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临床试验/ACTRN12621000584831
ACTRN12621000584831招募中2 期

Paracervical local anaethesia to mitigate post operative pain after total laparoscopic hysterectomy: A single centered, randomised, double-blinded, placebo-controlled, phase II study comparing the use of the paracervical block versus placebo.

St John of God Subiaco Hospital0 个研究点目标入组 94 人开始时间: 2021年5月17日最近更新:

试验速览

阶段
2 期
状态
招募中
发起方
入组人数
94

研究概览

简要总结

暂无简介。

研究设计

研究类型
Interventional
分配方式
Randomised controlled trial
主要目的
Prevention
盲法
Blinded (masking used)

入排标准

年龄范围
18 Years 至 o limit(—)
性别
Female

入选标准

  • 1.Women undergoing a total laparoscopic hysterectomy (TLH) plus or mimus bilateral
  • Salpingo-oophorectomy (BSO) for any of the following conditions:
  • a. Heavy menstrual bleeding/ abnormal uterine bleeding
  • b. Stage 1 and 2 Endometriosis
  • c. Adenomyosis
  • d. Risk reduction surgery e.g. carriers of BRCA1/2 gene faults, Lynch Syndrome or
  • women considered high risk due to family history
  • e. Complex adnexal masses not suspicious for malignancy
  • f. Early stage cervical cancer requiring simple hysterectomy
  • 2.Patients aged 18 years of age and over
  • 3.Fluent in English

排除标准

  • 1.Chronic pelvic pain
  • 2.Recent opioid use (4 weeks prior to surgery)
  • 3.Deeply infiltrative endometriosis (evidence of nodular disease on USS) or endometrioma.
  • 4.Allergies to protocol drugs
  • 5.Endometrial cancer
  • 6.Patient requiring comprehensive surgical staging of malignant disease
  • 7.Previous midline laparotomy
  • 8.BMI >40kg/m2
  • 9.Renal impairment (eGFR< 60 or Cr > 100)
  • 10.Hepatic impairment (ALT> 40 or AST > 40)
  • 11.Alcohol and drug dependency
  • 12.Pregnancy

研究者

发起方
St John of God Subiaco Hospital

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