FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
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  
Nil 
 
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  
Name  Address 
NIL  NIL 
 
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  
Status 
Not Applicable 
 
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.

 
Close