| CTRI Number |
CTRI/2024/12/077852 [Registered on: 09/12/2024] Trial Registered Prospectively |
| Last Modified On: |
07/12/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
adding dexamethasone to bupivacaine as an adjuvant on Ultrasound-guided Transverse Abdominis Plane block in children undergoing appendicectomy:A prospective study |
|
Scientific Title of Study
|
Efficacy of adding dexamethasone to bupivacaine on the quality of Ultrasound-guided Transverse Abdominis Plane block in children undergoing appendicectomy: A prospective study |
| 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 Anushka sharma |
| Designation |
Junior resident, Department of Anesthesiology |
| Affiliation |
DR.DY.PATIL MEDICAL COLLEGE AND RESEARCH CENTRE |
| Address |
DR.DY.PATIL MEDICAL COLLEGE,HOSPITAL AND RESEARCH CENTRE,PIMPRI, PUNE
Pune
MAHARASHTRA
411018
India |
| Phone |
7772979608 |
| Fax |
|
| Email |
anushka.as.sharma.2898@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sonal Khatavkar |
| Designation |
Professor, Department of Anesthesiology |
| Affiliation |
DR.DY.PATIL MEDICAL COLLEGE AND RESEARCH CENTRE |
| Address |
DR.DY.PATIL MEDICAL COLLEGE,HOSPITAL AND RESEARCH CENTRE,PIMPRI, PUNE
Department of Anesthesia
Pune
MAHARASHTRA
411018
India |
| Phone |
9820434472 |
| Fax |
|
| Email |
ksonal0711@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sonal Khatavkar |
| Designation |
Professor, department of Anesthesiology |
| Affiliation |
DR.DY.PATIL MEDICAL COLLEGE AND RESEARCH CENTRE |
| Address |
DR.DY.PATIL MEDICAL COLLEGE,HOSPITAL AND RESEARCH CENTRE,PIMPRI, PUNE
Pune
MAHARASHTRA
411018
India |
| Phone |
9820434472 |
| Fax |
|
| Email |
ksonal0711@gmail.com |
|
|
Source of Monetary or Material Support
|
| Central Pharmacy, HI Tech 5th Floor , Dr. D. Y. Patil Medical College Hospital And Research Centre, Sant Tukaram Nagar, Pimpri, Pune, Maharashtra, India, Pincode 411018 |
|
|
Primary Sponsor
|
| Name |
Dr Anushka Sharma |
| Address |
Department of Anesthesiology 5th floor , HI tech building, DR.DY.PATIL MEDICAL COLLEGE, HOSPITAL AND RESEARCH CENTRE , sant Tukaram Nagar, Pimpri, Pune, , Maharashtra, India, pincode 411018 |
| 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 Anushka sharma |
Dr.D.Y. Patil medical college, hospital and research centre |
5th floor, HI tech building department of Anesthesiology, Dr.D.Y. Patil medical college, hospital and research centre, Sant Tukaram Nagar, Pimpri,Pune 411018 Pune MAHARASHTRA
Pune
MAHARASHTRA |
7772979608
Anushka.as.Sharma.2898@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Subcommittee, dr DY Patil medical college Pune |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K00-K95||Diseases of the digestive system, (2) ICD-10 Condition: R00-R99||Symptoms, signs and abnormal clinical and laboratory findings, not elsewhere classified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
DEXAMETHASONE |
DEXAMETHASONE 8mg (0.4mg/kg) given in transverse abdominal plane block as an adjuvant to inj bupivacaine 0.5% |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
3.00 Year(s) |
| Age To |
16.00 Year(s) |
| Gender |
Both |
| Details |
1. ASA grade I or II fit patients.
2. Patients aged between 3 and 16 years of age.
3. Patients undergoing surgeries under general anaesthesia.
4. Written informed consent from the concerned patient. |
|
| ExclusionCriteria |
| Details |
1. ASA grade III or IV patients.
2. Patients with a history of developmental delay or mental retardation affecting observational pain intensity assessment,
3. hypersensitivity to any local anaesthetics,
4. bleeding abnormalities. infection signs at the injection site of the desired block.
5. Patient/parent refusal.
6. Patients with bilateral, obstructed, or strangulated hernias. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| to evaluate the duration of postoperative analgesia after adding dexamethasone to bupivacaine on the quality of Ultrasound-guided Transverse Abdominis Plane block in children undergoing appendecectomy . |
1year and 6 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To study the efficacy of using inj dexamethasone as an adjuvant to inj bupivacaine0.25% in TAP block in children.
• Post operative compare Hemodynamic parameters.
• First rescue analgesia.
• Total number of rescue analgesic post operatively used in 24 hrs. |
Within 6 hours of block given |
|
|
Target Sample Size
|
Total Sample Size="84"
Sample Size from India="84"
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)
|
18/12/2024 |
| 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="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| 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
|
It is a prospective observational study to evaluate the efficacy of inj defame that’s one as an adjuvant to inj bupivacaine in ultrasound guided transverse abdominus plane block in children undergoing appendicectomy surgeries.
By this study we want to see the comparison between plane normal saline and inj dexamethasone efficacy in the block by assessing the pain scores after the surgery. |