| CTRI Number |
CTRI/2018/06/014429 [Registered on: 05/06/2018] Trial Registered Prospectively |
| Last Modified On: |
02/06/2018 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Role of dexamethasone in regional pain relief in children undergoing kidney surgery. |
|
Scientific Title of Study
|
Comparison of intravenous and perineural Dexamethasone in Ultra-sound guided Paravertebral Block in Pediatric Patient Undergoing Open Pyeloplasty: A Prospective Double-Blinded Randomized Clinical Study. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
David Vincent |
| Designation |
post graduate resident |
| Affiliation |
Christian Medical College Vellore |
| Address |
Anesthesia department
Christian Medical College Vellore
Vellore
TAMIL NADU
632004
India |
| Phone |
9659473061 |
| Fax |
|
| Email |
hellodavidvincent@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Anita Shirley Joselyn |
| Designation |
professor |
| Affiliation |
Christian Medical College, Vellore |
| Address |
Department of Anesthesia, Christian Medical College, Vellore
Vellore
TAMIL NADU
632004
India |
| Phone |
7358377164 |
| Fax |
|
| Email |
anjeyanth@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Anita Shirley Joselyn |
| Designation |
professor |
| Affiliation |
Christian Medical College, Vellore |
| Address |
Department of Anesthesia, Christian Medical College, Vellore
Cuddalore
TAMIL NADU
632004
India |
| Phone |
7358377164 |
| Fax |
|
| Email |
anjeyanth@gmail.com |
|
|
Source of Monetary or Material Support
|
| Research Office
Carman Block, Bagayam,
Vellore 632002. |
|
|
Primary Sponsor
|
| Name |
FLUID research grant |
| Address |
Christian Medical College
Vellore
623004 |
| Type of Sponsor |
Research institution |
|
|
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 |
| David Vincent |
Christian Medical College , Vellore |
Department of Anaesthesia,
VELLORE
632004
Vellore
TAMIL NADU |
0416-228-2105
0416-2232305
anaesthesia@cmcvellore.ac.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| institutional review board , christian medical college vellore, india |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
healthy ASA 1 OR 2 , |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
preservative free dexamethasone |
preservative free dexamethasone 0.1 mg/kg maximum 4 mg into paravertebral space alone with 0.2% ropivacaine 0.5ml/kg into paravertebral space |
| Comparator Agent |
preservative free dexamethasone |
preservative free dexamethasone 0.1mg/kg maximum 4 mg intravenously alone.
paravertebral block is with plain 0.2% Ropivacaine 0.5ml/kg
|
|
|
Inclusion Criteria
|
| Age From |
2.00 Year(s) |
| Age To |
14.00 Year(s) |
| Gender |
Both |
| Details |
All children between 2 and 14 years posted for open pyeloplasty consented/ assented for study |
|
| ExclusionCriteria |
| Details |
1. Patients with cutaneous infection at the site of needle puncture,
2. Pathology in the paravertebral space,
3. Allergy to local anesthetic drugs,
4. Obesity,
5. Coagulopathy,
6. Creatinine clearance less than 90 ml//min/1.73m2
7. Kyphoscoliosis
8. Diabetes mellitus
9. Malignancy
10. Psychiatric disorder
11. Immunocompromised child (HIV, already on dexamethasone, inflammatory disease)
|
|
|
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 |
| comparing the efficacy and duration of the paravertebral block |
Efficacy of the block will be assessed by calculating total analgesics requirement in both arms in morphine equivalents for 48 hours or till discharge from ward.
Duration of the block will be assessed by calculating the time take from block administration to first rescue analgesia administered in minutes.
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| incidence of adverse events such as vascular puncture (blood aspirate),Abandoned block (unable to place),Failed block (completed but not successful),Respiratory: pneumothorax, respiratory depression, apnea other, Cardiovascular: arrhythmia, hypotension, cardiac arrest, other |
within 48 hours from time of block administration or discharge from ward |
| Incidence and severity scores of pains in recovery and surgical ward.FLACC (Face, Legs, Activity, Cry, Consolability) score for preverbal children and VAS(Visual Analogue Scale) score for verbal children. |
In the recovery ward pain score and rescue analgesia is needed will be noted, at time of arrival and every one hourly till discharge to the surgical ward.
In the surgical ward pain score and rescue analgesia is needed will be noted, at the time of arrival and at least every 4th hourly for first 24 hours and at least every 6th hourly till discharge or till 48 hours.
|
|
|
Target Sample Size
|
Total Sample Size="140"
Sample Size from India="140"
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 3 |
|
Date of First Enrollment (India)
|
01/07/2018 |
| 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="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
none yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
BACKGROUND: Dexamethasone have been shown to potentiate the action of local anesthetic in peripheral nerve block in various study conducted in adult patients. In this proposed study we would like to evaluate the effect of intravenous and perineural preservative-free dexamethasone as an adjuvant on the duration of paravertebral block with ropivacaine in children undergoing open -pyeloplasty. Aim: The aim of this study is to compare the analgesic and adverse effects of dexamethasone as an adjuvant in paravertebral block in children undergoing open pyeloplasty. Objective: Primary Objective: The primary objective of this study will be to evaluate and compare the efficacy and duration of intra-venous verses perineural preservative-free dexamethasone when added to paravertebral block with ropivacaine in post-operative analgesia in children. Secondary Objective: The secondary objective of the study is to evaluate the adverse events and pain score of both intra-venous and paravertebral dexamethasone group |