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临床试验/CTRI/2024/06/069238
CTRI/2024/06/069238尚未招募不适用

Comparison of sitting versus lateral decubitus position during spinal anaesthesia on the occurrence of post dural puncture headache in patients undergoing lower segment caesarean section

Kiran arashibhai rathod1 个研究点 分布在 1 个国家目标入组 140 人开始时间: 2024年7月1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
140
试验地点
1
主要终点
Incidence and Severity of PDPH

研究概览

简要总结

INTRODUCTION:

  1. Majority of caesarian section are performed in spinal anaesthesia because of its

high safety profile, so the incidence of PDPH has also increased.

  1. PDPH headache is posture dependent. It occurs when patient resumes upright

position and is characterized by dull pain in fronto-occipital area and relieves on

lying down. It may be associated with nausea, vomiting, auditory and visual

symptoms. Pain may radiate to the neck and may be associated with neck

stiffness.

  1. Different risk factors are considered like characteristics of patient

population, characteristics of needle used, puncture technique, number of

punctures and many others. The use of spinal needles of smaller gauge has

decreased the incidence from 30 % to 0.3%. Of many risk factors, one of the

factors assumed is related with the position of the patient while doing dural

puncture, either in sitting or lateral position.

  1. Very few articles have been found in review of literature regarding patient’s

position in causing PDPH following spinal Anaesthesia. This study is designed

to compare the incidence of PDPH following spinal anaesthesia in sitting and

lateral position.

AIMS:

The Aim of this present study is to determine the effects of sitting versus lateral

position during spinal anaesthesia on the occurrence of Post dural puncture

headache (PDPH) in lower segment cesarean section (L.S.C.S).

OBJECTIVES:

To compare the incidence and severity of post dural puncture headache (PDPH)

among pregnant women based on the different positions while induction of

Spinal Anaesthesia.

MATERIAL AND METHOD:

Based on previous Studies Anup et al. and using formula for sample size

calculations n = 2[(Zα+Z1-B) Ʊ ]2 /Δ2

Where,

Zα (confidence 95%) = 1.96%,

Z1-B (power 80%) = 0.8416

Ʊ= population variance (SD) conventionally taken as 20

Δ= expected difference between the two groups 10%

N is found to be 63, i.e., 63 parturient will to be included in each of the groups

in the study to detect a significant relation between position for induction of

spinal anesthesia and occurrence of PDPH. Total of 140 parturient, 70 in each

group to compensate for drop- outs, would be included to detect a difference

between the 2 groups.

DRUG: 0.5% Hyperbaric Bupivacaine 2 ml (10mg)

NEEDLE: 25 G Quincke’s Spinal Needle

METHODOLOGY:

The written informed consent will be taken from 140 American Society of

Anesthesiologists (ASA) physical status class I and II pregnant women

admitted under the Department of Obstetrics and Gynecology, PDU

medical college, requiring elective Caesarean Section (CS), satisfying the

inclusion criteria.

They will be randomly allocated into 2 equal groups by simple random

sampling using shuffled closed sealed envelope technique, namely Group-

S & Group - L.

• GROUP S (SITTING POSTURE) : Spinal Anaesthesia will be

administered in the sitting posture

• GROUP L(LATERAL POSTURE ) : Spinal Anaesthesia will be

administered in lateral posture

Pre-anesthetic Evaluation (PAE) of all the selected pregnant women would

be done on the previous day and written informed consent will be taken.

All the parturient will be informed about nil per oral status of at least 6hrs

for solids and 2hrs for clear liquids. On the morning just before giving

spinal anaesthesia all parturient will be given intravenous (IV) ondansetron

0.08mg/kg and patients will be coloaded with ringer lactate 10ml/kg

bodyweight.

After connecting multipara meter monitors with ECG, pulse oximeter and

Non-Invasive Blood Pressure (NIBP), basal parameters will be recorded.

Spinal anesthesia using 25G Quincke’s needle using 2ml of 0.5%

Hyperbaric Bupivacaine will be given in sitting position in Group S

parturient and in lateral position in L group, then patient will be turned

immediately to supine posture with a wedge underneath right buttock. In

both the groups the bevel of the needle will be kept parallel to the

longitudinal axis of spinal cord.

The spinal anesthesia will be given by the resident of anaesthesia who was

involved with randomization of parturient and the observer will be a

different resident of anaesthesia who will be entered in the operation theatre

after the parturient will be brought to supine position. By this, the observer

will be blinded to the study position. Sensory block will be tested by pin

prick method using a blunt tip 25G needle. Motor block will studied using

Modified Bromage Scale (0= No paralysis, 1= Unable to raise extended leg;

able to bend knees, 2 = Unable to bend knee, able to flex ankle, 3 = No

movement). Surgery will be allowed to start once the sensory block reached

T6 - T4 level.

OBSERVATION & RESULTS:

SA will be given to parturient either in the sitting (group S) or the right lateral

decubitus position (group L), using 2 ml 0.5% hyperbaric Bupivacaine using 25G

Quincke’s spinal needle, and will be immediately made supine. All characteristics,

including sensory & motor block, haemodynamic will be noted. Post-operative

nausea and vomiting (PONV) will be assessed by simply asking the patients. For

post-dural puncture headache (PDPH), patients will be questioned regarding

frontal and occipital region headache on the post-operative day 1 to day 5. PDPH

will be divided into four stages: No headache (0), mild (1-3), moderate (4-6) and

severe (7-9) using numerical rating scale for pain.

STATISTICAL ANALYSIS:

Student’s independent t-test will be used to compare age, weight, BMI and height

between the two groups. The chi-square test will be used to assess the relativity

between position and complications. p-value less than 0.05 would be considered

statistically significant. All statistical calculations will be performed using SPSS

version 16 software.

BENEFITS:

By comparing the incidence and severity of post dural puncture headache (PDPH)

among pregnant women based on the different positions while induction of Spinal

Anaesthesia we will able to reduce median length of hospital stay and reduce

postoperative complications.

RISKS:

There is no risk in the study as we will just observing the patients and not

interfering in anyway with patient’s treatment.

研究设计

研究类型
Observational

入排标准

年龄范围
19.00 Year(s) 至 40.00 Year(s)(—)
性别
Female

入选标准

  • Asa grade I&II Elective caesarean section Sigle tone pregnancy Height between 150 to 170cm BMI less than 30kg per m2.

排除标准

  • Pregnant women having contraindication for spinal anaesthesia, ex.
  • Local infection, allergy to local anesthetics, bleeding disorders, spinal deformity, severe congenital or acquired heart disease, hemorrhage , hypovolemic shock; Any obstetrics complications like preeclampsia, gestational diabetes, placenta praevia ; More than one lumber puncture; History of migraine headache; Chronic use of analgesics; patients refusall.

结局指标

主要结局

Incidence and Severity of PDPH

时间窗: Post operative day-1, day-2, day-3, day-4 and day-5

次要结局

  • Associated features such as Nausea & Vomiting, Photophobia etc.(Post operative day-1, day-2, day-3,day-4 & day-5)

研究者

发起方
Kiran arashibhai rathod
申办方类型
Other [self]
责任方
Principal Investigator
主要研究者

Kiran arashibhai rathod

PDU Medical college rajkot

研究点 (1)

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