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
|
|
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
|
|
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.
|