long-term morbidity.Different surgical technique approaches were proposed for treatment with different rates of success.

详细描述

Sacral erector spinae plane block was first described by Tulgar et al. To provide sensory blockade in the parasacral region in two cases who had pilonidal sinus surgeries. Since then, the block was used for multiple surgeries like anorecatal, hip surgery and parasacral reconstructive surgeries.After obtaining the ethical committee approval from Menoufia University. patients scheduled for pilonidal sinus surgery will be randomly allocated into one of two groups Patients will be randomized to a study group using a computer-generated random number table, and the allocation concealment will be performed using a sealed envelope technique.The sealed opaque envelopes will be kept locked in dedicated research safe and will be accessed by a research coordinator only when a patient consented for the study. The anesthetist will perform the intervention with the doses and concentration of drugs as per the protocol.

The patients and the follow up researcher will be blinded to the type of intervention used. The patient follow-up time will be scheduled intraoperatively PACU, 1 hour and 24hours postoperatively. The anesthetist who did the intervention will have no access to the reported documents or contact with the patient postoperatively.

For induction of anesthesia all patients will receive medication as per the facility protocol where propofol 1-2mg/Kg, fentanyl 2μg/Kg (actual BW), rocuronium 0.5 mg/kg will be used for induction and an endotracheal tube intubation will be inserted to secure the airway. After intubation and confirmation of endotracheal tube placement by auscultation and capnography, the patient will be turned into prone position.

Maintenance of anesthesia will be maintained by sevoflurane 1-1.2 MAC and rocuronium 0.1mg/kg guided by the TOF. All patients will receive multimodal analgesia in the form of paracetamol 1gm and parecoxib 40 mg (Pizer manufacturing Belgium). After exclusion of other causes of tachycardia and hypertension Morphine 2mg increments will be administrated to keep the heart rate or blood pressure within 20 percent of the patient's baseline parameters.

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 (Care Provider, Investigator)

入排标准

年龄范围
18 Years 至 60 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Age >18 years old
  • ASA physical status 1-3

排除标准

  • Opioid use within the previous 3 months
  • Deranged coagulation parameters
  • Patient refusal
  • Allergy to local anesthetic medication.
  • Preoperative neurological deficits

结局指标

主要结局

Pain score

时间窗: 24 hours

NRS scor for post operative pain scale from 0 to 100

次要结局

  • Lower limb motor affection(24 hours)
  • Adverse effects(24 hours)
  • Opioid consumption.(24 hours)

研究者

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

rabab Mohammad habeeb

Principal investigator

Menoufia University

研究点 (2)

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