| CTRI Number |
CTRI/2024/08/072809 [Registered on: 21/08/2024] Trial Registered Prospectively |
| Last Modified On: |
01/09/2025 |
| 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
|
Analgesic Efficacy of Ultrasound Guided Sacral
Erector Spinae Block for Paediatric Patients
Undergoing Lower Limb Orthopaedic Surgery |
|
Scientific Title of Study
|
Comparison of Analgesic Efficacy of Ultrasound Guided Sacral Erector Spinae Block vs Caudal Block for Paediatric Patients Undergoing Lower Limb Orthopaedic Surgery: A Randomised 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 |
Vikram Chandra |
| Designation |
Senior Resident |
| Affiliation |
AIIMS, patna |
| Address |
All India institue of medical sciences, patna, Bihar
Patna BIHAR 801507 India |
| Phone |
9661681476 |
| Fax |
|
| Email |
vikram93chandra@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Chandni sinha |
| Designation |
professor |
| Affiliation |
AIIMS, patna |
| Address |
All India institue of medical sciences, patna, Bihar
Patna BIHAR 801507 India |
| Phone |
7250333148 |
| Fax |
|
| Email |
chandni.doc@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Vikram Chandra |
| Designation |
Senior Resident |
| Affiliation |
AIIMS, patna |
| Address |
All India institue of medical sciences, patna, Bihar
Patna BIHAR 801507 India |
| Phone |
9661681476 |
| Fax |
|
| Email |
vikram93chandra@gmail.com |
|
|
Source of Monetary or Material Support
|
| All India Institute of medical sciences,Phulwarisharif, Patna, Bihar-801507 |
|
|
Primary Sponsor
|
| Name |
AIIMS Patna |
| Address |
All India institute of medical sciences, Phulwarisharif, Patna, Bihar-801507 |
| 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 Vikram Chandra |
All India institute of medical sciences, patna |
6th floor OT complex , Department of Anaesthesiology Patna BIHAR |
9661681476
vikram93chandra@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| institutional ethics committee, All India institute of medical sciences, Patna |
Approved |
|
|
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 |
Caudal block |
Caudal block with 1ml per kg body weight with 0.2 percent ropivacaine. Will assess pain score till 24-hour postoperative period |
| Intervention |
SACRAL ERECTOR SPINAE BLOCK |
Ultrasound-guided Sacral ESP block with 1ml per kg body weight with 0.2 percent ropivacaine. Will assess pain score till 24-hour postoperative period |
|
|
Inclusion Criteria
|
| Age From |
1.00 Year(s) |
| Age To |
8.00 Year(s) |
| Gender |
Both |
| Details |
1. Age 1-8 years
2. ASA I and II patients scheduled for unilateral lower limb orthopaedic surgery |
|
| ExclusionCriteria |
| Details |
1. Parent refusal to participate in the study.
2. Patients with coagulation disorders.
3. Patients hypersensitive to study medications.
4. Patients with developmental or mental delay.
5. Skin lesions or infection at the planned site of needle insertion
6. Congenital vertebral anomalies |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
To compare time to first rescue analgesia in sacral ESP block with caudal epidural block
in paediatric lower limb orthopaedic surgery. |
at 30 minutes,2,4,6,8,12
and 24 hours |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. To compare postoperative pain scores using the FLACC scale at 30 minutes,2,4,6,8,12
and 24 hours
2. To compare postoperative rescue analgesia consumption
3. To compare side effects like nausea, vomiting & lower limb weakness |
30 minutes,2,4,6,8,12 & 24 hours posoperatively |
|
|
Target Sample Size
|
Total Sample Size="70" Sample Size from India="70"
Final Enrollment numbers achieved (Total)= "70"
Final Enrollment numbers achieved (India)="70" |
|
Phase of Trial
|
Phase 3 |
|
Date of First Enrollment (India)
|
01/09/2024 |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1" Months="0" Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
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 - All of the individual participant data collected during the trial, after de-identiļ¬cation.
- 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 - Anyone
- 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 (Others) -
- For how long will this data be available start date provided 22-07-2025 and end date provided 22-07-2028?
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
|
The erector spinae plane block (ESPB) is an interfascial plane block, which appears to be increasing in popularity. Introduced in 2016, primarily to alleviate thoracic neuropathic pain, the indications for the block have been expanding since then.In pediatric surgery, caudal block is a low-cost, simple, and effective procedure for postoperative analgesia and as the only anaesthetic strategy . Caudal block is recommended for most surgical operations in the lower body, primarily below the umbilicus, including lower limb surgeries, inguinal hernia repair, urinary and digestive system surgery. Lower limb is supplied from nerve terminals arising from both sacral (sciatic L4-S3) and lumber (femoral (L2-L4) plexus. Erector spinae muscles overlay on the sacral lamina and continue over the transverse processes of lumbar vertebrae, thus a sacral ESP block performed with an adequate volume will spread in interfacial plane and through sacral foramina blocking both femoral and sciatic nerve, thus providing adequate analgesia for paediatric lower limb surgeries. Caudal block has been successfully used as a part of multimodal analgesic regime in surgeries in paediatric patients. There is a lack of comprehensive research on Sacral erector spinae block in paediatric patients. Effectiveness of sacral ESPB determined by our study will add to the existing body of scientific literature supporting its use as analgesic technique in current practice.No randomised controlled trial has been conducted till date comparing sacral ESPB block to caudal block in paediatric patients. We expect that sacral ESP block will provide analgesia noninferior to caudal block in paediatric patients undergoing lower limb surgeries. |