| 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
|
|
|
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
|
|
|
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. |