| CTRI Number |
CTRI/2020/06/025695 [Registered on: 08/06/2020] Trial Registered Prospectively |
| Last Modified On: |
06/06/2020 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Pain blocks in children undergoing laproscopic appendicectomy |
|
Scientific Title of Study
|
Comparing the intraoperative and postoperative analgesic effect of transabdominal block versus caudal block in children undergoing laproscopic appendicectomy |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Saraswathi Nagapaa |
| Designation |
Assistant professor |
| Affiliation |
Bangalore medical college and research institute |
| Address |
Anaesthesiology department,Superspeciality block(PMSSY), BMCRI
Bangalore
Bangalore
KARNATAKA
560002
India |
| Phone |
09663304834 |
| Fax |
|
| Email |
dr.saraswathi.pmssy@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Saraswathi Nagapaa |
| Designation |
Assistant professor |
| Affiliation |
Bangalore medical college and research institute |
| Address |
Anaesthesiology department,Superspeciality block(PMSSY), BMCRI
Bangalore
KARNATAKA
560002
India |
| Phone |
09663304834 |
| Fax |
|
| Email |
dr.saraswathi.pmssy@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Saraswathi Nagapaa |
| Designation |
Assistant professor |
| Affiliation |
Bangalore medical college and research institute |
| Address |
Anaesthesiology department,Superspeciality block(PMSSY), BMCRI
Bangalore
KARNATAKA
560002
India |
| Phone |
09663304834 |
| Fax |
|
| Email |
dr.saraswathi.pmssy@gmail.com |
|
|
Source of Monetary or Material Support
|
| Super specialty hospital(PMSSY), Anaesthesiology department,Bangalore medical
college and research institute |
|
|
Primary Sponsor
|
| Name |
Anaesthesiology department |
| Address |
Super speciality block(PMSSY), Bangalore medical college and research institute |
| Type of Sponsor |
Research institution and hospital |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Dr Nethra H N |
Assistant professor
Anaesthesiology department, Super speciality block, Bangalore medical college and research institute |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Saraswathi N |
Super speciality block PMSSY, Bangalore medical college and research institute |
Anaesthesiology department,
Bangalore
KARNATAKA |
09663304834
dr.saraswathi.pmssy@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Bangalore medical college and research institute |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K358||Other and unspecified acute appendicitis, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Caudal block and tansverse abdominal block in children undergoing appendectomy |
Caudal block and Tansverse abdominal block in laproscopic guided appendectomy using 0.2/ Ropivacain drugs |
| Comparator Agent |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
12.00 Year(s) |
| Age To |
18.00 Year(s) |
| Gender |
Both |
| Details |
Posted for elective laproscopic appendicectomy |
|
| ExclusionCriteria |
| Details |
Patient refusal
Allergy to local anaesthetics
Localised infection over injection point
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Consumption of opoids intraoperative and postoperatively |
Consumption of opoids during incision,pnemopertonium.Rescue analgesia postoperatively 24 hrs duration at 30min,60min,120min,240min,480min,720min and 1440min |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Haemodynamic parameters during intraorative and postoperative |
Haemodynamic parameters during surgery lasting less than 2 hrs and postoperatively for 24hrs,at 30 min,60min,120min,240min,480min,720min and 1440min |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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 1 |
|
Date of First Enrollment (India)
|
10/06/2020 |
| 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="1"
Days="2" |
|
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)?
|
|
Brief Summary
|
Today caudal analgesia in pediatric has increased , because it is complementary to general Anaesthesia,allows conscious postoperative analgesia without respiratory depression. Transverse abdominis a plane block is safe efficient and alternative regional Anaesthesia for postoperative analgesia in abdominal surgery. |