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临床试验/NCT02245126
NCT02245126已完成不适用

The Use of Lignocaine and Bupivacaine Mix in Adult Safe Male Circumcision; Less is More

International Hospital Kampala1 个研究点 分布在 1 个国家目标入组 217 人开始时间: 2013年1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
217
试验地点
1
主要终点
pain score

研究概览

简要总结

Using routinely collected data to compare different concentrations of locally applied anaesthetic drugs and determine which concentrations give better pain control during voluntary medical Male circumcision.

详细描述

The objective of this study therefore was to assess self-reported pain and adverse events when using two different concentrations of lignocaine and bupivacaine mixture while performing routine safe medical circumcision (SMC).

Methods Design This was an observational analytical study.

Setting At an urban high volume SMC site in a resource limited setting, over a 6 weeks period.

Participants Adult males aged18 - 49 years presenting for routine voluntary SMC were recruited for enrollment. All men were offered voluntary HIV counseling and testing before the surgery, received group counseling /health education on HIV prevention, were offered HIV testing, individual counseling where necessary to address questions and to clarify any queries, and free condoms were available. All participants were screened for contraindications to SMC such as active sexual transmitted infections (STI), commonly manifesting as urethral discharge or penile ulcers.

Ethical consideration All participants after they were counselled and provided written informed consent. Ethical approval was obtained from the Makerere College of Health Sciences Ethics and Research Committee.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 49 Years(Adult)
性别
Male
接受健康志愿者

入选标准

  • all adult male aged18 and 49 years

排除标准

  • severe comorbid states such as sickle cell disease
  • uncontrolled diabetes
  • hypertension
  • active sexually transmitted infections and genital ulcers
  • in addition known allergy to lidocaine or bupivacaine

研究组 & 干预措施

Lignocaine-bupivacaine lower dosage mix

Experimental

Men who received the 3-3-4 local anaesthetic mix( 3 cc of lignocaine 2% , 3cc of bupivacaine 0.5% and 4cc of water for injection)

3-3-4 mix was administered

干预措施: 3-3-4 mix (Drug)

Lignocaine-bupivacaine higher dosage mix

Active Comparator

In this group (4-4-2 group) eligible men were receiving an injection of the 4-4-2 local anesthetic mix ( composed of 4cc of parental lignocaine 2%, 4cc of parental bupivacaine 0.5% and 2cc of water for injection). This mix is given once before commencement of the surgical procedure safe male circumcision.

干预措施: 4-4-2 (Drug)

结局指标

主要结局

pain score

时间窗: immediate post operative period

measure at intervals after the procedure is completed

次要结局

未报告次要终点

研究者

发起方
International Hospital Kampala
申办方类型
Other
责任方
Principal Investigator
主要研究者

Moses Galukande

director of Surgery

International Hospital Kampala

研究点 (1)

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