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CTRI Number  CTRI/2024/11/077361 [Registered on: 26/11/2024] Trial Registered Prospectively
Last Modified On: 24/12/2024
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Surgical/Anesthesia 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Randomised controlled single blinded study comparing traditional lumbar subarachnoid block with novel thoracic segmental subarachnoid block for Lower Segment cesarean section in Indian population in terms of perioperative outcomes 
Scientific Title of Study   Comparative study of traditional lumbar subarachnoid block vs novel thoracic subarachnoid block for cesarean section: A randomised single blinded 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  Damarla Haritha 
Designation  Assistant Professor 
Affiliation  Narayana Medical College 
Address  Operation Theatre complex, second floor, Narayana General Hospital, Chintareddy Palem, Nellore

Nellore
ANDHRA PRADESH
524003
India 
Phone  8096455970  
Fax    
Email  damarlaharitha007@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Damarla Haritha 
Designation  Assistant Professor 
Affiliation  Narayana Medical College 
Address  Operation Theatre complex, second floor, Narayana General Hospital, Chintareddy Palem, Nellore

Nellore
ANDHRA PRADESH
524003
India 
Phone  8096455970  
Fax    
Email  damarlaharitha007@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Damarla Haritha 
Designation  Assistant Professor 
Affiliation  Narayana Medical College 
Address  Operation Theatre complex, second floor, Narayana General Hospital, Chintareddy Palem, Nellore

Nellore
ANDHRA PRADESH
524003
India 
Phone  8096455970  
Fax    
Email  damarlaharitha007@gmail.com  
 
Source of Monetary or Material Support  
Narayana Medical College, Chintareddypalem, Nellore, Andhra Pradesh. PIN: 524003 
 
Primary Sponsor  
Name  None 
Address  Not applicable 
Type of Sponsor  Other [] 
 
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 Damarla Haritha  Narayana Medical College  2nd floor. Operation Theatre complex, Narayana General Hospital
Nellore
ANDHRA PRADESH 
8096455970

damarlaharitha007@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institute Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: O80||Encounter for full-term uncomplicated delivery,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Lumbar subarachnoid block  Under all aseptic precautions in sitting position, hyperbaric bupivacaine 0.5% (10mg) with preservative free buprenorphine 60mcg (total volume 2.2ml) is administered at L3-L4 or L4-L5 levels into the subarachnoid space after confirmation of free flow of cerebrospinal fluid 
Intervention  Thoracic segmental subarachnoid block  Under all aseptic precautions in sitting position hyperbaric bupivacaine 0.5% (6mg) with preservative free buprenorphine 60mcg (Total volume 1.6ml) is administered at T9-T10 or T10-T11 levels into the subarachnoid space after confirmation of free flow of cerebrospinal fluid 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  40.00 Year(s)
Gender  Female 
Details  1. Age more than 18 years
2. ASAPS 2 and 3
3. Elective cases posted for Cesarean section under neuraxial anaesthesia
 
 
ExclusionCriteria 
Details  1. Refuse to consent
2. BMI more than 35 kg/m2
3. ASAPS more than 3
4. Contraindication to neuraxial block 
 
Method of Generating Random Sequence   Other 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
To estimate the duration of motor blockade through
1. Ability of the patient to slide out of the table with flexion at the hip by the end of the surgery
2. Time to be able to sit from the side of the bed with legs dangling
3. Time to walk with support
 
Throughout PACU stay 
 
Secondary Outcome  
Outcome  TimePoints 
To estimate the incidence of following perioperative outcomes:
1. Incidence of nausea, vomiting, and shivering.
2. Hemodynamic stability
3. Requirement of sedation
4. Abdominal muscle relaxation
5. Postoperative urinary retention
6. Incidence of PDPH, neurological complications
 
Till the time of hospital discharge 
 
Target Sample Size   Total Sample Size="80"
Sample Size from India="80" 
Final Enrollment numbers achieved (Total)= "110"
Final Enrollment numbers achieved (India)="110" 
Phase of Trial   N/A 
Date of First Enrollment (India)   02/12/2024 
Date of Study Completion (India) 28/02/2025 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="0"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  
Not Applicable 
Recruitment Status of Trial (India)  Completed 
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  

Cesarean delivery is one of the most common surgeries performed globally. Neuraxial anaesthesia is preferable to general anaesthesia for cesarean delivery as it is associated with less maternal and neonatal morbidity and mortality. Traditionally, spinal anaesthesia is administered in the lumbar region to avoid spinal cord injury. Recent MRI studies indicate a more substantial depth of the posterior subarachnoid space in the thoracic spinal cord and therefore showed no neurological sequelae at the thoracic level, and the incidence of paresthesia was similar to that seen at the lumbar level. The total amount of CSF in the thoracic segment is less when compared to the lumbar and cervical segments, causing easy blockade of roots and a reduction in the dose of the drug required, along with improved muscle relaxation. During lumbar spinal anaesthesia, the sympathetic blockade extends to the lower limbs resulting in vasodilation of the blood vessels and reduction in preload. During thoracic spinal anaesthesia, the sympathetic block is restricted to fewer dermatomes with minimal involvement of the lower limbs, therefore, a smaller reduction in preload and blood pressure is seen. Thoracic segmental spinal anaesthesia has been gaining popularity in recent times and has been successfully performed for abdominal cancer surgeries, breast surgeries, laparoscopic cholecystectomies, and nephrolithotomies. In pregnant females posted for cesarean section, thoracic spinal anaesthesia helps in early mobilisation postoperatively, which meets the goals of enhanced recovery after surgery (ERAS). It also helps with the early initiation of breastfeeding, ensuring that the infant receives colostrum while facilitating the emotional bonding between the mother and the baby. We are thus conducting this study to explore the effectiveness of performing thoracic segmental spinal anaesthesia in patients posted for elective cesarean surgery under neuraxial blockade

 
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