CTRI Number |
CTRI/2025/04/084203 [Registered on: 07/04/2025] Trial Registered Prospectively |
Last Modified On: |
04/04/2025 |
Post Graduate Thesis |
Yes |
Type of Trial |
Interventional |
Type of Study
|
Surgical/Anesthesia |
Study Design |
Randomized, Parallel Group Trial |
Public Title of Study
|
Comparative Analysis of Ultrasound-Guided Sacral Erector Spinae Plane Block and Caudal Epidural Block for pain relief Efficacy in Pediatric Lower Limb Surgery |
Scientific Title of Study
|
Comparison of the analgesic efficacy of ultrasound guided Sacral Erector Spinae Plane Block with ultrasound guided Caudal epidural Block in paediatric patients undergoing lower limb surgery under general anaesthesia: a randomised controlled 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 Nishant Varlani |
Designation |
Junior Resident |
Affiliation |
AIIMS Bhopal |
Address |
Department of Anesthesia and critical care,3rd floor hospital building, AIIMS Bhopal, Saket Nagar Bhopal Madhya Pradesh 462020
India
Bhopal MADHYA PRADESH 462020 India |
Phone |
7793066644 |
Fax |
|
Email |
nsvarlani@gmail.com |
|
Details of Contact Person Scientific Query
|
Name |
Dr Zainab Ahmed |
Designation |
Additional Professor |
Affiliation |
AIIMS Bhopal |
Address |
Department of Anesthesia and critical care,3rd floor hospital
building,AIIMS Bhopal,Saket Nagar Bhopal Madhya Pradesh 462020
India
Bhopal
MADHYA PRADESH
462020
India
Bhopal MADHYA PRADESH 462020 India |
Phone |
8860048951 |
Fax |
|
Email |
drzainabhaq@gmail.com |
|
Details of Contact Person Public Query
|
Name |
Dr Zainab Ahmed |
Designation |
Additional Professor |
Affiliation |
AIIMS Bhopal |
Address |
Department of Anesthesia and critical care,3rd floor hospital
building,AIIMS Bhopal,Saket Nagar Bhopal Madhya Pradesh 462020
India
Bhopal
MADHYA PRADESH
462020
India
MADHYA PRADESH 462020 India |
Phone |
8860048951 |
Fax |
|
Email |
drzainabhaq@gmail.com |
|
Source of Monetary or Material Support
|
ALL INDIA INSTITUTE OF MEDICAL SCIENCES, Saket Nagar, Bhopal Madhya pradesh India 462020 |
|
Primary Sponsor
|
Name |
Dr Zainab Ahmed |
Address |
Department of Anesthesia and critical care,3rd floor hospital building, AIIMS Bhopal, Saket Nagar Bhopal Madhya Pradesh 462020
India |
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 Nishant Varlani |
AIIMS Bhopal |
AIIMS Bhopal, Saket Nagar Bhopal Madhya Pradesh 462020
India Bhopal MADHYA PRADESH |
07793066644
nsvarlani@gmail.com |
|
Details of Ethics Committee
|
No of Ethics Committees= 1 |
Name of Committee |
Approval Status |
AIIMS Bhopal Instittutional Human Ethics Committee-Student Research(IHEC-SR |
Approved |
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
|
Health Type |
Condition |
Patients |
(1) ICD-10 Condition: 8||Other Procedures, |
|
Intervention / Comparator Agent
|
Type |
Name |
Details |
Comparator Agent |
Caudal Epidural Block. |
After inducing the ptient under general anesthesia, before the incision, local anesthetic will be injected in caudal epidural space in a dose of 0.25% Bupivacaine 1 ml/kg subject to a maximum dose of 2.5 mg/kg of Bupivacaine with 2mcg/kg clonidine. It will take around 10 mins. exact time will be noted. |
Intervention |
Sacral Erector Spinae Plane Block |
After inducing the patient under general anesthesia, before the incision, local anesthetic will be injected in sacral erector spinae plane in a dose 1ml/kg of 0.25% Bupivacaine subject to a maximum dose of 2.5 mg/kg of Bupivacaine + Clonidine 2 micrograms/kg. It will take around 10 mins. exact time will be noted |
|
Inclusion Criteria
|
Age From |
1.00 Year(s) |
Age To |
9.00 Year(s) |
Gender |
Both |
Details |
The study will include all paediatric patients of age 1 years - 9 years, of either sex, ASA(American Society of Anesthesiologists classification of Physical Status) grade I and II undergoing elective or emergency lower limb surgery whose plan of anesthesia is decided as general anesthesia with a regional anesthesia technique. |
|
ExclusionCriteria |
Details |
1.Contraindications to regional technique e.g. allergy to local anesthetic drugs, local site infection, sepsis, coagulation disturbance, anatomical abnormalities etc
2.Infants ( because of challenging blocks in this age group).
