跳至主要内容
临床试验/CTRI/2014/09/005037
CTRI/2014/09/005037已完成不适用

EVALUATION OF EFFICACY OF VALSALVA FOR ATTENUATING LUMBAR PUNCTURE PAIN

Sanjay Gandhi Postgraduate Institute Of Medical Sciences1 个研究点 分布在 1 个国家目标入组 90 人开始时间: 2014年3月24日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
90
试验地点
1
主要终点
To evaluate the efficacy of valsalva procedure in attenuating the lumber puncture pain

研究概览

简要总结

Aims and objectives:

 Primary objective: To evaluate the efficacy of valsalva procedure in attenuating the lumber puncture pain

 Secondary objective:  To evaluate the efficacy of valsalva procedure on CSF flow

 Methodology: Patients will be randomized with the help of a computer-generated table of random numbers into 3 groups of 30 each. Group I (Control): acted as control and did not perform valsalva nor blew through a open tube; group II (Distraction): patients were asked to blow through a rubber tube not connected to sphygmomanometer; Group III (Valsalva):  patients were asked to blow into a rubber tubing connected to sphygmomanometer and raise the mercury column up to 30 mmHg for a period of at least 20 sec. During the valsalva spinal puncture would be performed with a 26 G spinal needle.

 Exclusion: obese patients, history of previous spinal surgery, patient’s refusal for spinal, patients requiring > 1 attempt for successful spinal or change of inter vertebral space

 Risks associated with the procedure are none as in ASA 1 and 2 patients; however, valsalva procedure has been reported to attenuate pain in animal studies and more so in humans for minimizing venous cannulation pain in adults and paediatric patients. We therefore wish to evaluate its efficacy in attenuating the lumber puncture pain.

研究设计

研究类型
Interventional
分配方式
Computer generated randomization
盲法
Participant, Investigator and Outcome Assessor Blinded

入排标准

年龄范围
18.00 Year(s) 至 75.00 Year(s)(—)
性别
All

入选标准

  • •Adult(ASA grade I and II)of age group 18-75yrs.

排除标准

  • •Patients having problems in communication, abnormal skin condition such as infection at the site of proposed lumber puncture, scars, eczema, obese patients, history of previous spinal surgery, patient’s refusal for spinal, patients requiring > 1 attempt for successful spinal or change of inter vertebral space.
  • •Patients who could not hold the mercury column up to 30 mmHg for a period of at least 20 seconds.

结局指标

主要结局

To evaluate the efficacy of valsalva procedure in attenuating the lumber puncture pain

时间窗: 6 months

次要结局

  • To evaluate the efficacy of valsalva procedure on CSF flow

研究者

申办方类型
Research institution and hospital

研究点 (1)

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