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
|
|
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
|
|
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 cranialâ€toâ€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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