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CTRI Number  CTRI/2025/05/087775 [Registered on: 28/05/2025] Trial Registered Prospectively
Last Modified On: 28/05/2025
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   COMPARISION OF HEMODYNAMIC STABILITY- CONTINUOUS SPINAL ANAESTHESIA VS. SINGLE DOSE SPINAL ANAESTHESIA 
Scientific Title of Study   Comparative study of haemodynamic stability in continuous spinal anaesthesia (CSA) vs single dose spinal anaesthesia (SDSA) in lower limb orthopedic surgeries 
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 Madhavi Chaudhari 
Designation  PROFESSOR,DEPARTMENT OF ANAESTHESIOLOGY 
Affiliation  Pramukh Swami Medical College,Bhaikaka university 
Address  Department of Anaesthesiology, H M Patel Center for Medical Care and Education,Karamsad,Anand, Gujarat

Anand
GUJARAT
388325
India 
Phone  9427084963  
Fax    
Email  madhavic@charutarhealth.org  
 
Details of Contact Person
Scientific Query  
Name  Dr Nishtha Shah 
Designation  Resident 
Affiliation  Pramukh Swami Medical College,Bhaikaka university 
Address  Department of Anesthesiology, H M Patel Center for Medical Care and Education, Karamsad, Anand, Gujarat.

Anand
GUJARAT
388325
India 
Phone  9974337767  
Fax    
Email  nishthashah1d@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Nishtha Shah 
Designation  Resident 
Affiliation  Pramukh Swami Medical College,Bhaikaka university 
Address  Department of Anesthesiology, H M Patel Center for Medical Care and Education, Karamsad, Anand, Gujarat.

Anand
GUJARAT
388325
India 
Phone  9974337767  
Fax    
Email  nishthashah1d@gmail.com  
 
Source of Monetary or Material Support  
SHREE KRISHNA HOSPITAL, PRAMUKH SWAMI MEDICAL COLLEGE, KARAMSAD, ANAND, GUJARAT 
 
Primary Sponsor  
Name  Shree Krishna Hospital 
Address  Shree Krishna Hospital, Karamsad, Anand 388325 
Type of Sponsor  Private medical college 
 
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 MADHAVI CHAUDHARI  Pramukh Swami Medical College  Department of anaesthesiology SHREE KRISHNA HOSPITAL, KARAMSAD, ANAND
Anand
GUJARAT 		 9427084963

madhavic@charutarhealth.org 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
INSTITUTIONAL ETHICS COMMITEE-2  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: 8||Other Procedures,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  CONTINUOUS SPINAL ANAESTHESIA.  Continuous Spinal Anaesthesia with Initial dose of 0.5% hyperbaric BUPIVACAINE 10 mg (2 ml) 
Comparator Agent  SINGLE DOSE SPINAL ANAESTHESIA   Single Dose Spinal Anaesthesia with Total dose of 0.5% hyperbaric BUPIVACAINE 18-19 mg (3.6-3.8 ml) 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  85.00 Year(s)
Gender  Both 
Details  1. Patients undergoing Continuous Spinal Anaesthesia and Single Dose Spinal
Anaesthesia for lower limb orthopedic surgery. 2. 18 to 85 years old patients. 3. American Society of Anaesthesiologists Physical Status grade I-V 
 
ExclusionCriteria 
Details  1.Patients refusing in taking part in the study
2. Allergy to local anaesthetic drug
4. Patients with known bleeding disorders and significantly abnormal coagulation
profiles.
4. Local infection at the proposed site of catheter insertion 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant and Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
To Compare the Intra operative haemodynamic stability in Continuous
Spinal Anaesthesia (CSA) vs. Single Dose Spinal Anaesthesia (SDSA) in Lower Limb
Orthopedic Surgeries. 		 0 minutes, 20 minutes 
 
Secondary Outcome  
Outcome  TimePoints 
1.Patients refusing in taking part in the study
2. Allergy to local anaesthetic drug
4. Patients with known bleeding disorders and significantly abnormal coagulation
profiles. 5. Local infection at the proposed site of catheter insertion 		 0 minutes, 20 minutes 
 
