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CTRI Number  CTRI/2025/08/093494 [Registered on: 22/08/2025] Trial Registered Prospectively
Last Modified On: 22/08/2025
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Drug
Surgical/Anesthesia 
Study Design  Non-randomized, Multiple Arm Trial 
Public Title of Study   Regional anaesthesia with three different drug doses in sick and elderly patients with hip fracture 
Scientific Title of Study   Anaesthetic management of high risk orthopedic patients with combined sequential spinal epidural using three different doses of intrathecal ropivacaine 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Sathyasuba Meenakshi sundaram 
Designation  Associate Professor 
Affiliation  BIHER 
Address  #7, CLC Works road, Sree Balaji medical college and hospital, Chromepet, Chennai 600044.
OR 10, Green star OT complex, 3rd floor, Dept. of Anaesthesia, SBMCH, Chennai 600044
Chennai
TAMIL NADU
600044
India 
Phone  9791421124  
Fax    
Email  drsathyasuba@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Sathyasuba Meenakshi sundaram 
Designation  Associate Professor 
Affiliation  BIHER 
Address  #7, CLC Works road, Sree Balaji medical college and hospital, Chromepet, Chennai 600044.
OR 10, Green star OT complex, 3rd floor, Dept. of Anaesthesia, SBMCH, Chennai 600044.
Chennai
TAMIL NADU
600044
India 
Phone  9791421124  
Fax    
Email  drsathyasuba@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Sathyasuba Meenakshi sundaram 
Designation  Associate Professor 
Affiliation  BIHER 
Address  #7, CLC Works road, Sree Balaji medical college and hospital, Chromepet, Chennai 600044.
OR 10, Green star OT complex, 3rd floor, Dept. of Anaesthesia, SBMCH, Chennai 600044
Chennai
TAMIL NADU
600044
India 
Phone  9791421124  
Fax    
Email  drsathyasuba@gmail.com  
 
Source of Monetary or Material Support  
SREE BALAJI MEDICAL COLLEGE AND HOSPITAL CHROMPET, CHENNAI-44 
 
Primary Sponsor  
Name  NIL 
Address  NIL 
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 
Sathyasuba Meenakshi sundaram  Sree Balaji medical college and hospital  OR No.10, Green star OT complex, 3rd floor, Dept of Anaesthesia, Sree Balaji medical college and hospital, Chromepet, Chennai 600044
Chennai
TAMIL NADU 
09791421124

drsathyasuba@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
IHEC-SBMCH  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: M00-M99||Diseases of the musculoskeletal system and connective tissue, (2) ICD-10 Condition: M80||Osteoporosis with current pathological fracture, (3) ICD-10 Condition: M800||Age-related osteoporosis with current pathological fracture, (4) ICD-10 Condition: M800||Age-related osteoporosis with current pathological fracture, (5) ICD-10 Condition: O||Medical and Surgical,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Combined sequential spinal epidural anaesthesia   Comparator 1 SAB with three and a half mg of ropivacaine heavy and epidural top up with half percent bupivacaine  
Comparator Agent  Combined sequential spinal epidural anaesthesia  Comparator 2 SAB with five mg of ropivacaine heavy and epidural top up with half percent bupivacaine 
Comparator Agent  Combined sequential spinal epidural anaesthesia  Comparator 3 SAB with seven point five mg of ropivacaine heavy and epidural top up with half percent bupivacaine 
Intervention  SAB with different doses of spinal ropivacaine   SAB with three and a half mg five mg and seven and a half mg of ropivacaine  
 
Inclusion Criteria  
Age From  65.00 Year(s)
Age To  95.00 Year(s)
Gender  Both 
Details  1.Patients with ASA III & above
2.Heart disease with systolic & diastolic dysfunction
3.IHD with no indication/unwilling for pre-procedure intervention
4.Patients of either sex above 75 yrs of age irrespective of other comorbidities
5.Patients of uncontrolled DM
6.Elective /emergency surgery
 
 
ExclusionCriteria 
Details  1.Patients <65 yrs
2.Contraindication of CSEA/SAB
3.Not willing 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant and Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
The primary objective is to compare the hemodynamic stability measured in terms of fall in MAP 30% from baseline.  Every 5 minutes, upto 30 minutes and then every 15 minutes till completion of surgery. 
 
Secondary Outcome  
Outcome  TimePoints 
1. Incidence of bradycardia
2. Time needed to achieve bromage 3 (complete motor paralysis)
3. Time needed to reach sensory T10
4. Volume of epidural bupivacaine to reach sensory T10
5. Surgeon satisfaction
6. Patient satisfaction
7. Adverse events if any
 
Whenever incidences are noticed from start of anaesthesia till completion of surgery 
 
Target Sample Size   Total Sample Size="60"
Sample Size from India="60" 
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)   15/09/2025 
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="0"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)   Closed to Recruitment of Participants 
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 - YES
  1. What data in particular will be shared?
    Response - All of the individual participant data collected during the trial, after de-identification.

  2. What additional supporting information will be shared?
    Response -  Study Protocol

  3. Who will be able to view these files?
    Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.

  4. For what types of analyses will this data be available?
    Response - For individual participant data meta-analysis.

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [drsathyasuba@gmail.com].

  6. For how long will this data be available start date provided 20-09-2025 and end date provided 02-09-2026?
    Response - Beginning 3 months and ending 5 years following article publication.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
Brief Summary  

Patients will be observed in terms of 3 groups namely Group 1 SAB with three and a half mg of ropivacaine heavy and epidural top up with half percent bupivacaine till T10 level is achieved Group 2 SAB with five mg of ropivacaine heavy and epidural top up with half percent bupivacaine till T10 level is achieved Group 3 SAB with seven and a half mg of ropivacaine heavy and epidural top up with half percent bupivacaine till T10 level is achieved After 2 segment regression epidural top ups will be given with bupivacaine half percent either one third  of the dose needed to achieve T10 level or 3 ml. The level of sensory block, modified Bromage motor scores MBS systolic blood pressure MAP and heart rate will be recorded for 30 min following anesthesia Peak sensory block height and MBS time for sensory regression to L1 and motor recovery to MBS 1 side effects and operator s satisfaction will be noted.Dural puncture will be performed at the L3 4 interspace with a 25 gauge Quincke tip spinal needle Next 0 5 percent hyperbaric ropivacaine will be given intrathecally in doses of 7 5 mg  11 25 mg and 15 mg in 3 groups namely groups 1 2 and 3 after the free flow of cerebrospinal fluid is observed The degree of sensory and motor block will be measured on the unoperated side of the limbs Surgery will be allowed to start as soon as the sensory block height reached the tenth thoracic dermatome T10 or 10 min had elapsed After 2 segment regression epidural top ups with bupivacaine 0 5 percent either 1/3 of the dose needed to achieve T10 level or 3 ml will be given,for the completion of surgery The orthopedic surgeons performing all the operations will grade the operator s satisfaction on a 5 point scale 5  very good 4  good 3  satisfactory 2 poor 1 very poor Similarly patient satisfaction will be noted down on a five point Likert scale Very satisfied Satisfied  Neither satisfied nor dissatisfied Dissatisfied and Very dissatisfied from a scale of 5 to 1

 

 

 

 

 

 

 
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