| CTRI Number |
CTRI/2024/10/075676 [Registered on: 23/10/2024] Trial Registered Prospectively |
| Last Modified On: |
23/10/2024 |
| 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
|
Pain relief in children undergoing lower abdominal surgery by ultrasound guided caudal block vs post quadratus lumborum block. |
|
Scientific Title of Study
|
Comparison Of Analgesic Efficacy Of Ultrasound guided Caudal Block Versus Posterior Quadratus Lumborum Block In Paediatric Abdominal Surgeries: A Single Centered Randomized Controlled Trial. |
| Trial Acronym |
NILL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr. Nidhi Singh |
| Designation |
Fellow In Pediatric Anesthesia |
| Affiliation |
Post Graduate Institute Of Child Health,Noida. |
| Address |
Department Of Pediatric Anesthesia, Post Graduate Institute of Child Health, Sector 30, Noida, Uttar Pradesh.
Gautam Buddha Nagar
UTTAR PRADESH
201303
India |
| Phone |
8861514064 |
| Fax |
|
| Email |
singhnidhisakarwar@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr.Poonam Motiani |
| Designation |
Professor,Post Graduate Institute Of Child Health,Noida. |
| Affiliation |
Post Graduate Institute of child and health,Noida |
| Address |
Department Of Pediatric Anesthesia, Post Graduate Institute of Child Health, Sector 30, Noida, Uttar Pradesh
Gautam Buddha Nagar
UTTAR PRADESH
201303
India |
| Phone |
9810952715 |
| Fax |
|
| Email |
poonammotiani@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr. Nidhi Singh |
| Designation |
Fellow In Pediatric Anesthesia, Post Graduate Institute Of Child Health,Noida. |
| Affiliation |
Post Graduate Institute of child and health,Noida |
| Address |
Department Of Pediatric Anesthesia, Post Graduate Institute of Child Health, Sector 30, Noida, Uttar Pradesh.
Gautam Buddha Nagar
UTTAR PRADESH
201303
India |
| Phone |
01202455552 |
| Fax |
|
| Email |
singhnidhisakarwar@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department Of Pediatric Anesthesia, Post Graduate Institute of Child Health, Sector 30, Noida, Uttar Pradesh.
|
|
|
Primary Sponsor
|
| Name |
Department Of Pediatric Anesthesia Post Graduate Institute Of Child Health |
| Address |
Department Of Pediatric Anesthesia, Post Graduate Institute of Child Health, Sector 30, Noida, Uttar Pradesh. |
| 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 |
| DrNidhi Singh |
Post Graduate Institute of child health. |
Department Of Pediatric Anesthesia, Post Graduate Institute of Child Health, Sector 30, Noida, Uttar Pradesh
Gautam Buddha Nagar
UTTAR PRADESH |
8861514064
singhnidhisakarwar@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Superspeciality Pediatric Hospital & Postgraduate Teaching Institute |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
, (1) ICD-10 Condition: K409||Unilateral inguinal hernia, without obstruction or gangrene, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Posterior quadratus lumborum block (Group B) |
Drug-Bupivacaine
Conc-0.125%
vol-0.5ml/kg
Dexmedetomidine(adjuvant)-1mcg/kg. DURATION OF STUDY -6 MONTHS. |
| Comparator Agent |
USG guided caudal block(Group A) |
Drug: Bupivacaine.
conc:0.125%
vol:1.25ml/kg.
Dexmedetomidine(adjuvant)-1mcg/kg. DURATION OF STUDY- 6 MONTHS.
|
|
|
Inclusion Criteria
|
| Age From |
6.00 Month(s) |
| Age To |
8.00 Year(s) |
| Gender |
Both |
| Details |
PATIENTS UNDERGOING LOWER ABDOMINAL SURGERY OF AGE GROUP BETWEEN 6 MONTHS TO 8 YEARS OF AGE OF EITHER SEX OF ASA CLASS 1 AND 2 ARE INCLUDED FOR THE STUDY. |
|
| ExclusionCriteria |
| Details |
bleeding disorder.
caudal space deformities.
parents refusal for regional anaesthesia.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Comparision of USG guided caudal block with posterior quadratus lumborum block in pediatric patients undergoing lower abdominal surgeries by assessing time to first rescue analgesic in first 24 hour postoperatively. |
Intra operatively HR,NIBP,MAP,SPO2 at baseline,incision,15 mins,30 mins,45 min after incision.
Post operatively FLACC score at 15 min,30min,1hr,6hr,12hr,18hr,24hr. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| FLACC score postoperatively at fixed time interval. Total paracetamol consumption, fentanyl consumption in first 24 hour & incidence of failed block. |
FLACC@15MIN,30,1HR,6HR,12HR, 18HR,24HR. |
|
|
Target Sample Size
|
Total Sample Size="24"
Sample Size from India="24"
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 3 |
|
Date of First Enrollment (India)
|
06/11/2024 |
| 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="0"
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
|
The major responsibility of the anesthesiologist is to provide adequate surgical anesthesia and postoperative analgesia for patients with minimum complications .Caudal epidural block is the most commonly performed method of regional anesthesia technique in pediatric group ,owing to its ease of performance ,short learning curve and safety .the most encountered complications are block failure , blood aspiration and intravascular injections. Quadratus lumborum block entails deposition of the local anesthetic around the fascial planes of the quadratus muscle to block the somatic thoracolumbur nerves and the sympathetic trunk through the paravertebral route, providing extensive spread. Hence we aim to investigate the analgesic effect of posterior quadratus lumborum block with caudal block in children undergoing lower abdominal surgeries.
|