FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2023/02/049738 [Registered on: 15/02/2023] Trial Registered Prospectively
Last Modified On: 14/02/2023
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   To compare which one,out of dexamethasone and clonidine provides better pain relief when added as an additive in transversus abdominis plane block 
Scientific Title of Study   A randomised controlled trial to compare the efficacy of clonidine versus dexamethasone as an adjunct in ultrasound guided transversus abdominis plane block in children undergoing laparotomy 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Jyotsana Arora 
Designation  Post graduate student  
Affiliation  Lady Hardinge Medical College 
Address  Department of anaesthesia,Lady Hardinge Medical College
Shaheed Bhagat Singh Marg,New Delhi, DELHI-110001 India
Central
DELHI
110001
India 
Phone  8826474790  
Fax    
Email  jyotsnaarora17@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Ranju Singh 
Designation  Director Professor 
Affiliation  Lady Hardinge Medical College 
Address  Department of anaesthesia,Lady Hardinge Medical College
Shaheed Bhagat Singh Marg,New Delhi, DELHI-110001 India
Central
DELHI
110001
India 
Phone  9811151285  
Fax    
Email  ranjusingh1503@yahoo.com  
 
Details of Contact Person
Public Query
 
Name  Jyotsana Arora 
Designation  Post graduate student 
Affiliation  Lady Hardinge Medical College 
Address  Department of anaesthesia,Lady Hardinge Medical College
Shaheed Bhagat Singh Marg,New Delhi, DELHI-110001 India
Central
DELHI
110001
India 
Phone  8826474790  
Fax    
Email  jyotsnaarora17@gmail.com  
 
Source of Monetary or Material Support  
Department of Anaesthesia,Lady Hardinge Medical College, Connaught place , New delhi, Delhi-110001 
 
Primary Sponsor  
Name  Lady Hardinge Medical College 
Address  Department of Anaesthesia,Lady Hardinge Medical College,Shaheed Bhagat Singh Marg,New Delhi 
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 
Jyotsana Arora  Lady Hardinge Medical College  Department of Anaesthesia,Shaheed Bhagat Singh Marg
Central
DELHI 
8826474790

jyotsnaarora17@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Ethics Committee for Human Research  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: K00-K95||Diseases of the digestive system,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Clonidine  0.25% levobupivacaine with clonidine 2 μg/Kg with a total volume of 0.5mL/Kg 
Comparator Agent  Dexamethasone  0.25% levobupivacaine with dexamethasone 0.1mg/Kg, with a total volume of 0.5mL/Kg 
Intervention  Ultrasound Guided Transversus Abdominis Plane Block  To compare the efficacy of clonidine versus dexamethasone as an adjunct in ultrasound guided transversus abdominis plane block in children undergoing laparotomy 
 
Inclusion Criteria  
Age From  1.00 Year(s)
Age To  8.00 Year(s)
Gender  Both 
Details  Patients of either sex, belonging to age group 1-8 years, scheduled for laparotomy 
 
ExclusionCriteria 
Details  1. History of any relevant drug allergy or chronic pain
2. Coagulation disorder
3. Infection at the needle insertion site
4. Duration of surgery > 3 hours
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded 
Primary Outcome  
Outcome  TimePoints 
Mean duration of postoperative analgesia (in hours) in children receiving clonidine or dexamethasone as an adjunct in TAP block for laparotomy

 
at the end of study

 
 
Secondary Outcome  
Outcome  TimePoints 
1. Mean (±SD) requirement of analgesics (μg) in 24 hours postoperatively
2. Median [ Interquartile range (IQR)] CHEOPS at 30 minute, 3 hours, 6 hours, 12 hours, and 24 hours postoperatively
3. Proportion of patients developing side effects of the drugs - clonidine or dexamethasone (dry mouth, hypotension, bradycardia)
4. Median (IQR) University of Michigan Sedation Score (UMSS) at 30 minutes, 3 hours, 6 hours, 12 hours and 24 hours interval.
5.Median (IQR) parental satisfaction score (Likert scale) at 24 hours postoperatively
 
1.24 hours postoperatively
2.30 minute, 3 hours, 6 hours, 12 hours, and 24 hours postoperatively
4. 30 minute, 3 hours, 6 hours, 12 hours, and 24 hours postoperatively
5.24 hours postoperatively
 
 
Target Sample Size   Total Sample Size="70"
Sample Size from India="70" 
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)   23/02/2023 
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="5"
Days="0" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   NIL 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary  

INTRODUCTION

Postoperative pain relief is an essential component of modern anaesthesia practice that greatly reduces the stress response of surgery and the perioperative morbidity in surgical patients. With the greater availability of portable ultrasound (USG) in recent years, a surge in the use of regional blocks for management of postoperative pain is evident. The use of USG guidance allows real-time visualisation of anatomical structures and shows the spread of anaesthetic solution injected. This is an attractive option in paediatric patients as most regional anaesthetic techniques are performed while under general anaesthesia. Evidence-based literature shows that USG guided regional blocks provide better postoperative pain control, reduce opioid requirements, decrease hospital stay and improve outcomes in paediatric patients1. Therefore, USG guided regional blocks are becoming the standard of care for postoperative pain relief in paediatric patients2.

 Peripheral nerve blocks are usually favoured over central neuraxial blocks as they cause minimal haemodynamic alterations and complications, as well as short hospital stay.  The transversus abdominis plane (TAP) block is one of the most popular peripheral nerve blocks and provides adequate postoperative analgesia for a range of abdominal procedures by blocking the lower intercostal (T6-11) nerves, ilioinguinal, and iliohypogastric nerves3,4. Local anaesthetic agents (LA) are deposited in the neurovascular plane between the internal oblique and transversus abdominis muscle. The transversus abdominis plane block has been given with LAs like bupivacaine and ropivacaine but they have a limited duration of action. Adjuvant drugs are often added to LAs in peripheral blocks to achieve a quick, dense and prolonged block5. Alpha 2 agonists, like clonidine and dexmedetomidine are commonly added to LAs in TAP block6. Their clinical use is however limited by the occurrence of hypotension and bradycardia which can be detrimental in small children in the postoperative period. Dexamethasone, a very potent and highly selective glucocorticoid has also been used an adjuvant to LAs in various nerve blocks resulting in a prolonged duration of analgesia and motor block. Dexamethasone helps by attenuating the release of inflammatory mediators, reducing ectopic neuronal discharge and inhibiting potassium channel-mediated discharge of nociceptive C-fibres. Addition of steroids to LAs effectively and significantly prolongs the duration of analgesia as well as producing earlier onset of action7.

                       

 

                                     RATIONALE FOR STUDY

Transversus abdominis plane block has emerged as a safe, reliable and efficient technique to provide postoperative analgesia for a range of abdominal procedures. Although many studies have described the successful usage of TAP block and the use of adjuncts for the same in adults, no data is available regarding the use of adjuncts such as dexamethasone or clonidine in TAP block in paediatric patients. Thus, the present study is aimed to compare the efficacy (in terms of duration of postoperative analgesia) of clonidine with dexamethasone as an adjunct in ultrasound guided TAP block in children undergoing laparotomy.

    

 
Close