| CTRI Number |
CTRI/2025/02/080351 [Registered on: 12/02/2025] Trial Registered Prospectively |
| Last Modified On: |
27/12/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
To compare efficacy of sacral erector spinae plane block and wound infiltration in lower lumbar spine surgeries |
|
Scientific Title of Study
|
Comparative Efficacy of Ultrasound-Guided Sacral Erector Spinae Plane Block and Wound Infiltration in Transforaminal Lumbar Interbody Fusion: A Randomized Controlled Trial |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Sachin Kumar |
| Designation |
Assistant Professor |
| Affiliation |
All India Institute Of Medical Sciences,New Delhi |
| Address |
Room no-403 Surgical Block
4th Floor All India Institute Of Medical Sciences , Ansari Nagar New Delhi
South West
DELHI
110029
India |
| Phone |
9871549343 |
| Fax |
|
| Email |
docsachin.k@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Sachin Kumar |
| Designation |
Assistant Professor |
| Affiliation |
All India Institute Of Medical Sciences,New Delhi |
| Address |
Room no-403 Surgical Block
4th Floor All India Institute Of Medical Sciences , Ansari Nagar New Delhi
South West
DELHI
110029
India |
| Phone |
9871549343 |
| Fax |
|
| Email |
docsachin.k@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Sachin Kumar |
| Designation |
Assistant Professor |
| Affiliation |
All India Institute Of Medical Sciences,New Delhi |
| Address |
Room no-403 Surgical Block
4th Floor All India Institute Of Medical Sciences , Ansari Nagar New Delhi
South West
DELHI
110029
India |
| Phone |
9871549343 |
| Fax |
|
| Email |
docsachin.k@gmail.com |
|
|
Source of Monetary or Material Support
|
| Room no 403 4th Floor Surgical Block ALL INDIA INSTITUTE OF MEDICAL SCIENCES, NEW DELHI
Pin -110029 |
|
|
Primary Sponsor
|
| Name |
All India Institute Of Medical Sciences |
| Address |
Room No -403,4th Floor Surgical Block, ALL India Institute Of Medical Sciences, New Delhi Pin-110029 |
| 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 |
| Sachin Kumar |
Orthopedics Operation Theatre, ALL India Institute Of Medical Sciences |
All India Institute Of Medical Sciences, Ansari Nagar, New Delhi - 110029
New Delhi
DELHI |
9871549343
docsachin.k@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| All India Institute Of Medcal Sciences |
Submittted/Under Review |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O||Medical and Surgical, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Local anesthesia infiltration group |
After giving general anesthesia patient will be made prone and after completion of surgery equal volume of local anesthesia (as given in erector spinae plane block)will be infiltrated at incision site |
| Intervention |
Sacral Erector Spinae Plane block |
After giving general anesthesia to the patient the patient will be made prone and under ultrasound guidance sacral erector spinae plane block will be given bilaterally (20 ml of .25% ropivacaine) to the patient at S2 level. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
• Either Sex
• Age 18-70 years
• Patients scheduled for Trans-foraminal Lumbar Interbody Fusion (TLIF) surgery.
|
|
| ExclusionCriteria |
| Details |
• Patient with coagulopathy
• Patient allergic to local anaesthetic
• Chronic opioid dependence or use of painkillers for more than 3 months
• Inability to communicate due to severe dementia, language barrier, or end-stage disease
• Comorbidity of the central and/or peripheral nervous system
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| . To compare the postoperative opioid consumption between sacral ESP block and Wound Infiltration in patients undergoing TLIF surgeries under general anaesthesia. |
30 min., 1 hr,2,4,8,12,24 hr postopeartively |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
. To compare total intraoperative fentanyl requirement between the two groups.
2. To compare the time to first rescue analgesia requirement in the post-operative period between the two groups
3. To compare postoperative pain at rest as assessed by Numeric Rating Scale in both groups at 30mins, 1hour, 2 hours, 4 hours, 8 hours, 12 hours and 24 hours postoperatively.
4. To compare incidence of PONV in both groups at 30mins, 1hour, 2 hours, 4 hours, 8 hours, 12 hours and 24 hours postoperatively
|
30 min., 1 hr, 2,4,8,12,24 hr postopeartively |
|
|
Target Sample Size
|
Total Sample Size="62"
Sample Size from India="62"
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)
|
01/04/2025 |
| 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="1"
Months="1"
Days="1" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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 - NO
|
|
Brief Summary
|
Transforaminal Lumbar interbody Fusion surgery (TLIF) is a
surgery indicated in degenerative disc disease, spinal stenosis,
spondylolisthesis, low back pain with sciatica symptoms and facet joint
pain.Adequate analegia post surgery becomes important in these patients for
early rehabilitation. Incision site infiltration with local anesthetics is
commonly used in these patients. A novel technique of injection of local
anaesthetic at sacrum S2 level has been found to be effective in anorectal
surgery. Recently in a dye study lower lumbar spread of the dye has been found.
With this knowledge we have planned a RCT comparing Sacral ESP and local wound
infiltration in patient undergoing TLIF Surgery from any level from L1 to L5
for postoperative pain.
|