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临床试验/CTRI/2024/06/068667
CTRI/2024/06/068667尚未招募不适用

Prospective observational study for incidence of post dural puncture backache and post dural puncture headache in parturients undergoing cesarean delivery under spinal anaesthesia

Vijaynagar institute of medical sciencesBallari1 个研究点 分布在 1 个国家目标入组 150 人开始时间: 2024年6月25日最近更新:

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
150
试验地点
1
主要终点
To know the incidence of PDPH and PDPB.

研究概览

简要总结

The study aims at knowing incidence of PDPB and PDPH in 150 parturients undergoing cesarean delivery under spinal anaesthesia.

Study to include pregnant women of age 18 - 45 years undergoing cesarean section under spinal anaesthesia. The number of attempts (skin punctures, needle passes and needle redirections) for successful dural puncture will be noted. Successful identification of the subarachnoid space with one skin puncture and no redirection of the spinal needle will be considered as first pass success**,** landmark quality (good, poor, none), needle passes, space level change, second provider, bloody tap, intra operative fluid given will be observed.Postoperatively severity of PDPB will be assessed by visual analogue scale (VAS 1‑10) score; 0 = no backache,1–3 = mild backache, 4–7 = moderate backache, >7 = severe backache. And severity of PDPH will be assessed by NRS scale. On the scale, 0 is the absence of headache, 1–3 is mild pain, 4–6 is moderate pain, and 7– 10 is severe pain (disabling; unable to perform daily activities). Postoperatively the incidence of PDPB and incidence of PDPH will be assessed on day 1,3, 5 of hospital stay. In the study phone number of the patient/attender will be taken, going to call them back after 1month, 2month, 3 month to know the well being of the patient, any side effects in particular to PDPB.

Statistical Analysis; The collected data will be entered in the Microsoft Excel 2016 and will be analysed wih IBM SPSS Statistics for Windows, Version 29.0.(Amonk,NY:IBM Corp)

研究设计

研究类型
Observational

入排标准

年龄范围
18.00 Year(s) 至 45.00 Year(s)(—)
性别
Female

入选标准

  • All pergnant women aged 18-45 years undergoing cesarean section under spinal anaesthesia.

排除标准

  • Patient refusal, Contraindications of spinal anaesthesia like coagulopathy, Infection at the site of puncture, Hemodynamically unstable, Eclampsia, Allergic to local anaesthetics.

结局指标

主要结局

To know the incidence of PDPH and PDPB.

时间窗: Postoperatively the incidence of PDPB and PDPH will be assessed on day 1,3,5 of hospital stay and after 1month, 2month and 3 months after discharge

次要结局

  • Secondary outcomes include factors like : body mass index, pregnancy induced hypertension, poor quality of spinal landmarks, number of skin punctures, needle passes, space level change, size of spinal needle, number of attempts, spinal needle redirections, 1st pass success, second provider, occurrence of bloody tap, number of previous caesarean sections, leakage of CSF(Postoperatively the incidence of PDPB & PDPH will be assessed on day 1,3,5 of hospital stay & after 1month, 2month & 3 months after discharge)

研究者

发起方
Vijaynagar institute of medical sciencesBallari
申办方类型
Government medical college
责任方
Principal Investigator
主要研究者

Shravanthi B S

Vijaynagar institute of medical sciences,Ballari

研究点 (1)

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