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CTRI Number  CTRI/2023/07/054892 [Registered on: 06/07/2023] Trial Registered Prospectively
Last Modified On: 01/01/2024
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   A clinical trial to compare the efficacy of two plane blocks,ultrasound-guided erector spinae plane block and ultrasound-guided transversus abdominis plane block for post-operative analgesia in children undergoing lower abdominal surgery under general anaesthesia. 
Scientific Title of Study   Comparison of ultrasound-guided erector spinae plane block and ultrasound-guided transversus abdominis plane block for post-operative analgesia in children undergoing lower abdominal surgery under general anaesthesia. 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  S Vignesh  
Designation  Postgraduate  
Affiliation  ABVIMS and Dr.RML HOSPITAL  
Address  Department of Anaesthesia, ABVIMS and Dr.RML hospital, Baba Kharak Singh Road, Connaught Place, New Delhi

New Delhi
DELHI
110001
India 
Phone  9543414570  
Fax    
Email  vickyshanmugavel@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Akhilesh Gupta 
Designation  Professor  
Affiliation  ABVIMS and Dr.RML HOSPITAL 
Address  Department of Anaesthesia, 3rd floor,PGI Building, ABVIMS and Dr.RML hospital, Baba Kharak Singh Road, Connaught Place, New Delhi

New Delhi
DELHI
110001
India 
Phone  9810685426  
Fax    
Email  drakhileshgupta@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Akhilesh Gupta 
Designation  Professor  
Affiliation  ABVIMS and Dr.RML HOSPITAL 
Address  Department of Anaesthesia, 3rd floor,PGI Building, ABVIMS and Dr.RML hospital, Baba Kharak Singh Road, Connaught Place, New Delhi

New Delhi
DELHI
110001
India 
Phone  9810685426  
Fax    
Email  drakhileshgupta@gmail.com  
 
Source of Monetary or Material Support  
Department of Anaesthesia, ABVIMS and Dr.RML HOSPITAL, Baba Kharak Singh Road, Connaught Place, New Delhi Delhi - 110001  
 
Primary Sponsor  
Name  Department of Anaesthesia  
Address  ABVIMS and Dr.RML Hospital, Baba Kharak Singh Road, Connaught Place, New Delhi Delhi -110001 
Type of Sponsor  Government medical college 
 
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 S Vignesh  ABVIMS and Dr.RML Hospital  Department of Anaesthesia, PGI Building, 3rd floor, ABVIMS and Dr.RML Hospital, Baba Kharak Singh Road, Connaught Place, New Delhi
New Delhi
DELHI 
9543414570

vickyshanmugavel@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee,ABVIMS and Dr.RML hospital,New Delhi  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: G891||Acute pain, not elsewhere classified,  
 
Intervention / Comparator Agent
Modification(s)  
Type  Name  Details 
Intervention  Ultrasound guided Erector Spinae Plane Block   Ultrasound guided Erector Spinae Plane Block for post operative analgesia in children undergoing lower abdominal surgery under general anaesthesia  
Comparator Agent  Ultrasound guided Transversus Abdominis Plane block  Ultrasound guided Tranversus Abdominis Plane Block for post operative analgesia in children undergoing lower abdominal surgery under general anaesthesia 
 
Inclusion Criteria  
Age From  6.00 Month(s)
Age To  7.00 Year(s)
Gender  Both 
Details  1. Age 6 months to 7 years.
2. ASA grade I
3. Patients undergoing lower abdominal surgery. 
 
ExclusionCriteria 
Details  1.Refusal of Consent from parents.
2. Allergy to local anaesthesia
3.Infection at injection site 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Average CHEOPS score till first rescue analgesia.  After the arrival of the patient in the recovery room at 15 minutes, 30 minutes, 1, 2, 4, 6, 9 & 12 hours. 
 
Secondary Outcome  
Outcome  TimePoints 
1. Total rescue analgesia given in 12 hours.
2. Time taken for the first rescue analgesia. 
1. First 12 hours of postoperative period
2.No specific time points.  
 
