A Comparison Of Incidence Of Post Dural Puncture Headache With 25G Quincke’s And 25G Whitacre’s Spinal Needles Following Spinal Anaesthesia
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 86
- 试验地点
- 1
- 主要终点
- Incidence of post dural puncture headache
研究概览
简要总结
Participants satisfying the inclusion criteria will be evaluated after
obtaining informed written consent.
A thorough pre-anaesthetic evaluation will be done a day prior to surgery. Patient shall be
prepared as per institutional protocol. All patients will be coloaded with 500 ml of
appropriate IV fluid as per standard institutional protocol.
As per the standard procedure, using the midline approach of spinal anaesthesia using
Quincke’s or Whitacre’s spinal needle will be inserted into L3-L4 subarachnoid space and
0.5% of hyperbaric bupivacaine will be injected into the space by a trained anaesthesiologist.
Level of sensory and motor block will be assessed.
All the non-invasive hemodynamic monitoring will be used to record the vitals.
Patient and the observer will be blinded from the type of needle used for spinal anaesthesia.
All patients will be examined on the day of surgery and there after every day for the next ten
days.
The patients will be assessed on post operative day one for signs of PDPH and followed up
till day ten. After day of discharge, will be followed up via telephonic communication. The
following information will be collected from the anaesthesiologist giving the subarachnoid
block about the type of needle used, size, approach, position, number of attempts, ease of
puncture.
After assessing the patients on POD10 about headache with regards to its severity, onset,
effect of posture and associated symptoms like nausea, vomiting, auditory and ocular
symptoms the patients will be allocated into groups Q and W after obtaining information
regarding the procedure from the anaesthesiologist. Accordingly, assessment of more than the
sample size will be done and patients not satisfying the inclusion criteria will be excluded
based on usage of different type and size of needle used. Study will be concluded once the
sample size is reached.
The collected data will be entered into MS Excel followed by the analysis using SPSS
version 22/R Core Team (2023). The comparison of post dural puncture headache following spinal anaesthesia, ease of
puncture and number of attempts between the two groups will be done using Chi Square test/
Fishers exact test/Proportion test. P value<0.05 will be considered statistically significant.
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 18.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- All
入选标准
- •Patients in the age group of 18 to 65 years undergoing SAB using 25G Quincke needle or Whitacre needle.
- •ASA PS I and II.
排除标准
- •Pregnant patients Intraop General anesthesia administration Migraine or other neurological or chronic headache patients BMI more than 35.
结局指标
主要结局
Incidence of post dural puncture headache
时间窗: Daily from post operative period upto post operative day 10.
次要结局
- Onset(Onset evaluated at Postoperative day 1 to Postoperative day 10.)
- Postural effect(Daily at post operative day 1 to post operative day 10.)
- Any associated symptoms present?(At post operative day 1 to post operative day 10.)
研究者
Dr Disney Das
KS Hegde Medical Academy