| CTRI Number |
CTRI/2025/07/090587 [Registered on: 09/07/2025] Trial Registered Prospectively |
| Last Modified On: |
08/07/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Multiple Arm Trial |
|
Public Title of Study
|
comparison of three methods of pain relief by injecting 0.2 percent local anesthetic at tail bone ,side of belly and at surgical site in children posted for keyhole abdominal surgery. |
|
Scientific Title of Study
|
Comparison of caudal epidural block 0.2 percentage ropivacaine, transverse abdominis plane block 0.5ml per kg of 0.2 percentage ropivacaine and port site infiltration of 0.4ml per kg of 0.2 percent ropivacaine for postoperative analgesia in pediatric laparoscopic 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 Aayushi Singh |
| Designation |
Post graduate student |
| Affiliation |
IMS and SUM Hospital |
| Address |
Department of Anaesthesiology and Critical care, first floor, IMS and
SUM Hospital, Siksha O Anusandhan, K8, Kalinga Nagar,
Bhubaneshwar
Khordha
ORISSA
751003
India
Khordha
ORISSA
751003
India |
| Phone |
7300872343 |
| Fax |
|
| Email |
aayushisingh@soa.ac.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sulochana Dash |
| Designation |
Professor |
| Affiliation |
IMS and SUM Hospital |
| Address |
Department of Anaesthesiology and Critical care, first floor, IMS and
SUM Hospital, Siksha O Anusandhan, K8, Kalinga Nagar,
Bhubaneshwar
Khordha
ORISSA
751003
India
Khordha
ORISSA
751003
India |
| Phone |
9566841303 |
| Fax |
|
| Email |
dr.silu76@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sulochana Dash |
| Designation |
Professor |
| Affiliation |
IMS and SUM Hospital |
| Address |
Department of Anaesthesiology and Critical care, first floor, IMS and
SUM Hospital, Siksha O Anusandhan, K8, Kalinga Nagar,
Bhubaneshwar
Khordha
ORISSA
751003
India
ORISSA
751003
India |
| Phone |
9566841303 |
| Fax |
|
| Email |
dr.silu76@gmail.com |
|
|
Source of Monetary or Material Support
|
| Institute of medical Sciences and SUM Hospital, Siksha O Anusandhan, Bhubaneswar, Khordha,
Odisha, India, Pin 751003
|
|
|
Primary Sponsor
|
| Name |
Institute of medical Sciences and SUM Hospital |
| Address |
K8 kalinganagar bhubaneshwar odisha 751003 India
|
| Type of Sponsor |
Private 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 Aayushi Singh |
Institute of Medical Sciences and SUM Hospital, Siksha O Anusandhan |
Department of
Anaesthesiology,Paediatric OT in Modular 3 complex, first
floor, Institute of
medical Sciences and
SUM Hospital, Siksha
O Anusandhan,
Bhubaneswar,
Khordha, Odisha, India,
Pin 751003
Khordha
ORISSA
Khordha
ORISSA |
7300872343
aayushisingh@soa.ac.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, IMS and SUM Hospital, Bhubaneswar |
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 |
Caudal epidural block |
Caudal block involves palpation, identification and placing a needle through the sacral hiatus and delivering 0.2 % Ropivacaine at a dose as per Green Armitage formula into the epidural space and then recording the post-operative analgesia using visual analog scale at 0,3,5,10,15,24 hours. |
| Comparator Agent |
Port site infiltration |
Port site infiltration of 0.4ml/kg of 0.2% Ropivacaine at port site at the end of the surgery and then recording the post-operative analgesia using visual analog scale at 0,3,5,10,15,24 hours. |
| Intervention |
Transverse abdominis plane block |
Transverse abdominis plane block involves USG guided injecting of 0.5 ml /kg of 0.2% Ropivacaine in between the transverse abdominis and internal oblique muscles containing T6 to L1 thoraco-lumbar nerves providing somatic analgesia and then recording the post-operative analgesia using visual analog scale at 0,3,5,10,15,24 hours. |
|
|
Inclusion Criteria
|
| Age From |
5.00 Year(s) |
| Age To |
10.00 Year(s) |
| Gender |
Both |
| Details |
children between 5 to 10 years undergoing laparoscopic abdominal surgeries whose parents or legal guardians have given consent |
|
| ExclusionCriteria |
| Details |
1. Coagulation disorder
2. Known allergy to Ropivacaine
3.Spinal malformations like spina bifida,meningomyeloceles
4. Infections at the site of block administration |
|
|
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 post-operative analgesia using VAS scale at 0,3,5,10,15,24 hours between the 3 study groups.
2.To compare Time, frequency and total dose of first rescue analgesia in the post operative period.
|
0,3,5,10,15,24 hours |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To compare the side effects of the three modes of analgesia. |
0,3,5,10,15,24 hours |
|
|
Target Sample Size
|
Total Sample Size="105"
Sample Size from India="105"
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 4 |
|
Date of First Enrollment (India)
|
30/07/2025 |
| 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
|
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 is a prospective randomised clinical controlled study which will be conducted at IMS & SUM Hospital with a study population of 105 patients consisting of ASA1 & ASA 2, age group 5 -10 years posted for elective laparoscopic abdominal surgeries .
Proper consent and all the details about the procedure will be thoroughly explained to the parents and the patient.
All patients will be thoroughly examined preoperatively which includes history,general physical examination, the pre-op vitals of the patient such as blood pressure, pulse, respiratory rate, ASA grading and systemic examination.
All the patients will be nil per oral for at least 6 hours for solid,4 hours for liquid and 2 hours for clear fluid.
The routine monitors will be attached and all the preoperative baseline readings of non invasive blood pressure (NIBP),pulse rate (PR) and saturation (SP02) will be noted.
After securing an intravenous access , all the patients irrespective of the group they belong will be preloaded according to holiday segar formula with IV DNS.
Inj midazolam 0.05 mg /kg will be given as premedicaton.Inj fentanyl 2mcg/kg IV given. Induction will be done with sevoflurane. Endotracheal intubation or LMA will be put depending upon the surgery. Pressure-controlled ventilation and low fresh gas flows will be used.
GROUP CEB: candidates will be administered caudal block of 0.2% Ropivacaine at a dose decided by green Armitage formula at the sacral hiatus using USG and then confirmed by whoosh test.
GROUP TAP :candidates will be given transverse abdominal plane block under USG using 0.5ml/kg of 0.2% Ropivacaine.
GROUP PSI: candidates will be given port site infiltration of about of 0.2% Ropivacaine 0.4ml/kg given at the end of surgery at port site.
After the completion of surgery, Patient will be shifted to post anesthetic care unit.
Now all the three groups will be compared using the visual analog scale at post anesthetic care unit at interval of 0 hours,3hours, 5 hours,10 hours,15hours and 24 hours.
Along with this, time at which rescue analgesia will be required and total dose of rescue analgesia which will be required will be noted.
The post operative side effects like hypotension and urinary retention will be compared across the three groups.
Rescue analgesia(Inj paracetamol 15mg/kg IV) will be given after VAS Score >3 and if no improvement observed (inj tramadol 1-3mg/kg IV) slowly will be given.
|