| CTRI Number |
CTRI/2025/04/084026 [Registered on: 03/04/2025] Trial Registered Prospectively |
| Last Modified On: |
29/03/2025 |
| 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
|
A clinical Trial to Assess the Efficacy of Enhanced Recovery After Surgery (ERAS) protocol in recovery of patients undergoing Elective Lumbar Spinal fusion |
|
Scientific Title of Study
|
A Randomised Controlled Trial to Assess the Efficacy of Enhanced Recovery After Surgery (ERAS) protocol in Elective Lumbar Spinal fusion |
| Trial Acronym |
ERAS |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
MUMMAKA SIVA PRASAD |
| Designation |
senior resident |
| Affiliation |
SVIMS , TIRUPATI, INDIA |
| Address |
Department of Neurosurgery, SVIMS. Tirupati.
Chittoor
ANDHRA PRADESH
517507
India |
| Phone |
08317609601 |
| Fax |
|
| Email |
sivamsp143@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
MUMMAKA SIVA PRASAD |
| Designation |
senior resident |
| Affiliation |
SVIMS , TIRUPATI, INDIA |
| Address |
room no 201 , second floor , padmavathi block ,Department of Neurosurgery,Sri Venkateswara Institute of Medical Sciences - SVIMS. Tirupati.
Chittoor
ANDHRA PRADESH
517507
India |
| Phone |
08317609601 |
| Fax |
|
| Email |
sivamsp143@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
MUMMAKA SIVA PRASAD |
| Designation |
senior resident |
| Affiliation |
SVIMS , TIRUPATI, INDIA |
| Address |
Department of Neurosurgery, SVIMS. Tirupati.
Chittoor
ANDHRA PRADESH
517507
India |
| Phone |
08317609601 |
| Fax |
|
| Email |
sivamsp143@gmail.com |
|
|
Source of Monetary or Material Support
|
| Sri Venkateswara Institute of Medical Sciences |
|
|
Primary Sponsor
|
| Name |
Dr M Siva Prasad |
| Address |
Senior Resident , Department of Neurosurgery, Sri Venkateswara Institute of Medical Sciences, Tirupati , 517507 |
| Type of Sponsor |
Other [SELF] |
|
|
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 M Siva Prasad |
Sri Venkateswara Institute of Medical Sciences SVIMS |
room no 201 , second floor , padmavathi block ,Department of Neurosurgery,Sri Venkateswara Institute of Medical Sciences - SVIMS. Tirupati.
Chittoor
ANDHRA PRADESH |
8317609601
sivamsp143@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Sri Venkateswara Institute of Medical Sciences,Institutional Ethics Committee |
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 |
| Intervention |
Enhanced Recovery After Surgery ERAS protocol in Elective Lumbar Spinal fusion |
Patients undergoing elective lumbar spinal fusion will receive perioperative care based on the Enhanced Recovery After Surgery (ERAS) protocol. The ERAS protocol includes:
Preoperative Care:
Patient counseling and education
Carbohydrate loading (except in diabetics)
No prolonged fasting (clear fluids up to 2 hours before surgery)
Preoperative multimodal analgesia
Intraoperative Care:
Goal-directed fluid therapy
Multimodal opioid-sparing analgesia
Normothermia maintenance
Minimally invasive surgical techniques where applicable
Postoperative Care:
Early oral intake and removal of IV fluids
Early mobilization (within 24 hours)
Multimodal pain management (including regional anesthesia techniques)
Early urinary catheter removal
Reduced opioid use
Discharge planning and follow-up |
| Comparator Agent |
Traditional Group undergoing Elective Lumbar Spinal fusion |
Patients undergoing elective lumbar spinal fusion will receive traditional perioperative care, which includes:
Preoperative Care:
Standard fasting guidelines (nil per oral after midnight)
No specific carbohydrate loading
Routine preoperative counseling
Intraoperative Care:
Standard fluid management
Conventional opioid-based analgesia
Routine temperature monitoring
Standard surgical approach
Postoperative Care:
Delayed oral intake (gradual diet progression)
Standard pain control (opioid-based)
Delayed mobilization (typically after 48 hours)
Prolonged urinary catheterization
Standard discharge criteria |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
1)Age greater than 18 years
2) Undergoing elective lumbar spinal fusion |
|
| ExclusionCriteria |
| Details |
1)Patients not consenting for the study.
2)Patients undergoing urgent or emergent surgery.
3)Vulnerable patients such as pregnant women.
4)Infective spine pathology, tumours. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Length of hospital stay |
2 years |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Assessment of pain control in the hospital using Visual Analogue Scale (VAS) pain scores before surgery, at discharge, and average daily scores. |
2 years |
| Total postoperative analgesic consumption during hospitalization and patient-reported analgesic usage one month post-surgery. |
2 years |
| Postoperative mobilization and ambulation in the hospital, including time to ambulation and incidence of hospital falls. Mobilization refers to extremity movement and ambulation denotes walking with or without assistance. |
2 years |
| Utilization and duration of Foley catheterization, as well as the need for postoperative straight catheterization. |
2 years |
| Assessment of inflammatory markers. |
2 years |
|
|
Target Sample Size
|
Total Sample Size="70"
Sample Size from India="70"
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)
|
20/04/2025 |
| 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) |
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
Response - Clinical Study Report
Response - Analytic Code
- Who will be able to view these files?
Response - Researchers who provide a methodologically sound proposal.
- For what types of analyses will this data be available?
Response - To achieve aims in the approved proposal.
- By what mechanism will data be made available?
Response - Proposals should be directed to [sivamsp143@gmail.com].
- For how long will this data be available start date provided 01-01-2030 and end date provided 01-01-2031?
Response - Beginning 3 months and ending 5 years following article publication.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
|
|
Brief Summary
|
This prospective randomized controlled trial aims to compare Enhanced Recovery After Surgery (ERAS) with traditional perioperative care in elective lumbar spinal fusion patients. The primary outcome is the length of hospital stay (LOS), while secondary outcomes include pain control, analgesic use, mobilization, catheterization, and inflammatory markers. Patients will be stratified and randomized into two groups, with follow-ups at 72 hours, 4-6 weeks, and 3 months postoperatively. The study will enroll 70 patients (35 per group) and analyze data using SPSS v22, with significance set at p<0.05. Ethical clearance has been obtained, and patient confidentiality will be maintained. |