| CTRI Number |
CTRI/2023/08/056159 [Registered on: 04/08/2023] Trial Registered Prospectively |
| Last Modified On: |
02/08/2023 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A clinical trial to assess the effect of nerve block in children undergoing lower abdominal surgeries |
|
Scientific Title of Study
|
A comparison of analgesic efficacy of ultrasound guided External Oblique Intercostal Plane Block with IV opioids vs only IV opioids in pediatric patients undergoing upper abdominal surgeries: A Randomized Clinical Trial |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
DrChandni Sinha |
| Designation |
Additional Professor |
| Affiliation |
All India Institute of Medical Sciences,Patna |
| Address |
Dept of Anesthesia.
Room no. 2, B5A, New OT Complex, IPD building, AIIMS Patna,Phulwarisharif
Patna
BIHAR
801507
India |
| Phone |
7250333148 |
| Fax |
|
| Email |
chandni.doc@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DrChandni Sinha |
| Designation |
Additional Professor |
| Affiliation |
All India Institute of Medical Sciences,Patna |
| Address |
Dept of Anesthesia.
Room no. 2, B5A, New OT Complex, IPD building, AIIMS Patna,Phulwarisharif
BIHAR
801507
India |
| Phone |
7250333148 |
| Fax |
|
| Email |
chandni.doc@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DrChandni Sinha |
| Designation |
Additional Professor |
| Affiliation |
All India Institute of Medical Sciences,Patna |
| Address |
Dept of Anesthesia.
Room no. 2, B5A, New OT Complex, IPD building, AIIMS Patna,Phulwarisharif
BIHAR
801507
India |
| Phone |
7250333148 |
| Fax |
|
| Email |
chandni.doc@gmail.com |
|
|
Source of Monetary or Material Support
|
| All India Institute of Medical Sciences, Patna |
|
|
Primary Sponsor
|
| Name |
All India Institute of Medical Sciences, Patna |
| Address |
All India Institute of Medical Sciences, Patna Phulwarisharif patna-801507
Bihar |
| 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 Chandni Sinha |
All India Institute of Medical Sciences, Patna |
Dept of Anesthesia.
Room no. 2, B5A, New OT Complex, IPD building, AIIMS Patna,Phulwarisharif Patna-801507
Patna
BIHAR |
7250333148
chandni.doc@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee AIIMS Patna |
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 |
| Comparator Agent |
Only Intravenous fentanyl |
After induction of general anaesthesia patients in group II patients will recieve only intravenous fentanyl with increase in heart rate from 20% above baseline apart from the induction dose at a dose of 0.5mcg/kg |
| Intervention |
Ultrasound Guided External Oblique Intercostal Plane block with intravenous fentanyl |
After induction of general anaesthesia patients in group I will receive ultrasound guided External Oblique Intercostal Plane block. With patient in supine position high frequency linear transducer will be placed in the sagittal plane between midclavicular and anterior axillary line at the level of 6th rib. After optimization of image, needle will be inserted from superomedial to inferolateral direction through the external oblique muscle. 0.5ml/kg of 0.2% Ropivacaine will be deposited between the external oblique and intercostal muscle at the caudal end of the 6th rib.Any increase in heart rate from 20% above baseline would be treated with additional intravenous fentanly apart fromt the induction dose at the dose of 0.5mcg/kg
|
|
|
Inclusion Criteria
|
| Age From |
2.00 Month(s) |
| Age To |
7.00 Year(s) |
| Gender |
Both |
| Details |
ASA I and II patients scheduled for upper abdominal surgeries with unilateral incisions |
|
| ExclusionCriteria |
| Details |
Parent refusal to participate in the study
Patients hypersensitive to study medications
Patients with developmental or mental delay
Skin lesions or infection at the planned site of needle insertion
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant, Investigator and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Total Intraoperative fentanyl consumption
|
5, 30, 60, and 90 minutes after skin incision and at the end of surgery
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Postoperative pain score using FLACC score at 1, 4, 8, 16, 24 hours at rest.
To determine time to first rescue analgesic administration
To estimate total Tramadol consumption 24 hours postoperatively
Side effect likes nausea, vomiting and sedation and local anaesthetic toxicity
|
1,4,8,16,24 hours |
|
|
Target Sample Size
|
Total Sample Size="20"
Sample Size from India="20"
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)
|
14/08/2023 |
| 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="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
Nil |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - YES
- What data in particular will be shared?
Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).
- What additional supporting information will be shared?
Response - Study Protocol
Response - Statistical Analysis Plan
Response - Informed Consent Form
Response - Clinical Study Report
- Who will be able to view these files?
Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.
- For what types of analyses will this data be available?
Response - To achieve aims in the approved proposal.
- By what mechanism will data be made available?
Response (Others) -
- For how long will this data be available start date provided 01-12-2023 and end date provided 01-12-2033?
Response - Immediately following publication. No end date.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - nil
|
|
Brief Summary
|
This is a randomized clinical trial to study the analgesic efficacy of ultrasound guided External Oblique Intercostal Plane Block in pediatric patients undergoing upper abdominal surgeries.Ultrasound guided external oblique intercostal plane block will be given in supine position to all the patients belonging to group I alongwith intravenous opioids and group II will recieve only intravenous opioids. Intraoperative any increase in HR/MAP more than 20% intraoperatively will be treated with additional fentanyl doses of 1 mcg/kg and total intraoperative fentanyl consumption will be noted and compared in the two groups. Both groups will be compared with respect to Postoperative pain score using FLACC score at 1, 4, 8, 16, 24 hours at rest, time to first rescue analgesic administration , total Tramadol consumption 24 hours postoperatively, side effect likes nausea, vomiting and sedation and local anaesthetic toxicity |