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CTRI Number  CTRI/2012/01/002387 [Registered on: 31/01/2012] Trial Registered Prospectively
Last Modified On: 01/10/2013
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Surgical/Anesthesia 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Comparison of two techniques For Pain Relief In Children Undergoing Lower Abdominal Surgery 
Scientific Title of Study   Comparison of Caudal Epidural Block and Ultrasound Guided Transversus Abdominis Plane Block For Pain Relief In Children Undergoing Lower Abdominal Surgery 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Nitin Sethi 
Designation  Associate Consultant 
Affiliation  Department of Anaesthesiology Pain and Perioperative Medicine Sir Ganga Ram Hospital  
Address  Sir Ganga Ram Hospital Old Rajinder Nagar
Sir Ganga Ram hospital Old Rajinder Nagar
New Delhi
DELHI
121007
India 
Phone  09717494498  
Fax  01125861002  
Email  nitinsethi77@yahoo.co.in  
 
Details of Contact Person
Scientific Query  
Name  Dr Nitin Sethi 
Designation  Associate Consultant 
Affiliation  Department of Anaesthesiology Pain and Perioperative Medicine Sir Ganga Ram Hospital  
Address  Sir Ganga Ram Hospital Old Rajinder Nagar
Sir Ganga Ram hospital Old Rajinder Nagar
New Delhi
DELHI
121007
India 
Phone  09717494498  
Fax  01125861002  
Email  nitinsethi77@yahoo.co.in  
 
Details of Contact Person
Public Query  
Name  Dr Nitin Sethi 
Designation  Associate Consultant 
Affiliation  Department of Anaesthesiology Pain and Perioperative Medicine Sir Ganga Ram Hospital  
Address  Sir Ganga Ram Hospital Old Rajinder Nagar
Sir Ganga Ram hospital Old Rajinder Nagar
New Delhi
DELHI
121007
India 
Phone  09717494498  
Fax  01125861002  
Email  nitinsethi77@yahoo.co.in  
 
Source of Monetary or Material Support  
Department of Anaesthesiology Pain and Perioperative Medicine Sir Ganga Ram Hospital Old Rajinder Nagar New Delhi 
 
Primary Sponsor  
Name  Department of Anaesthesiology Pain and Perioperative Medicine  
Address  Sir Ganga Ram Hospital, Old Rajinder Nagar ,New Delhi 
Type of Sponsor  Research institution and hospital 
 
Details of Secondary Sponsor  
Name  Address 
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 Nitin Sethi  Department of Anaesthesiology Pain & Periopertive Medicine Sir Ganga Ram Hospital  Old Rajinder Nagar New Delhi 110060
New Delhi
DELHI 		 09717494498
01125861002
nitinsethi77@yahoo.co.in 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Ethics Committee Sir Ganga Ram Hospital  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  Unilateral lower abdominal surgery such as hernia repair, orchidopexy,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  1. Caudal epidural block  Children will receive caudal epidural block after induction of anaesthesia. The epidural space will be identified with the loss of resistance technique with a 23 G hypodermic needle and 0.75 ml/kg of 0.25% bupivacaine will be injected. 
Intervention  2.Ultrasound guided Transversus Abdominus plane block  Children in will receive ultrasound guided transversus abdominis plane block after induction of anaesthesia. A 5-13 Mhz ultrasound probe (Sonosite) will be positioned transversely on the abdominal wall between the costal margin and the iliac crest in the anterior axillary line. A 22 G 50mm blunt needle will be inserted a few centimeters medial to the probe and then advanced under the probe. The needle will be advanced till it reaches the plane between the internal oblique and the transversus abdominis muscle and 0.5 ml/kg of 0.25% bupivacaine will be injected.  
Comparator Agent  nil  nil 
 
Inclusion Criteria  
Age From  2.00 Year(s)
Age To  6.00 Year(s)
Gender  Both 
Details  1.ASA physical status I or II
2.unilateral lower abdominal surgeries such as hernia repair, orchidopexy under general anaesthesia  
 
ExclusionCriteria 
Details  1.Children undergoing bilateral lower abdominal surgery.
2.Children with known allergy to bupivacaine.
3.Children undergoing additional surgical procedure at anatomical location not covered by either transversus abdominis plane block or caudal block.
4.Children with history of renal or hepatic insufficiency
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant, Investigator and Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
1. Duration of postoperative analgesia: It will be defined as the time interval beginning from the end of anaesthesia to the time the child has a FLACC score 3  From begining of anaesthesia till first 24 hours postoperatively 
 
Secondary Outcome  
Outcome  TimePoints 
1. Quality of pain relief in the first 24 hours postoperatively evaluated using the FLACC scale.
2. Amount of rescue analgesia administered.
3. Incidence of side effects such as bradycardia, hypotension, respiratory depression, nausea /vomiting and urinary retention

 		 From begining of anaesthesia till first 24 hours postoperatively 
 
Target Sample Size   Total Sample Size="80"
Sample Size from India="80" 
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   N/A 
Date of First Enrollment (India)   15/02/2012 
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="11"
Days="30" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Open to Recruitment 
Publication Details    
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Brief Summary  

Caudal epidural block is the most commonly performed regional block in paediatric anaesthesia for providing intraoperative and postoperative analgesia after lower abdominal and perineal surgeries.  Although the efficacy and safety of this technique is high, it has certain disadvantages such as unwarranted motor blockade of the lower limbs and disturbance of bladder function.The limitation of caudal block when administered  as a ‘single- shot technique’ is its limited duration of action, about 4-6 hours post block, making administration of additional pain medicine necessary.

Peripheral nerve blocks are alternative to caudal block with a lower incidence of side effects and a prolonged duration of analgesia. The nerves that supply the abdominal wall (T7-L1) course through the neurofascial plane between the internal oblique and the transversus abdominis muscle. The blockade of nerves in this location is known as the transversus abdominis plane block (TAP block). Ultrasound guided technique improves the margin of safety due to better localization and deposition of local anaesthetic with improved accuracy. Ultrasound guided transversus abdominis plane (TAP) block has been described in children undergoing lower abdominal and laparoscopic surgery. However, there are only few randomized clinical trials regarding use of ultrasound guided TAP block in children.

In the present study we want to compare the efficacy of ultrasound guided transversus abdominis plane (TAP) block and caudal block for providing postoperative pain relief in children undergoing lower abdominal surgeries.

 

 

 


 
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