| 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
|
|
|
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
|
|
|
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
- 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).
- What additional supporting information will be shared?
Response - Study Protocol Response - Statistical Analysis Plan Response - Informed Consent Form
- 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.
- For what types of analyses will this data be available?
Response - For individual participant data meta-analysis.
- By what mechanism will data be made available?
Response - Proposals should be directed to [geetamanojkamal@gmail.com].
- 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.
- 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. |