| CTRI Number |
CTRI/2023/04/051388 [Registered on: 06/04/2023] Trial Registered Prospectively |
| Last Modified On: |
24/07/2024 |
| 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
|
Ultrasound guided Errector spinae plane block vs caudal epidural block for postoperative pain relief in children |
|
Scientific Title of Study
|
Ultrasound-Guided sacral erector spinae plane block versus caudal epidural block for postoperative analgesia in children undergoing
hypospadias surgery: Randomized controlled study |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Harishchandra Gupta |
| Designation |
Junior resident (PG-JR) |
| Affiliation |
Junior resident (PG-JR),AIIMS raipur |
| Address |
B block or complex 4th floor, B block AIIMS Raipur, Tatibandh, Raipur, Chhattisgarh 492099
Raipur CHHATTISGARH 492009 India |
| Phone |
|
| Fax |
|
| Email |
harishgp2011@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Mayank Kumar |
| Designation |
Associate Professor |
| Affiliation |
Associate Professor, Department of Anaesthesiology, AIIMS raipur |
| Address |
Department of Anaesthesiology
AIIMS Raipur, Tatibandh, Raipur, Chhattisgarh 492099
Raipur CHHATTISGARH 492099 India |
| Phone |
|
| Fax |
|
| Email |
mayanksonupmch@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Dr Mayank Kumar |
| Designation |
Associate Professor |
| Affiliation |
Associate Professor, Department of Anaesthesiology, AIIMS raipur |
| Address |
Department of Anaesthesiology
AIIMS Raipur, Tatibandh, Raipur, Chhattisgarh 492099
Raipur CHHATTISGARH 492099 India |
| Phone |
|
| Fax |
|
| Email |
mayanksonupmch@gmail.com |
|
|
Source of Monetary or Material Support
|
| AIIMS Raipur medical college |
|
|
Primary Sponsor
|
| Name |
AIIMS Raipur |
| Address |
Gate No, 1, Great Eastern Rd, opposite Gurudwara, AIIMS Campus, Tatibandh, Raipur, Chhattisgarh 492099 |
| Type of Sponsor |
Research institution and hospital |
|
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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 Harishchandra Gupta |
AIIMS Raipur |
AIIMS Raipur, GE road B block OT complex, 4th floor, AIIMS Raipur, Tatibandh, Raipur
Chhattisgarh - 492099 Raipur CHHATTISGARH |
9664566706
harishgp2011@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| The Institute Ethics Committee, AIIMS Raipur |
Approved |
|
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Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: Q549||Hypospadias, unspecified, (2) ICD-10 Condition: Q549||Hypospadias, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Caudal epidural block |
1 ml/kg of 0.25% Bupivacaine And observed for 24 hr |
| Intervention |
Ultrasound-Guided sacral erector spinae plane block |
1 ml/kg of 0.25% Bupivacaine under USG guided ESP observed for 24 hours |
|
|
Inclusion Criteria
|
| Age From |
1.00 Year(s) |
| Age To |
6.00 Year(s) |
| Gender |
Male |
| Details |
from 1 yr of age to 6 yr of age |
|
| ExclusionCriteria |
| Details |
Patients parents refusal
Patients with any contraindications to regional anaesthesia
History of development delay or mental retardation, which will make observational pain intensity assessment difficult
History of allergic reaction to local anaesthetic
Rash or skin infection at the site of injection
Anatomical abnormalities
Bleeding diathesis
Coagulation disorder
History of renal, hepatic, cardiac disorder, upper or lower infection or any neurological abnormalities |
|
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Method of Generating Random Sequence
|
Computer generated randomization |
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Method of Concealment
|
Other |
|
Blinding/Masking
|
Investigator Blinded |
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Primary Outcome
|
| Outcome |
TimePoints |
| Postoperative pain intensity by FLACC scale |
Postoperative pain intensity by FLACC scale |
|
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Secondary Outcome
|
| Outcome |
TimePoints |
Total analgesic requirement
It is the duration required for 1st rescue postoperative analgesia
Hemodynamic- Heart rate, Systolic and Diastolic blood pressure and Oxygen saturation recorder before the block, every 10 minutes after caudal block and 15 minutes after recovery
Parents satisfaction on postoperative day 1[0- No satisfaction,10- Total satisfaction] |
Rescue analgesics and parents satisfaction |
|
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Target Sample Size
|
Total Sample Size="62" Sample Size from India="62"
Final Enrollment numbers achieved (Total)= "62"
Final Enrollment numbers achieved (India)="62" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
11/04/2023 |
| Date of Study Completion (India) |
10/06/2024 |
| 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
|
|
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Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
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Brief Summary
|
Hypospadias occurs in 1 in 200 new born males and its correction is one of the most common Urological surgeries performed in children [1]. Various methods and medications that have Been tried to provide postoperative pain relief in the paediatric population can be associated Side effects. Use of opioid in paediatrics shows somnolence, vomiting and also respiratory Depression as an alarming side effect [2].Regional analgesia utilized for this penile reconstructive surgery is typically either a caudal Or dorsal penile nerve block. Caudal blocks are the most commonly performed blocks in Children undergoing pelvic genitourinary surgery and are frequently performed for Hypospadias surgery [3].Caudal injection through the sacral hiatus is easy to perform. For most of the year’s caudal Block is considered to be effective in further prolonging postoperative analgesia. However,Variations in sacral anatomy, the potential for coagulopathy and the possible infection risks Contribute to the complexity of application and success of the block. Caudal block may also Lead to some complications like motor block, urinary retention, block failure, blood Aspiration, and intra- vascular injection. [2]Nowadays, the use of ultrasound (US)-guided nerve block resulted in the revolutionary Change in the field of regional anaesthesia in paediatrics. Many truncal blocks are used for Both upper and lower abdominal surgeries with a high success rate [4]. Nerve blockade has Been shown to be as effective as caudal block for infra umbilical surgeries. Recent literature Suggests that, as an alternative method, peripheral nerve blocks have longer analgesia Duration and fewer adverse effects than neuraxial blocks [5,6]Erector spinae plane block (ESPB) was first described by Foreroin 2016 as an interfascial plane block which was 1st performed at the upper thoracic levels for the treatment of thoracic neuropathic pain; eventually it was used in lower thoracic and lumbar levels.ESP block carries promise as a simpler and safer alternative to caudal block. The efficacy of this technique for the management of acute and chronic pain in the thoracic region is reported to be effective [7,8]. Case reports on sacral ESP block states that sacral erector spinae plane block provides surgical anaesthesia in ambulatory anorectal surgery [18].ESP block when used in paediatric patients presenting for hip surgery improved the postoperative analgesia. Therefore, we consider that in sacral region, it may have the same anatomical considerations to get good result.
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