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CTRI Number  CTRI/2024/07/070499 [Registered on: 11/07/2024] Trial Registered Prospectively
Last Modified On: 08/07/2024
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   Is external oblique intercostal is better than subcostal Transabdominal plane block for abdominal surgeries in children? 
Scientific Title of Study   Comparison of External oblique intercostal plane block and Subcostal Transverse Abdominal plane block on intraoperative and postoperative analgesic effect in paediatric patients undergoing upper abdominal surgeries. 
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 Gautham R 
Designation  Junior Resident 
Affiliation  Institute of medical sciences, Banaras Hindu university  
Address  Department of Anaesthesiology office, 1st floor, Sir Sunderlal hospital, Banaras Hindu University, Pandit Madan Mohan Malaviya Road, Kabir colony, Varanasi. Uttar Pradesh

Varanasi
UTTAR PRADESH
221005
India 
Phone  9344220878  
Fax    
Email  gautham977@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Amrita Rath  
Designation  Assistant Professor  
Affiliation  Institute of medical sciences, Banaras Hindu university  
Address  Department of Anaesthesiology office, 1st floor, Sir Sunderlal hospital, Banaras Hindu university , Pandit Madan Mohan Malaviya road, Kabir colony, Varanasi. Uttar Pradesh

Varanasi
UTTAR PRADESH
221005
India 
Phone  7379140545  
Fax    
Email  amritar@bhu.ac.in  
 
Details of Contact Person
Public Query
 
Name  Dr Amrita Rath  
Designation  Assistant Professor  
Affiliation  Institute of medical sciences, Banaras Hindu university  
Address  Department of Anaesthesiology office, 1st floor, Sir Sunderlal hospital, Banaras Hindu university , Pandit Madan Mohan Malaviya road, Kabir colony, Varanasi. Uttar Pradesh

Varanasi
UTTAR PRADESH
221005
India 
Phone  7379140545  
Fax    
Email  amritar@bhu.ac.in  
 
Source of Monetary or Material Support  
material support only by IMS, BHU, Varanasi 
 
Primary Sponsor  
Name  Institute of medical sciences 
Address  Institute of medical sciences, Banaras Hindu university. Varanasi 221005 
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 Gautham R  Institute of medical sciences, Banaras Hindu university  Department of Anaesthesiology office, 1st floor, Sir Sunderlal hospital, Banaras Hindu University, Pandit Madan Mohan Malaviya Road, Kabir colony, Varanasi. Uttar Pradesh
Varanasi
UTTAR PRADESH 
9344220878

gautham977@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institute of medical sciences_ethics_committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: O||Medical and Surgical,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  external oblique intercostal plane block   After induction of general anesthesia patients are positioned in the supine position with their ipsilateral arm abducted. A 12-15 MHz linear transducer was used for ultrasonography. With the doctor at the patient ipsilateral shoulder, the chest wall is symmetrically scanned. The transducer is placed in the Sagittal plane between the mid clavicular and anterior axillary line at the level of the 6th rib with the orientation marker directed cranially. Rib 6 can be identified either by placing the ultrasound transducer at the lower costal margin where the 10th rib is identified and by counting up or by identifying the 7th rib at the level of diploid process and then moving the transducer one rib up. Rotating the transducer so that cranial end is directed medially and caudal end laterally to produce a para median Sagittarius oblique view with the short axis view of the ribs approximately 1 to 2 cm lateral to the mid clavicular line. Advancing the needle in plane from superb medial to inferior lateral direction through the external oblique muscle, the local anaesthetic 0.5ml/kg of 0.25% levobupivacaine is placed between external oblique muscle and intercostal muscle at the caudal end of the 6th rib and between 6th and 7th rib. Hydro dissection of the two muscles between 6th and 7th ribs noted and the needle is directed caudally toward the 8th rib chasing the local anaesthetics. 
Comparator Agent  subcostal transverse abdominal plane block  The probe is placed initially below the xiphoid process to view the linea alba and directed obliquely down the costal margin keeping the rectus abdominals muscle in view. The rectus abdominus and the underlying transverse abdominus are identified. Needle is inserted in plane from medial to lateral and the tip is placed in the fascia plane between the rectus abdominals and transverse abdominus . 0.5ml/kg of 0.25% levobupivacaine local anaesthetic is injected into the plane and hydro dissection of the two muscles is observed. 
 
Inclusion Criteria  
Age From  7.00 Year(s)
Age To  14.00 Year(s)
Gender  Both 
Details  Paediatric patients undergoing upper abdominal surgeries under general Anesthesia.  
 
