CTRI Number |
CTRI/2017/06/008729 [Registered on: 01/06/2017] Trial Registered Retrospectively |
Last Modified On: |
19/02/2024 |
Post Graduate Thesis |
No |
Type of Trial |
Interventional |
Type of Study
|
Surgical/Anesthesia |
Study Design |
Randomized, Parallel Group, Active Controlled Trial |
Public Title of Study
|
Comparison of sonography guided abdominal nerves block versus local injection for postoperative pain relief in key hole surgeries in children |
Scientific Title of Study
|
Randomised prospective study of comparison of ultrasound guided transversus abdominis plane (TAP) block versus local infiltration during paediatric laparoscopic surgeries |
Trial Acronym |
|
Secondary IDs if Any
|
Secondary ID |
Identifier |
NIL |
NIL |
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
Name |
Nandini Malay Dave |
Designation |
Additional professor |
Affiliation |
Seth G.S.Medical college and KEM hospital |
Address |
C-303, Presidential Towers, LBS marg, Ghatkopar west, Mumbai. Seth G.S.Medical college and KEM hospital, Acharya Donde marg, Parel, Mumbai-400012 Mumbai MAHARASHTRA 400086 India |
Phone |
9819392094 |
Fax |
|
Email |
nandinidave@gmail.com |
|
Details of Contact Person Scientific Query
|
Name |
Priyanka Pradeep Karnik |
Designation |
Senior resident |
Affiliation |
Seth G.S.Medical college and KEM hospital |
Address |
B-404, Om Deep Sai Pooja CHS, Dr. Lazarus road, Charai Naka, Thane west Seth G.S.Medical college and KEM hospital,Acharya Donde marg, Parel, Mumbai-400012 Mumbai MAHARASHTRA 400602 India |
Phone |
9819390592 |
Fax |
|
Email |
drpriyankakarnik@gmail.com |
|
Details of Contact Person Public Query
|
Name |
Priyanka Pradeep Karnik |
Designation |
Senior resident |
Affiliation |
Seth G.S.Medical college and KEM hospital |
Address |
B-404, Om Deep Sai Pooja CHS, Dr. Lazarus road, Charai Naka, Thane west Seth G.S.Medical college and KEM hospital,Acharya Donde marg, Parel, Mumbai-400012 Mumbai MAHARASHTRA 400602 India |
Phone |
9819390592 |
Fax |
|
Email |
drpriyankakarnik@gmail.com |
|
Source of Monetary or Material Support
|
|
Primary Sponsor
|
Name |
Department of Anaesthesia Seth GS medical college and KEM hospital |
Address |
Department of Anaesthesia Seth GS medical college and KEM hospital, 1st floor, Acharya Donde Marg, Parel, Mumbai. 400012 |
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 Nandini Dave |
Seth G.S. medical college |
3rd floor, Paediatric surgery operation theatre, near ward 3, KEM hospital, Acharta Donde marg, Parel, Mumbai. 400012 Mumbai MAHARASHTRA |
9819392094
nandinidave@gmail.com |
|
Details of Ethics Committee
|
No of Ethics Committees= 1 |
Name of Committee |
Approval Status |
Institutional Ethics Committee |
Approved |
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
Modification(s)
|
Health Type |
Condition |
Patients |
(1) ICD-10 Condition: K80||Cholelithiasis, (2) ICD-10 Condition: Q531||Undescended testicle, unilateral, (3) ICD-10 Condition: K409||Unilateral inguinal hernia, without obstruction or gangrene, (4) ICD-10 Condition: K36||Other appendicitis, |
|
Intervention / Comparator Agent
|
Type |
Name |
Details |
Intervention |
Group A. |
Bilateral USG guided Transversus abdominis plane block |
Comparator Agent |
Group B |
Local infiltration |
|
Inclusion Criteria
|
Age From |
2.00 Year(s) |
Age To |
12.00 Year(s) |
Gender |
Both |
Details |
1.ASA I and II patients posted for elective laparoscopic surgeries in Paediatric surgery OT
2.Age between 2-12 years of both sexes
3.Children undergoing laparoscopic appendicectomy, hernia repair, cholecystectomy, and orchidopexy.
|
|
ExclusionCriteria |
Details |
1.Refusal by the parent to participate in the study
2.Children in whom TAP block is contraindicated i.e. surgical scar or distorted anatomy at the site of injection.
