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CTRI Number  CTRI/2024/03/063604 [Registered on: 05/03/2024] Trial Registered Prospectively
Last Modified On: 25/05/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Surgical/Anesthesia
Preventive 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   A study to compare the pain relief by two modalities caudal epidural block and quadratus lumborum block in pediatric lower abdominal surgeries 
Scientific Title of Study   Ultrasound-guided quadratus lumborum block versus ultrasound-guided caudal epidural block for post-operative analgesia in children undergoing lower abdominal surgeries: A prospective randomized 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 Keerthi 
Designation  Post graduation junior resident  
Affiliation  AIIMS Raipur  
Address  Seminar room, OT complex, B block, 4th floor, department of anaesthesiology, All india institute of medical sciences, G.E. Road, Tatibandh, Raipur, Chhattisgarh 492099

Raipur
CHHATTISGARH
492099
India 
Phone  9566064825  
Fax    
Email  keerthigmc@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Mayank Kumar 
Designation  Associate professor  
Affiliation  AIIMS Raipur  
Address  Faculty room no. 3, A block, department of anaesthesiology, All india institute of medical sciences, Great eastern road, Tatibandh, Raipur, Chhattisgarh 492099

Raipur
CHHATTISGARH
492099
India 
Phone  9971760416  
Fax    
Email  mayanksonupmch@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Mayank Kumar 
Designation  Associate professor  
Affiliation  AIIMS Raipur  
Address  Faculty room no.3, A block, department of anaesthesiology, All india institute of medical sciences, Great eastern road, Tatibandh, Raipur, Chhattisgarh 492099

Raipur
CHHATTISGARH
492099
India 
Phone  9971760416  
Fax    
Email  mayanksonupmch@gmail.com  
 
Source of Monetary or Material Support  
All india institute of medical sciences, Raipur. 
 
Primary Sponsor  
Name  All india institute of medical sciences Raipur 
Address  All india institute of medical sciences, Great eastern road, Tatibandh, Raipur, Chhattisgarh 492099 
Type of Sponsor  Research institution and hospital 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Keerthi  All India Institute of Medical Sciences, Raipur.  Office Room Anaesthesia, B block OT complex,4th floor, AIIMS Raipur, Tatibandh, Chhattisgarh 492099
Raipur
CHHATTISGARH 
9566064825

keerthigmc@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institute Ethics Committee, AIIMS Raipur   Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: PCS||, (2) ICD-10 Condition: K929||Disease of digestive system, unspecified, (3) ICD-10 Condition: K409||Unilateral inguinal hernia, without obstruction or gangrene, (4) ICD-10 Condition: K402||Bilateral inguinal hernia, withoutobstruction or gangrene, (5) ICD-10 Condition: K639||Disease of intestine, unspecified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Ultrasound-guided caudal epidural block   Route of administration: epidural injection. Drug: 0.25% bupivacaine. Dose: 1ml/kg Time: 15 mins before the start of surgery 
Intervention  Ultrasound-guided quadratus lumborum block  Route of administration: fascial plane between the quadratus lumborum muscle and psoas major muscle. Drug: 0.25% bupivacaine. Dose: 0.5ml/kg. Time: 15 mins before the start of surgery. 
 
Inclusion Criteria  
Age From  1.00 Year(s)
Age To  7.00 Year(s)
Gender  Both 
Details  Children of ASA 1 and 2 undergoing lower abdominal surgery 
 
ExclusionCriteria 
Details  Patients parents refusal
Patients with any contraindications to regional anesthesia
History of developmental delay or mental retardation, which will make observational pain intensity assessment difficult
History of allergic reaction to local anesthetic
Rash or skin infection at the site of injection
Anatomical abnormalities
Bleeding diathesis
Coagulation disorder
History of renal, hepatic, cardiac disorder, upper or lower airway infection or any neurological abnormalities.

 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
To assess the postoperative pain intensity by FLACC scale   At baseline, 1 hr, 2 hrs, 4 hrs, 6 hrs, 8 hrs, 12 hrs and 24 hrs post-operatively 
 
Secondary Outcome  
Outcome  TimePoints 
1.Time to first post-operative rescue analgesic requirement
2.Total dose of paracetamol requirement post-operatively
3.Any adverse effects like hypotension, bradycardia, respiratory depression
 
At baseline, 1 hr, 2 hrs, 4 hrs, 6 hrs, 8 hrs, 12 hrs & 24 hrs post-operatively 
 
Target Sample Size   Total Sample Size="50"
Sample Size from India="50" 
Final Enrollment numbers achieved (Total)= "50"
Final Enrollment numbers achieved (India)="50" 
Phase of Trial   Phase 3 
Date of First Enrollment (India)   11/03/2024 
Date of Study Completion (India) 04/03/2025 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) 04/03/2025 
Estimated Duration of Trial   Years="1"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  
Completed 
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 - NO
Brief Summary  
Lower abdominal surgeries are commonly done in pediatric group of patients and are associated with severe postoperative pain. Adequate analgesia during the perioperative period is vital to reduce the stress response to surgery and perioperative morbidity and to hasten the recovery.

For effective perioperative analgesia, regional anesthetic methods can be used along with other analgesics. One of the most often used methods of regional anesthesia in children is caudal epidural block, which provides efficient postoperative analgesia for sub-umbilical interventions. 

Regional anesthesia in pediatrics has undergone a radical change as a result of the use of ultrasonography (US)-guided nerve blocks. Both upper and lower abdominal procedures using many truncal blocks have a good success rate. For infra-umbilical procedures, nerve blockade has been demonstrated to be just as successful as caudal block.

A recently discovered block called the quadratus lumborum block (QLB) uses ultrasound to successfully deliver secure and long-lasting analgesia. It is a fascial plane block that is becoming more and more common for pain control after lower abdominal surgeries. By using ultrasonography (US) to image the abdominal muscles as a guide, it is carried out with a local anesthetic injection between the Quadratus lumborum muscle and Psoas major muscle, and it is anticipated that analgesia will be provided from the level of the T7-L1 dermatome segment.

Justification: 

Caudal block provides adequate analgesia during the intraoperative and early post-operative stages with more effective and consistent results. However it is associated with adverse effects and complications.

For somatic analgesia of both the upper and lower abdomen, the QL block is a novel abdominal truncal block. The QL block provides an excellent analgesic effect, with patients reporting a reduction in pain of 1-2/10 on the pain scale.
According to observations, QL block led to shorter hospital stays and lower postoperative pain scores.

Very few studies have been done comparing Quadratus lumborum block and caudal block for lower abdominal surgeries in pediatric patients, hence we propose to carry out a Prospective Randomised Controlled Trial to compare the effectiveness of caudal epidural block against ultrasound-guided quadratus lumborum block as a postoperative analgesic in pediatric lower abdominal procedures.
 
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