Target Sample Size   Total Sample Size="70"
Sample Size from India="70" 
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   N/A 
Date of First Enrollment (India)   16/07/2023 
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="5"
Days="0" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   None yet 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary
Modification(s)  
AIM
To compare ultrasound-guided erector spinae plane block and ultrasound-guided transversus abdominis plane block for post-operative analgesia in children undergoing lower abdominal surgery under general anaesthesia.

OBJECTIVES
 Primary Objective
To compare ultrasound-guided erector spinae plane block and ultrasound-guided transversus abdominis plane block for post-operative analgesia in children undergoing lower abdominal surgery under general anaesthesia.
Secondary Objectives
1. Time taken for the first rescue analgesia.
2. To find out total rescue analgesia requirement in 12 hours in each group.

METHODOLOGY
Pre anaesthetic evaluation will be done for all the patients one day before the day of surgery. They will be instructed to be nil per oral (NPO) at least 8 hours for solids, 6 hours for formula/non-human milk, 4 hours for breast milk and 2 hours for clear fluids. Written informed consent for study procedures will be obtained from the parents of the patients. On the day of surgery all patients will be re-assessed in the preoperative area. ASA standard monitors will be attached which includes Non-invasive blood pressure (NIBP), three lead electrocardiography (ECG) and Masimo Pulse oximetry (SpO2) will be placed on the index finger of the upper extremity. Baseline parameters will be noted. General anesthesia will be induced with incremental sevoflurane in 100% oxygen which will be followed by placement of intravenous cannula. After securing IV cannula, injection fentanyl 2μg/kg intravenously and injection vecuronium 0.1mg/kg intravenously will be given. Patients will be mask ventilated for 3 minutes using oxygen and inhalational sevoflurane to achieve MAC of 1 ± 0.2. Airway will be secured with appropriate size laryngeal mask airway.
Before proceeding to the surgery, under all aseptic precautions, ultrasound-guided transversus abdominis plane block will be performed in one group and ultrasound-guided erector spinae plane block will be done in the other group.

Ultrasound guided erector spinae plane block technique –
After all aseptic preparation, under ultrasound guidance erector spinae plane block will be performed. The linear transducer of 10-14 MHz will be used after sterile gel and sterile plastic cover application. The probe will be placed into a longitudinal, parasagittal orientation over the tip of the transverse processes of L2. A needle will be inserted in-plane, in a cranial‐to‐caudal direction until contacting the tip of the transverse process (L2) underneath the fascia of the erector spinae muscle. Local anaesthetic drug 0.25% bupivacaine will be injected at 0.5ml/kg, after careful aspiration. The spread of local anaesthetic will be observed using the ultrasound.
Ultrasound guided transversus abdominis plane (TAP) block
Ultrasound guided transversus abdominis will block will be performed under strict aseptic precautions using a linear transducer of 10-14 MHz after sterile gel and sterile plastic cover application ultrasound probe will be placed on the lateral abdominal wall cephalad to the iliac crest and caudal to the costal margin. The probe will be adjusted as necessary in cephalad or caudal direction until a clear optimized image of the three lateral abdominal muscles and TAP is obtained. The needle tip will be introduced into the TAP plane between internal oblique and transversus abdominis muscles using in plane technique and the drug 0.25% bupivacaine at 0.5ml/kg will be administered into the plane. The spread of local anaesthetic within the plane will be observed.

POST- OPERATIVE PAIN MANAGEMENT:
The following parameters will be assessed in the recovery room –
1. The duration of analgesia will be assessed by the time period between the administration of the block and the time of the first rescue analgesia.
2. The quality of the pain will be assessed by the CHEOPS score after the arrival of the patient in the recovery room at 15 minutes, 30 minutes, 1, 2, 4, 6, 9 and 12 hours.

Patients with CHEOPS score equal to or more than 6 will be given injection paracetamol 10 mg/kg intravenously as rescue analgesia for post-operative pain.

 
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