3.Children with known allergy to local anaesthetics.
4.Children with known cardiovascular, respiratory, hepatic or renal disease
5.Laparoscopy converted to open surgery
|
|
Method of Generating Random Sequence
|
Random Number Table |
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
Blinding/Masking
|
Participant and Investigator Blinded |
Primary Outcome
|
Outcome |
TimePoints |
Pain relief |
The pain score will be assessed at 10min, 30mins, 1hour and hourly thereafter up to 6 hours post operatively |
|
Secondary Outcome
|
Outcome |
TimePoints |
Opioid Requirement |
intraoperatively |
Intraoperative Hemodynamics |
at 5, 15, 30, 45 and 60 mins Intraoperatively |
|
Target Sample Size
|
Total Sample Size="72" Sample Size from India="72"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="72" |
Phase of Trial
|
N/A |
Date of First Enrollment (India)
|
10/04/2017 |
Date of Study Completion (India) |
19/08/2018 |
Date of First Enrollment (Global) |
Date Missing |
Date of Study Completion (Global) |
Date Missing |
Estimated Duration of Trial
|
Years="0" Months="6" Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
Recruitment Status of Trial (India) |
Completed |
Publication Details
Modification(s)
|
published |
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
|
SUMMARY
Although
abdominal laparoscopic surgery is known for less pain compared to that of
laparotomy, many patients actually still complain of considerable postoperative
pain. Pain after laparoscopic surgeries is caused by the incision and
visceroperitoneal pain due to peritoneal stretch and inflammation. A promising
approach to the provision of postoperative analgesia after abdominal surgery is
to block the sensory nerve supply to the anterior abdominal wall by placing a
local anaesthetic in the transversus abdominis plane. The TAP block was first
described by McDonell and colleagues in 2004 and a USG guided technique was
subsequently described by Hebbard and colleagues. USG guided TAP block provides
excellent pain relief in lower abdominal surgeries. The purpose of this study
is to evaluate the analgesic efficacy of USG guided TAP block in children
undergoing laparoscopic surgeries.
After
obtaining ethical clearance from the institutional review board, the study will
be carried out in 72 patients posted for laparoscopic surgeries like hernia
repair, orchidopexy, appendicectomy and cholecystectomy in Paediatric Surgery
OT. The patients will be divided into two groups after induction of
anaesthesia:
Group A: Patients will receive bilateral TAP block under USG
guidance using 0.4ml/kg 0.25% Inj. Bupivacaine.
Group B: Patients will receive local infiltration at the port
using 0.4ml/kg 0.25% Inj. Bupivacaine.
Inj Paracetamol 15mg/kg will be given intravenously in both
groups at the beginning of surgery. Parameters recorded will be: Intraoperatively
hemodynamics i.e. heart rate and blood pressure monitoring every 15minutes and
total dose of opioid required. Postoperatively assessment of pain: Wong Baker
FACES scale, duration of analgesia and adverse effects. The
pain score will be assessed at 10min, 30mins, 1hour and hourly thereafter up to
6 hours post operatively.
Inj. Diclofenac 1.5mg/kg will be given as rescue analgesic post operatively if
the Wong Baker’s FACES score is more than 4.
Statistical analysis: Statistical analysis of the
demographic data will be done using Chi-square test. The continuous outcomes
will be measured using the Student’s t test or the Mann Whitney U test. A p
value<0.05 will be considered significant. |