3.More than 9 years of age (due to the anatomical difficulties expected during caudal epidural block because of progressive ossification of sacrococcygeal ligament making the identification of the sacral hiatus difficult.)
4.Patient with neurological disorders
5.Patient with cutaneous anomalies (angioma, hair tuft, naevus , dimple at the site of block)
6.Inability to identify landmarks.
7.Patients on anti-epileptic drugs or any other enzyme inducers as that would affect the metabolism of the drug.
8.Hypersensitivity/contra-indication to any of the study drugs- local anesthetic or analgesic
9.Patients with polytrauma and patients with fractures of both upper and lower limb. |
|
Method of Generating Random Sequence
|
Computer generated randomization |
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
Blinding/Masking
|
Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded |
Primary Outcome
|
Outcome |
TimePoints |
Duration of post-operative analgesia is defined as the time after surgery within the first 24 hours at which Face, Leg, Activity, Cry and Consolability score (FLACC score) (a validated pain score) more than 4 or a verbal request of analgesics from verbal children. |
T0 0 hour
T1 1 hour
T2 2 hours
T3 6 hours
T4 12 hours
T5 24 hours |
|
Secondary Outcome
|
Outcome |
TimePoints |
1.To assess & compare intraoperative opioid requirement in both the groups defined as total number of doses of fentanyl required.
2.To determine & compare the number & cumulative doses of rescue analgesics in the first 24 hours postoperatively.
3.To determine the fraction of patients requiring rescue analgesics within the first 24 hours postoperatively.
4.To determine Parental Satisfaction Score in both groups at postoperative day 1 (POD1). |
0 hour, 1hour, 2hours, 6hours, 24 hours |
|
Target Sample Size
|
Total Sample Size="54" Sample Size from India="54"
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
|
Phase 4 |
Date of First Enrollment (India)
|
15/04/2025 |
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="6" 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 - NO
|
Brief Summary
|
Regional anesthesia is now recommended as an adjunct to general anesthesia whenever feasible for its opioid and anesthetic sparing effect. Caudal epidural block (CEB) is one of the most routinely practiced regional anesthetic procedures for intra and post-operative analgesia in paediatric patients. Although complications are rare, adverse effects reported include intravascular, subarachnoid or intraosseous space injection, hypotension (more common in adults), epidural hematoma as well as urinary retention. USG-guided ESPB is now a common regional anesthetic technique used in clinical practice for a variety of indications including breast reconstruction surgeries, lumbar spine fusion surgeries, post thoracotomy surgeries and hemorrhoidectomy surgeries. In paediatric patients it has shown effective pain control in hypospadias surgery, lower abdominal surgeries, hip surgeries and spine surgeries. It is considered a very safe block and very few adverse effects have been reported till date because the target area that is the vertebral transverse process is an avascular space and is away from all major vital structures and the neuraxis. The various approaches to the ESPB include thoracic, lumbar and sacral depending on the level of the target dermatomes. Sacral ESPB blocks lumbo-sacral dermatomes and is useful for lower abdominal and lower limb surgeries. On extensive literature review, we could not find any study directly comparing sacral ESPB and caudal epidural block in pediatric patients undergoing lower limb surgery. Therefore, this study to compare sacral ESPB with caudal epidural block has been planned.
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