Target Sample Size   Total Sample Size="64"
Sample Size from India="64" 
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)   10/06/2025 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  10/06/2025 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="1"
Months="0"
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  
After obtaining ethical committee’s approval and written informed consent patients undergoing lower
limb orthopedic surgeries under Continuous Spinal Anaesthesia and Single Dose Spinal Anaesthesia
will be recruited in this study.
Participants will be allotted in to two groups through balanced randomization. A computer software viz.
WINPEPI will be used for the randomization. The procedure allocation will be kept in a sealed opaque
envelops and they will be opened after written informed consent of eligible participants.
Pre-anaesthetic check-up will be carried out in all patients.
Using a sealed envelope technique, patients will be randomly assigned into two
groups
Group C: will receive Continuous Spinal Anaesthesia with Initial dose of 0.5% hyperbaric
BUPIVACAINE 10 mg (2 ml)
Group S: will receive Single Dose Spinal Anaesthesia with Total dose of 0.5% hyperbaric
BUPIVACAINE 18-19 mg (3.6-3.8 ml)
After arrival to procedure room, a peripheral I.V line, a blood pressure cuff and pulse oximetry probe
will be attached.
Pre-operative heart rate, systolic, diastolic, mean arterial pressure, and SpO2 will be recorded.
All patients will be co loaded with Ringer lactate solution 10ml/kg over 15 minutes.
Intraoperative monitoring, including continuous electrocardiogram, pulse oximetry, and Non-invasive
blood pressure, will be attached and baseline vitals noted
Following equipments will be required:
 A portable sterile tray containing:
 Sterile towel and gauze packs
 Sterile gloves
 Spirit
 Bowls containing povidone iodine
 Sterile syringes of 2ml, 5ml and 10 ml
 Sterile needle 18G, 20G and 24G
 Sterile 23G Quincke’s spinal needle
 Epidural catheter set (18 G Epidural Needle, 20 G Epidural Catheter)
 Local anaesthetic agent- Inj Bupivacaine 0.5% (Hyperbaric)
 Local anaesthetic agent- Inj Lignocaine 2 %
Under all aseptic precautions the skin was cleaned with an antiseptic solution.
After palpating a space at or below L3/L4, subcutaneous tissues and muscles are infiltrated with 2 ml of
LIGNOCAINE 2%.
The Tuohy needle (18 G) is then inserted until the resistance of the ligaments is felt. Thereafter the
needle is cautiously advanced, pausing every 0.5 cm to remove the stylet and check for CSF.
Once CSF is identified the needle should be occluded before inserting the catheter 3–4 cm into the
subarachnoid space.
To check the catheter, the end should be lowered below the level of insertion and a constant, steady
drip of CSF is observed. The catheter is then secured using an epidural dressing and the filter is
connected.
 Give 2 ml Hyperbaric Bupivacaine 0.5% (i.e; 10 mg)
with the patient in a supine position and check the block height after 5–10 min.
Further doses of 1 ml Hyperbaric Bupivacaine 0.5% can be injected every 5–10 min until the desired
block height is achieved.
Top up doses of Hyperbaric Bupivacaine 0.5% 0.8 ml can be given every hour to maintain the sensory
at T10.
Sensory and motor level will be evaluated by blind individual every 30 seconds for first 5 minutes, 1
minute till 10 minutes, every 5 minutes till 30 minutes and every 30 minutes till the end of surgery.
Sensory block will be checked bilaterally at mid-clavicular line using pinprick method.

 Intraoperative Hemodynamic Parameters
1. Mean Arterial Pressure (MAP)- measured every 2 minutes till first 10 minutes, Every 5 minutes
till first 10 minutes followed by every 15 minutes throughout the surgery.
2. Heart Rate (HR)- measured every 2 minutes till first 10 minutes, Every 5 minutes till first 10
minutes followed by every 15 minutes throughout the surgery.
3. Systolic Blood Pressure (SBP)- measured every 2 minutes till first 10 minutes, Every 5 minutes
till first 10 minutes followed by every 15 minutes throughout the surgery.
4. Diastolic Blood Pressure (DBP)-measured every 2 minutes till first 10 minutes, Every 5
minutes till first 10 minutes followed by every 15 minutes throughout the surgery.
5. Incidence of Hypotension- Decrease in MAP>20% from baseline
6. Incidence of Bradycardia- Decrease in HR >20% from baseline
7. Overall Incidence of Hemodynamic Instability- Decrease in MAP and HR >20% from baseline
8. Use of Vasopressors- Frequency and total dose
9. Use of Anticholinergics- Frequency and total dose
 
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