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CTRI Number  CTRI/2023/11/060172 [Registered on: 22/11/2023] Trial Registered Prospectively
Last Modified On: 30/07/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Surgical/Anesthesia 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Comparison of 3 different methods in preventing fall in blood pressure after spinal anaesthesia in elective cesarean section 
Scientific Title of Study   The efficacy of pneumatic leg compression versus leg elevation in preventing post spinal hypotension in elective cesarean section- a randomized controlled trial 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Avasarala Katyayani Vidmahi 
Designation  Junior Resident 
Affiliation  All India Institute of Medical Sciences, Jodhpur 
Address  D&T OT complex 3rd floor AIIMS Jodhpur

Jodhpur
RAJASTHAN
342005
India 
Phone  9010699070  
Fax    
Email  katyayaniavasarala@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Rakesh Kumar 
Designation  Additional Professor 
Affiliation  All India Institute of Medical SciencesJodhpur 
Address  D&T Block 3rd floor OT Complex AIIMS Jodhpur

Jodhpur
RAJASTHAN
342005
India 
Phone  9460429221  
Fax    
Email  drrakeshspmc@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Avasarala Katyayani Vidmahi 
Designation  Junior Resident 
Affiliation  All India Institute of Medical Sciences, Jodhpur 
Address  D&T OT complex, 3rd floor AIIMS Jodhpur

Jodhpur
RAJASTHAN
342005
India 
Phone  9010699070  
Fax    
Email  katyayaniavasarala@gmail.com  
 
Source of Monetary or Material Support  
All India Institute of Medical Sciences, Jodhpur 
 
Primary Sponsor  
Name  All India Institute of Medical Sciences Jodhpur 
Address  Marudhar Industrial Area,Basni Phase 2,Jodhpur,342005 
Type of Sponsor  Research institution and hospital 
 
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 Avasarala Katyayani Vidmahi  All India Institute of Medical Sciences, Jodhpur  Department of Anaesthesiology and Critical Care
Jodhpur
RAJASTHAN 
9010699070

katyayaniavasarala@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee, All India Institute of Medical Sciences, Jodhpur  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: O82||Encounter for cesarean delivery without indication,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Control  No intervention 
Intervention  Leg elevation  Leg elevation 30cm using two cushions placed under heels  
Intervention  Pneumatic leg compression  Pneumatic leg compression bilaterally intermittently using pneumatic leg compression device with inflation time 12 seconds and relaxation time 24seconds 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  45.00 Year(s)
Gender  Female 
Details  1. Patients posted for elective caesarean section 
 
ExclusionCriteria 
Details  1. Patients who do not consent to participate in the study
2. Patients with contraindications for spinal anaesthesia
3. Patients with contraindications for the use of pneumatic compressions like serious
arterial insufficiency, deep venous thrombosis, presence of localized wound infection
or cellulitis, etc
4. Patients with gestational hypertension, preeclampsia, eclampsia
5. Patients converted to general anaesthesia due to inadequate sensory blockade from
spinal anaesthesia 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
To compare the incidence of hypotension between the groups  Till the delivery of baby 
 
Secondary Outcome  
Outcome  TimePoints 
1. To compare the requirement of a rescue dose of phenylephrine
2. To compare the number of rescue doses of phenylephrine
3. To compare the total dose of rescue doses of phenylephrine
4. To compare the adverse effects between groups
5. To compare the comfort of the surgeon 
Till the end of cesarean section 
 
Target Sample Size   Total Sample Size="210"
Sample Size from India="210" 
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   Phase 4 
Date of First Enrollment (India)   30/11/2023 
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="3"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  
Not Applicable 
Recruitment Status of Trial (India)  Open to Recruitment 
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  
The primary method of anaesthesia for caesarean section is spinal anaesthesia.
Hypotension, which is a frequent side effect of spinal anaesthesia and is due to
preganglionic sympathetic suppression, which ultimately results in vasodilatation, is one of
the major side effects. Systolic pressure reduction can affect foetal circulation and uterine
blood flow, which can lead to acidosis and hypoxia in the developing child. According to
the various studies, between 50% and 60% of caesarean sections performed under spinal
anaesthesia result in hypotension. 
Due to the potentially serious consequences for both the mother and the new-born,
spinal anesthesia-induced hypotension after caesarean section must be prevented
and managed. For the management and prevention of PSH, a variety of methods
(pharmacological and physical approaches) have been tried with varying degrees of
success.

Despite being the most popular strategy for treating hypotension, pharmacological
techniques have a variety of undesirable side effects. While phenylephrine is thought to be
the preferred medication, it produces bradycardia and lowers blood supply to the placenta.
Ephedrine crosses the placenta and stimulates beta-adrenergic receptors in the foetus,
increasing foetal metabolic rate.

Leg elevation (LE) increases venous return by directing blood flow from the lower
extremities to the thorax. Therefore, LE boosts cardiac output (CO) via increasing stroke
volume (SV). In order to avoid PSH, LE is a simple, non-invasive, and
non-pharmacological method.

Intermittent pneumatic compression (IPC) of the lower extremities prevents blood from accumulating in the legs by generating circumferential compressions and decompressions
at precise pressures. They have mostly been utilised for venous thromboembolism
prevention and major urological surgery. [ 5-7] Despite this, there are few studies on the
hemodynamic effects of pneumatic leg compression during spinal anaesthesia. To the best
of our knowledge, research studies have not examined the effectiveness of pneumatic
compression and leg elevation in preventing post-spinal hypotension or spinal
anesthesia-induced hypotension following caesarean delivery. This investigation compares
the effectiveness of pneumatic compression versus leg elevation in reducing post-spinal
hypotension during caesarean delivery.
 
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