| CTRI Number |
CTRI/2025/12/099018 [Registered on: 12/12/2025] Trial Registered Prospectively |
| Last Modified On: |
12/12/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Prospective |
| Study Design |
Other |
|
Public Title of Study
|
How Quickly Patients Begin Moving After Major Spine Surgery: A Patient-Focused Study |
|
Scientific Title of Study
|
Extubation-to-Mobilisation Interval in Major Spine Surgery: A Prospective Study |
| 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 Shivanand Mayi |
| Designation |
Principal Investigator and Spine Surgeon |
| Affiliation |
Stavya Spine Hospital And Research Institute |
| Address |
2nd floor , Research Department , Stavya Spine Hospital and Research institute , Near Nagri Hospital , Mithakhali , Ellisbridge , Ahmedabad - 380006,Gujarat,India.
Stavya Spine hospital and Research Institute Ellisbridge Mithakhali
Ahmadabad
GUJARAT
380006
India |
| Phone |
09825019913 |
| Fax |
|
| Email |
drshivanandmayi@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Shivanand Mayi |
| Designation |
Principal Investigator and Spine Surgeon |
| Affiliation |
Stavya Spine Hospital And Research Institute |
| Address |
2nd floor , Research Department , Stavya Spine Hospital and Research institute , Near Nagri Hospital , Mithakhali , Ellisbridge , Ahmedabad - 380006,Gujarat,India.
Stavya Spine hospital and Research Institute Ellisbridge Mithakhali
GUJARAT
380006
India |
| Phone |
09825019913 |
| Fax |
|
| Email |
drshivanandmayi@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Shivanand Mayi |
| Designation |
Principal Investigator and Spine Surgeon |
| Affiliation |
Stavya Spine Hospital And Research Institute |
| Address |
2nd floor , Research Department , Stavya Spine Hospital and Research institute , Near Nagri Hospital , Mithakhali , Ellisbridge , Ahmedabad - 380006,Gujarat,India.
Stavya Spine hospital and Research Institute Ellisbridge Mithakhali
GUJARAT
380006
India |
| Phone |
09825019913 |
| Fax |
|
| Email |
drshivanandmayi@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Stavya Spine Hospital and Research Institute |
| Address |
2nd floor, Research Department ,Stavya Spine hospital and Research Institute, Ellisbridge ,Mithakhali,Ahmadabad,GUJARAT,380006,India |
| Type of Sponsor |
Research institution and hospital |
|
|
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 Shivanand Mayi |
Stavya Spine Hospital & Research Institute |
2nd floor , Research Department , Stavya Spine Hospital and Research institute , Near Nagri Hospital , Mithakhali , Ellisbridge , Ahmedabad - 380006,GUJARAT,
India
Ahmadabad
GUJARAT |
94497822029
drshivanandmayi@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Stavya Spine hospital & Research Institute IEC |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M47||Spondylosis, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
| Comparator Agent |
NIL. |
NIL. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
1. Adults undergoing planned major spine surgery (multi-level fusion, instrumentation, complex decompression)
2. Ability to walk preoperatively
|
|
| ExclusionCriteria |
| Details |
1. Preexisting immobility or severe neurological deficits
2. Acute infection, malignancy, or trauma cases
3. Severe comorbidities (cardiac or respiratory) that preclude safe mobilisation
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
1. Interval (hours) from extubation to first mobilisation (out-of-bed ambulation).
2. Rate of successful early mobilisation (able to mobilize within 24 hours post-extubation).
3. Functional status at discharge (ODI score)
4. Postoperative pain scores (e.g., visual analogue scale).
|
Pre Operative visit,Post Operative visit and Day 1 visit is required. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL. |
NIL. |
|
|
Target Sample Size
|
Total Sample Size="200"
Sample Size from India="200"
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)
|
26/12/2025 |
| 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="2"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
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
|
This prospective observational study aims to evaluate the interval between extubation and first mobilisation in adult patients undergoing major spine surgery, including laminectomy, discectomy, and spinal fusion. Early mobilisation is an important part of enhanced recovery after spine surgery, yet limited evidence exists on how the time from extubation to mobilisation influences postoperative outcomes. The study will assess mobilisation timing and its association with pain scores, functional recovery, complications, and length of hospital stay.
Preoperative data will include patient demographics, baseline Oswestry Disability Index (ODI), VAS pain scores, comorbidities, and surgical indications. Intraoperative data will include procedure type, operative duration, blood loss, levels operated, anesthesia details, and intraoperative complications. Postoperative data will capture exact mobilisation timing, serial VAS scores, analgesic use, ODI at discharge, hospital stay duration, and postoperative complications including infection, DVT, neurological deficits, reoperation, or readmission.
Findings from this study may help strengthen perioperative management and early rehabilitation protocols for major spine surgery. |