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CTRI Number  CTRI/2026/01/100844 [Registered on: 12/01/2026] Trial Registered Prospectively
Last Modified On: 09/01/2026
Post Graduate Thesis  No 
Type of Trial  Observational 
Type of Study   Follow Up Study 
Study Design  Non-randomized, Multiple Arm Trial 
Public Title of Study   Morbidity and mortality after lower limb surgeries 
Scientific Title of Study   Outcomes (morbidities and mortality) after long bone lower limb surgeries: A prospective comparison of spinal versus general anaesthesia 
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 Geeta Singariya 
Designation  Senior Professor 
Affiliation  Dr SN Medical Collage Jodhpur 
Address  124 Vaishali Avenue Opposite B R Birla public School Jhanwar Road Jodhpur Rajasthan
Shastri Circle Dr SN Medical Collage Jodhpur Rajasthan
Jodhpur
RAJASTHAN
342008
India 
Phone  09414803554  
Fax    
Email  geetamanojkamal@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Geeta Singariya 
Designation  Senior Professor 
Affiliation  Dr SN Medical Collage Jodhpur 
Address  124 Vaishali Avenue Opposite B R Birla public School Jhanwar Road Jodhpur Rajasthan
Shastri Circle Dr SN Medical Collage Jodhpur Rajasthan

RAJASTHAN
342008
India 
Phone  09414803554  
Fax    
Email  geetamanojkamal@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Abhas Chhabra 
Designation  Medical Officer 
Affiliation  Dr SN Medical Collage Jodhpur 
Address  Dr SN Medical Collage Jodhpur Rajasthan
Shastri Circle Dr SN Medical Collage Jodhpur Rajasthan
Jodhpur
RAJASTHAN
342001
India 
Phone  9829113292  
Fax    
Email  abhas.chh@gmail.com  
 
Source of Monetary or Material Support  
MDM Hospital Dr SN Medical College Jodhpur RAJASTHAN 342001 India  
 
Primary Sponsor  
Name  M D M Hospital Dr S N Medical College Jodhpur  
Address  Operation theater MDM Hospital Dr SN Medical College Shastri Nagar Jodhpur Rajasthan 342001  
Type of Sponsor  Government 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 GEETA SINGARIYA  MDM hospital Dr S N Medical Collage Jodhpur  Mathura Das Mathur Hospital Department of Anaesthesia Orthopedic Operation theater First Floor Dr SN Medical Collage Jodhpur
Jodhpur
RAJASTHAN 
09414803554

geetamanojkamal@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee Dr SN Medical College Jodhpur  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: M968||Other intraoperative and postprocedural complications and disorders of musculoskeletal system, not elsewhere classified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Observation study  Observation study 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  80.00 Year(s)
Gender  Both 
Details  ASA physical status I to IV
Patients undergoing elective and emergency long-bone lower limb surgeries either spinal anaesthesia or general anaesthesia
 
 
ExclusionCriteria 
Details  Patients who refuse to participate
Patients with known allergy to anaesthetic drugs
Pre existing neurological deficits
Patients with any history of acute illness  
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Comparison of the thromboembolic events among the patients undergoing lower limb surgery either under spinal anaesthesia or general anaesthesia  Upto 30 days after surgery 
 
Secondary Outcome  
Outcome  TimePoints 
Incidence of intraoperative complication
Incidence of postoperative complications
Postoperative recovery profiles (time to mobilization, time to first oral intake, time to return of bladder function)
To compare the postoperative incidence of re intubation and ICU admission
Length of hospital stay.
To compare the 30-day readmission rate
Mortality rate within 30 day follow up period
 
Up to 30 days after surgery 
 
Target Sample Size   Total Sample Size="1200"
Sample Size from India="1200" 
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)   30/01/2026 
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="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 - YES
  1. What data in particular will be shared?
    Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    Response -  Statistical Analysis Plan
    Response - Informed Consent Form

  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 [geetamanojkamal@gmail.com].

  6. For how long will this data be available start date provided 31-12-2026 and end date provided 31-12-2030?
    Response - Beginning 9 months and ending 36 months following article publication.

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

This prospective observational comparative study will be conducted to evaluate differences in postoperative morbidity and mortality between patients receiving spinal anaesthesia and those receiving general anaesthesia for long bone lower limb surgeries.

To ensure inclusion in the study, each patient will be subjected to a detailed pre-anaesthetic evaluation on the basis of a detailed history from the patient and thorough physical examination as well as pre-anaesthetic airway assessment (mouth opening, thyromental distance, Mallampati grade, dentition, etc) will be done. Basic demographic data like name, age, sex, height, and body weight for BMI will be recorded. Complete general physical examination, BMI check, investigations and ASA grading will be done. In all the patients, baseline investigations will be done to rule out any abnormalities. The purpose and detailed procedure and visual analogue scale (VAS) will be explained to the patients. Written informed consent will be taken from all the patients about the procedure. All patients will be kept nil by mouth as per standard guidelines before the scheduled time of surgery.  After a complete pre-anaesthetic evaluation, patients will be taken into the operation theatre and standard ASA monitoring parameters like SPO2, blood pressure, ECG, EtCO2, etc. will be attached. After the decision for the type of anaesthesia (according to the patient’s consent and associated co-morbidities of patients) will be taken by the anaesthesiologist involved in the patient’s management during surgery. The anaesthesia (spinal anaesthesia or general anaesthesia) will be given to patients according to the needs of the patient and as per institutional guidelines. All the patients will be monitored during the perioperative period as per protocol and will be followed up for 30 days after the surgery.

 
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