ExclusionCriteria 
Details  1. Allergy to local anaesthetic
2. Bleeding disorders
3. Localised infections
4. Neurological disorders
5. Respiratory / cardiac disease
6. Patients not giving consent
7. Patients with poly trauma (cardio thoracic/ CNS)
 
 
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 
1.To compare the postoperative NRS between the external oblique intercostal plane block and subcostal transverse abdominal plane block  0 min,15 min, 30 mins, 60 mins, 2 hrs,6hrs,12 hrs and 24 hrs postoperatively 
 
Secondary Outcome  
Outcome  TimePoints 
1.To compare the hemodynamic stability intra operatively between external oblique intercostal plane and subcostal transverse abdominal plane block   Systolic blood pressure, diastolic blood pressure, mean arterial pressure, heart rate at baseline, 15 minutes, 30 minutes, 45 minutes , 60 minutes , 75 minutes , 90 minutes, 105 minutes, 120 minutes and fentanyl consumption intraoperatively. 

2. the total dose of rescue analgesia injection required to achieve adequate analgesia in the first 24 hours post-surgery between two groups.

 
rescue analgesia - tramadol 1mg/kg; maximum dose 3mg/kg over 24 hours.
adequate analgesia - NRS less than 4 

•To compare the parents satisfaction using five-point Likert scale in both the groups
 
Likert scale checked 24 hours after surgery  
4. Time needed to perform technique (in minutes)  . It is defined as the time needed for adequate ultrasound visualization, needle introduction and drug injection (time from placement of ultrasound probe on the patient’s skin to the end of local anesthetic injection
 
 
Target Sample Size   Total Sample Size="55"
Sample Size from India="55" 
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)   01/08/2024 
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="1"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
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  

This study will be conducted in Department of anesthesiology, Institute of Medical Sciences, Banaras Hindu University, Varanasi. After approval from hospital research and ethical committee, a Prospective Randomized study will be conducted on patients coming to Institute of Medical Sciences, BHU, Varanasi.

Once the patients are enrolled, they will be next seen on the day of surgery in the operation theatre. Before taking them into the theatre, the Sono anatomy of the patient’s TAP block area and EOA block area will be checked using a ultrasound machine. The patients will be randomized into either Group E or Group T. Randomization will be done using computer generated random number sequence. Allocation concealment will be done using serially numbered opaque sealed envelopes. The process of allocation will be done by a staff member who is not a part of the study group. There will be (66) such sealed opaque envelopes pre-designed with equal numbers of EOA block and TAP Block treatments.

One day prior to the scheduled surgery, all the patients will be instructed on how to evaluate their own pain by using a 10cm Numeric rating pain scale (0-no pain; 10- maximum pain). In the operating room, after attaching the standard ASA monitors and IV lines, the patient will be induced using standardized general anesthesia protocol as routinely followed in our department. IV induction along with muscle relaxation followed by endotracheal intubation will be done. Ventilation will be titrated to ETCO2 between 35-45 mm Hg. Analgesia maintained with Inj. Fentanyl 2mcg/ kg at induction. If one or both of the Heart rate and blood pressure goes more than 20% of the baseline, Injection fentanyl (0.5 mics/Kg) will be given intra-operatively.  Inj. PCM 15 mg/kg IV will be given to all the patients prior to skin incisions and no other painkillers will be administered. No local suture incision and line/ port site infiltration will be allowed. The Blocks will be given after induction.

 

Group T:  The probe is placed initially below the xiphoid process to view the Linea alba and directed obliquely down the costal margin keeping the rectus abdominus muscle in view. The rectus abdominus and the underlying transverse abdominus muscles are identified. Needle is inserted in plane from medial to lateral and the tip is placed in the fascial plane between the rectus abdominus and transverse abdominus. 0.5 ml/Kg of 0.25% Levobupivacaine local anesthetic is injected into the plane and hydro dissection of the two muscles is observed.

Group E:

Patients positioned in the supine position with their ipsilateral arm abducted. A 12-15 MHz linear transducer was used for ultrasonography. With the proceduralist at the patient’s ipsilateral shoulder, the chest wall is systematically scanned. The transducer is placed in the sagittal plane between midclavicular and anterior axillary line at the level of 6th rib with the orientation marker directed cranially. Rib 6 can be identified either by placing the ultrasound transducer at the lower costal margin where the 10th rib is identified and by counting up or by identifying the 7th rib at the level of xiphoid process and then moving the transducer one rib up. Rotating the transducer so that the cranial end is directed slightly medially and caudal end laterally to produce a paramedian sagittal oblique view with the short axis view of the ribs approx. 1 to 2 cm lateral to the mid clavicular line. Advancing the needle in plane from superomedial to inferolateral direction through the EOM, the LA is placed between EOM and ICM at the caudal end of the 6th rib and between 6th and 7th rib. Hydro dissection of the two muscles between 6th and 7th ribs noted and needle is directed caudally toward the 8th rib chasing the LA.

The obtained data will be recorded and the results will be statistically analysed by appropriate statistical method. A p value of 0.05 will be considered as significant.

 
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