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CTRI Number  CTRI/2024/06/069238 [Registered on: 19/06/2024] Trial Registered Prospectively
Last Modified On: 18/06/2024
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Follow Up Study 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Comparison of Headache in Patients Undergoing Caesarean Section  
Scientific Title of Study   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 
Trial Acronym  Nil 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Kiran arashibhai rathod 
Designation  Second year MD anaesthesiology resident 
Affiliation  PDU Medical college rajkot 
Address  Department of anaesthesia, PDU medical college, Rajkot, Gujarat

Rajkot
GUJARAT
360001
India 
Phone  7984803390  
Fax    
Email  kiranrathod80187@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Shaikh Abdul Nasir 
Designation  Associate professor, Department of Anaesthesiology 
Affiliation  PDU Medical college rajkot 
Address  Department of Anaesthesiology, PDU medical college, Rajkot

Rajkot
GUJARAT
360001
India 
Phone  8200889345  
Fax    
Email  dashingready@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Shaikh Abdul Nasir 
Designation  Associate professor, Department of Anaesthesiology 
Affiliation  PDU Medical college rajkot 
Address  Department of Anaesthesiology, PDU medical college, Rajkot

Rajkot
GUJARAT
360001
India 
Phone  8200889345  
Fax    
Email  dashingready@gmail.com  
 
Source of Monetary or Material Support  
Department of Anaesthesia,PDU medical college, Rajkot, 360001, Gujarat, India 
 
Primary Sponsor  
Name  Kiran arashibhai rathod 
Address  Department of Anaesthesia, P.D.U. Medical College and Hospital, Rajkot, 360001, Gujarat, India 
Type of Sponsor  Other [Self] 
 
Details of Secondary Sponsor  
Name  Address 
Nil  Nil 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr kiran rathod  PDU medical college, Rajkot  Third floor,Obstetric department,New MCH JANANA building,PDU medical college, Rajkot
Rajkot
GUJARAT 
7984803390

Kiranrathod80187@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee (Human) P.D.U. Medical College, Rajkot.  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: O745||Spinal and epidural anesthesia-induced headache during labor and delivery, (2) ICD-10 Condition: 4||Measurement and Monitoring, (3) ICD-10 Condition: O746||Other complications of spinal andepidural anesthesia during labor and delivery, (4) ICD-10 Condition: O||Medical and Surgical,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Occurrence of Postdural puncture headache after spinal anaesthesia   After giving spinal anaesthetia patients will be observed for 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. 
Intervention  Position for spinal anaesthesia  There will be two group, In group -L spinal anaesthesia will be given in the right lateral decubitus position using 2 ml 0.5% hyperbaric Bupivacaine using 25G quinckes spinal needle and immediately made supine; in Group-S spinal anaesthesia will be given in the sitting position using 2 ml 0.5% hyperbaric Bupivacaine using 25G quinckes spinal needle and immediately made supine.Patient will be observed for including sensory & motor block, haemodynamic will be noted 
 
Inclusion Criteria  
Age From  19.00 Year(s)
Age To  40.00 Year(s)
Gender  Female 
Details  Asa grade I&II
Elective caesarean section
Sigle tone pregnancy
Height between 150 to 170cm
BMI less than 30kg per m2 
 
ExclusionCriteria 
Details  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 
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant and Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
Incidence and Severity of PDPH  Post operative day-1, day-2, day-3, day-4 and day-5 
 
Secondary Outcome  
Outcome  TimePoints 
Associated features such as Nausea & Vomiting, Photophobia etc.  Post operative day-1, day-2, day-3,day-4 & day-5 
 
Target Sample Size   Total Sample Size="140"
Sample Size from India="140" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   N/A 
Date of First Enrollment (India)   01/07/2024 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="1"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary  
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.
2. 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.
3. 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.
4. 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.

 
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