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临床试验/NCT07262398
NCT07262398已完成4 期

Effect Of Unilateral Intra-thecal Prilocaine-Fentanyl Versus Bupivacaine-Fentanyl On Post-Operative Spontaneous Voiding Within The Context Of Ambulatory Anesthesia. A Prospective Randomized Double-Blind Controlled Study

Theodor Bilharz Research Institute1 个研究点 分布在 1 个国家目标入组 70 人开始时间: 2024年8月3日最近更新:
干预措施

试验速览

阶段
4 期
状态
已完成
入组人数
70
试验地点
1
主要终点
postoperative voiding

研究概览

简要总结

Background: In the context of day-case surgery, the optimal spinal anesthetic should give immediate and effective anesthesia for an appropriate period, followed by rapid regression of sensory and motor blocking, rapid bladder voiding, and little residual effects to allow for early ambulation and discharge. Although bupivacaine is safe and has a low rate of transient neurological symptoms (TNS), the prolonged sensory and motor block is a drawback for use in day-case spinal anesthesia. Similar to lidocaine, prilocaine is a local anesthetic with similar potency and duration of action and has been reported to have a lower incidence of TNS.

Objective: To determine which local anesthetic, Prilocaine with added fentanyl versus bupivacaine with added fentanyl, is better in the setting of fast-track anesthesia in patients undergoing unilateral inguinal hernia.

Material and methods: 70 Patients who were between 18-60 years old male patients, ASA grade I-II, BMI < 35, undergoing elective unilateral inguinal hernia, standard surgical technique (open anterior prosthetic inguinal hernioplasty) inguinal hernia diagnosis is confirmed by ultrasonography, free medical history of micturition disorder, procedure lasting less than 90 minutes, having provided written informed consent signed by the patient or guardian were included. Those patients were divided into two groups. Group Pr (Prilocaine 40mg + fentanyl 25μ) and group Bu (Bupivacaine 7.5mg + fentanyl 25mcg)

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Diagnostic
盲法
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

入排标准

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

入选标准

  • BMI < 35 kg/m
  • Absence of micturition disorder.
  • Patients scheduled for elective unilateral inguinal hernia with standard surgical technique (open anterior prosthetic inguinal hernioplasty) with previous ultrasonography confirmation of the diagnosis.

排除标准

  • Allergic to any drug being used in the study.
  • ASA III-IV.
  • Suffering from bulky inguinal/inguino-scrotal hernias.
  • Patients with infection at the injection site.
  • Non-cooperative patients.
  • Patients having sensory or motor deficit in lower extremities or history of micturition disorder, abnormal coagulation profile, history of alcohol or substance abuse.
  • contraindications or failure of spinal anesthesia and surgery lasting more than 90 minutes.

研究组 & 干预措施

prilocaine

Active Comparator

Prilocaine 40mg (2ml) + fentanyl 25mcg in unilateral spinal anesthesia

干预措施: Prilocaine (Drug)

Bupivacaine

Active Comparator

Bupivacaine 7.5mg (1.5ml) + fentanyl 25mcg in unilateral spinal anesthesia

干预措施: Bupivacain (Drug)

结局指标

主要结局

postoperative voiding

时间窗: first 2 hours postoperatively

time for the first spontaneous micturition

次要结局

  • peak level of spinal anesthesia(15 minutes)

研究者

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

Moshira sayed mohamed

professor of anesthesia

Theodor Bilharz Research Institute

研究点 (1)

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