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临床试验/NCT02368054
NCT02368054已完成4 期

Hemodynamic Stability of Bupivacaine With and Without Adrenaline for Paracervical Block for Cervical Conization During General Anesthesia: A Randomized Controlled Double Blinded Study

Helse Fonna1 个研究点 分布在 1 个国家目标入组 34 人开始时间: 2015年5月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
4 期
状态
已完成
发起方
入组人数
34
试验地点
1
主要终点
Changes in Cardiac Output as measured by LiDCOplus monitor.

研究概览

简要总结

Cervical conization is done for pre-cancer disease. The procedure is performed with local anesthesia and general anesthesia. Local anesthesia is given by paracervical block, and several different local anesthetics is being used including bupivacaine with and without adrenaline. Adrenaline might reduce local bleeding and reduce toxicity of bupivacaine by reducing absorption, but might affect cardiovascular function. This study will examine this effect.

详细描述

Most patients scheduled for cervical conization are healthy, young women. Some do this procedure with local anesthesia (paracervical block) and sedation, others general anesthesia combined with local anesthesia. Lidocaine with adrenaline is often used, but some uses longer acting substances like bupivacaine 2,5 mg/ml with adrenaline 5 microg/ml.

Adding of adrenaline prolongs the effect of anesthesia and the effect is probably strongest for short-acting local anesthetics. Adrenaline may delay absorption of local anesthetics avoiding toxic plasma concentrations and reduce local bleeding. Injection of local anesthetics with adrenaline may affect haemodynamic stability.

Para-cervical block has been used for analgesia in first stage of labor, but may give foetal bradycardia in 3-4 % and may affect the cardiotocogram in 10-12%. This effect is observed with bupivacaine and the less toxic levobupivacaine. Because of fear for complications and foetal injury this block has been replaced by more effective and safer methods like epidural and spinal anesthesia.

In gynecological practice the para-cervical block is still used for termination of pregnancy, cervical conization and for instrumentation of uterus.

We have observed affection of hemodynamic stability when using local anesthetics with adrenaline in nasal mucosa and during cervical conization. Some patients may experience increase or decrease in blood pressure and heart rate with a duration of 3-5 minutes.

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
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 50 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • Clinical diagnosis of cervical pre-cancer

排除标准

  • Pregnancy
  • Feeding mother
  • Bad nutritional state
  • Infection
  • Treatment for hypertension
  • Diabetes for many years or complications
  • Cardiovascular disease
  • Serious anemia
  • Cardial arrythmia
  • Serious liver-disease
  • Hypersensitivity to local anesthesia of amide-type

研究组 & 干预措施

Bupivacaine-adrenaline

Active Comparator

Paracervical block. Bupivacaine 2,5 mg/ml Adrenaline 5 microg/ml; 20 ml

干预措施: Bupivacaine (Drug)

Bupivacaine-adrenaline

Active Comparator

Paracervical block. Bupivacaine 2,5 mg/ml Adrenaline 5 microg/ml; 20 ml

干预措施: Adrenaline (Drug)

Bupivacaine

Active Comparator

Paracervical block. Bupivacaine 2,5 mg/ml; 20 ml

干预措施: Bupivacaine (Drug)

结局指标

主要结局

Changes in Cardiac Output as measured by LiDCOplus monitor.

时间窗: 0-10 minutes

After paracervical Block.

次要结局

  • Changes in Stroke Volume as measured by LiDCOplus monitor.(0-10 minutes)
  • Changes in Heart Rate as measured by LiDCOplus monitor.(0-10 minutes)
  • Changes in Total Peripheral Resistance as measured by LiDCOplus monitor.(0-10 minutes)

研究者

发起方
Helse Fonna
申办方类型
Other
责任方
Principal Investigator
主要研究者

Gunnar Helge Sjøen

Anesthesiologist

Helse Fonna

研究点 (1)

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