| CTRI Number |
CTRI/2017/04/008341 [Registered on: 12/04/2017] Trial Registered Retrospectively |
| Last Modified On: |
10/04/2017 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparison between two methods of pain relief after Hernia surgery in children. |
|
Scientific Title of Study
|
Comparison of Ultrasound Guided Transversus Abdominis Plane Block and Caudal Epidural Block for pain relief in children undergoing Unilateral Inguinal Herniotomy |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Ayshvarya |
| Designation |
Resident |
| Affiliation |
K.A.P.V. Government Medical College |
| Address |
Department of Anaesthesia,
Mahatma Gandhi Memorial Government Hospital
Tamil Nadu - 620001
Tiruchirappalli
TAMIL NADU
620003
India |
| Phone |
9710413083 |
| Fax |
04312411012 |
| Email |
aysh88@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Selvakumar Rajasekaran |
| Designation |
Professor |
| Affiliation |
Mahatma Gandhi Memorial Government Hospital, Trichy |
| Address |
Mahatma Gandhi Memorial Government Hospital,
Puthur, Thillai Nagar, Tiruchirappalli, Tamil Nadu
Dr.Selvakumar Rajasekaran
Jyothi Nivas, 6, J.N.Nagar, 5th street, Valluvar Colony, Madurai- 625017
Tiruchirappalli
TAMIL NADU
620017
India |
| Phone |
9842165067 |
| Fax |
|
| Email |
drselvakumar@rediffmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Ayshvarya |
| Designation |
Resident |
| Affiliation |
K.A.P.V. Government Medical College |
| Address |
Department of Anaesthesia,
Mahatma Gandhi Memorial Government Hospital
Tamil Nadu - 620001
Department of Anaesthesia,
Mahatma Gandhi Memorial Government Hospital
Tamil Nadu - 620001
Tiruchirappalli
TAMIL NADU
620003
India |
| Phone |
9710413083 |
| Fax |
|
| Email |
aysh88@gmail.com |
|
|
Source of Monetary or Material Support
|
| K.A.P.V.Government Medical College and Mahatma Gandhi Memorial Government Hospital, Trichy |
|
|
Primary Sponsor
|
| Name |
Mahatma Gandhi Memorial Government Hospital |
| Address |
Puthur, Thillai Nagar, Tiruchirappalli, Tamil Nadu 620017 |
| 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 Selvakumar R |
Mahatma Gandhi Memorial Government Hospital, Thillai Nagar, Puthur, Trichy- 620017 |
Room No.16, Department of Anaesthesia, Specialty Theatre Division.
Tiruchirappalli
TAMIL NADU |
9842165067
drselvakumar@rediffmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| K.A.P.Viswanatham Govt. Medical College, Tiruchirapalli-1, Institutional ethical committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
undergoing unilateral inguinal herniotomy for circumscision, congential hernia, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Caudal epidural block |
Depositing local anaesthetic in caudal space for anaesthesia |
| Intervention |
Transversus Abdominis Plane Block under ultrasound guidance |
Depositing local anaesthetic between two muscles where nerves of the abdominal wall traverse. |
|
|
Inclusion Criteria
|
| Age From |
1.00 Year(s) |
| Age To |
7.00 Year(s) |
| Gender |
Both |
| Details |
1. Children weighing 5-20kg
2. Children belonging to ASA Physical status I & II
3. Children undergoing elective inguinal herniotomy
4. Children undergoing unilateral surgery |
|
| ExclusionCriteria |
| Details |
1. Children undergoing bilateral Inguinal Herniotomy
2. children belonging to ASA status III, IV,
3. Children of age less than 2yrs or more than 7yrs, excluded
4. Children weighing less than 5 kg or more than 20kg
5. Children with known allergy to the drugs used in the study
6. chidren with any local infection at the site of the block
7. Children with any contraindications for caudal anaesthesia such as major sacral malformations, meningitis, raised intracranial hypertension
8. Parent refusal for consent were excluded from the study |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Participant, Investigator and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Pain assessment in the post-operative period was done using FLACC pain score. |
Children were monitored during the time points;
1. immediate post-operative period in the recovery room
2. every hour for the first 12hrs in the post-operative period |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
• Intraoperative parameters measured:
1. Haemodynamic variability
2. Number of doses of fentanyl (1mcg/kg) required for supplementation during the intra-operative period.
3. Incidence of any adverse events
Postoperative parameters measured:
1. Number of doses of rescue analgesia required .
2. Cumulative dose of tramadol consumed
3. Incidence of any side effects |
every 5mins in the intraoperstive period and every hour in the post operative period |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
Final Enrollment numbers achieved (Total)= ""
Final Enrollment numbers achieved (India)="" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
27/12/2015 |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
None yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
To evaluate the efficacy of the Ultrasound-guided
Transversus Abdominis Plane Block in comparison with the Caudal Epidural Block,
for pain relief in paediatric inguinal hernia repair surgeries
Methodology:
Sixty patients belonging to the age group 1-7years, weighing 5-20kg
undergoing unilateral inguinal herniotomy were randomly allocated into two
groups. Group T (n=30) received USG-guided TAP block with 0.5ml/kg of 0.25%
bupivacaine and Group C (n=30) received 1ml/kg of 0.25% bupivacaine, after
institution of general anaesthesia via ambu LMA. The intra-operative
hemodynamics and analgesic requirement were recorded by a blinded investigator.
Pain in the post-operative period was
assessed using FLACC pain score. Time to first rescue analgesia, cumulative
opioid consumption, along with the incidence of side effects were noted in the
first 12hrs of the post-operative period |