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临床试验/NCT02813382
NCT02813382已完成不适用

Intrathecal 60mg Prilocaine, Hyperbaric 40mg 9-chloroprocaine and 10.5mg Bupivacaine Each With Added Sufentanil (2µg) for Elective Ambulatory Umbilical and Unilateral Inguinal Herniorrhaphy

AZ St.-Dimpna Geel0 个研究点目标入组 101 人开始时间: 2015年8月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
101
主要终点
Time to void

研究概览

简要总结

Considering fast-track principles, an ideal spinal anesthetic should have minimal complications and above all fast recovery so reducing in-hospital stay.

Between 1/8/2015 and 1/1/2016, a total of 101 patients attending the surgeon's practice with an umbilical or unilateral inguinal hernia and no contra-indications for surgery were included in this study. Patients were given 10.5mg bupivacaine (B-group), 40mg hyperbaric 2-chloroprocaïne (C-group) or 60mg prilocaïne (P-group), each with added sufentanil (2µg). Motor block was assessed using the Bromage scale. Sensory block was measured by determining the peak level dermatome. Intraoperative hemodynamic parameters were listed. Resolution of sensory and motor block, time to void and home readiness were defined as clinical endpoints.

详细描述

Open inguinal and umbilical hernia repair are two of the most performed interventions in day-care surgery. Fast-track surgery implies a swift and effective form of anesthesia which is easy to carry out, has few side-effects and is quickly reversed.

Spinal anesthesia has proven to be a safe method to ensure adequate analgesia for patients undergoing elective open abdominal wall surgery as the need and side-effects of general anesthesia are avoided. During many years, a variety of intrathecal products alongside a plethora of adjuvants have been evaluated.

Three different types of spinal anesthetic products already used in routine care were compared: hyperbaric 9-chloroprocaïne (Ampres®, Nordic Pharma), bupivacaine (Marcaine®, AstraZeneca) and prilocaine (Tachipri®, Nordic Pharma).

Between 1/8/2015 and 1/1/2016, a total of 101 patients attending the surgeon's practice with an umbilical or unilateral inguinal hernia and no contra-indications for surgery were included in this study. Local ethical committee approval (EC0G099 - AZ Sint Dimpna, Geel, Belgium) and individual written informed consent was obtained. Surgical procedures were performed by 2 surgeons (TL and TG). The hernia was diagnosed clinically and/or by ultrasonography. Patients were preoperatively informed about the details concerning surgery and anesthesiology.

All patients were hospitalized on the day of surgery following standard preoperative instructions. Spinal anesthesia was performed by 6 different anesthesiologists. Patients with contraindications for spinal anesthesia were excluded: INR (international normalized ratio) > 1.2, thrombocytopenia (<75.000/µl), symptomatic neurological disease and proven allergy for local anesthetic. All patients received 1g of cefazolin (following standard guidelines for antibiotic prophylaxis of surgical wounds).

研究设计

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

入排标准

性别
All
接受健康志愿者

入选标准

  • unilateral open inguinal or umbilical hernia repair
  • capable to understand the risks and commitment associated with the surgery and anesthesia

排除标准

  • concomittant surgical of non-surgical procedure
  • no agreement to informed consent

研究组 & 干预措施

B-group

Spinal anesthesia was performed using 10.5mg bupivacaine with added sufentanil (2µg).

干预措施: Bupivacaine (Drug)

C-group

Spinal anesthesia was performed using 40mg hyperbaric 2-chloroprocaïne with added sufentanil (2µg).

干预措施: Chloroprocaine (Drug)

P-group

Spinal anesthesia was performed using 60mg prilocaïne with added sufentanil (2µg).

干预措施: Prilocaine (Drug)

结局指标

主要结局

Time to void

时间窗: up to 24hours after surgery

Postoperative spontaneous voiding (\>200ml).

次要结局

  • in hospital time(up to 24hours after surgery)
  • time from spinal anesthesia to ready-to-cut(an average of 3 minutes)
  • time from spinal anesthesia to start of surgery(an average of 3 minutes)
  • time to T6(1 hour)
  • time to T10(1 hour)
  • time to onset of peak sensory level block(an average of 60 minutes)
  • peak sensory level (dermatome)(an average of 60 minutes)

研究者

发起方
AZ St.-Dimpna Geel
申办方类型
Other
责任方
Principal Investigator
主要研究者

Ben Gys

md

AZ St.-Dimpna Geel

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