| CTRI Number |
CTRI/2019/08/020998 [Registered on: 30/08/2019] Trial Registered Prospectively |
| Last Modified On: |
25/08/2022 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparison of two different blocks and pain relief provided by them in children. |
|
Scientific Title of Study
|
Comparison of single injection of erector spinae plane block and paravertebral block in reducing post operative pain in children: a prospective, double blinded, randomized controlled trial |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Arlin Baby Thomas |
| Designation |
PG Registrar in Anaesthesiology |
| Affiliation |
Christian Medical College, Vellore |
| Address |
Department of Anaesthesiology, Christian Medical College and Hospital, Vellore
Vellore TAMIL NADU 632004 India |
| Phone |
8628030418 |
| Fax |
|
| Email |
arlinthomas@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Ekta Rai |
| Designation |
Professor in Anaesthesiology |
| Affiliation |
Christian Medical College, Vellore |
| Address |
Department of Anaesthesiology, Christian Medical College and Hospital, Vellore
Vellore TAMIL NADU 632004 India |
| Phone |
9789250113 |
| Fax |
|
| Email |
drektarai@yahoo.com |
|
Details of Contact Person Public Query
|
| Name |
Dr Ekta Rai |
| Designation |
Professor in Anaesthesiology |
| Affiliation |
Christian Medical College, Vellore |
| Address |
Department of Anaesthesiology, Christian Medical College and Hospital, Vellore
Vellore TAMIL NADU 632004 India |
| Phone |
9789250113 |
| Fax |
|
| Email |
drektarai@yahoo.com |
|
|
Source of Monetary or Material Support
|
| Seed Research Grant, Research committee, Christian Medical College, Vellore - 632004 |
|
|
Primary Sponsor
|
| Name |
Fluid Research Grant |
| Address |
Christian Medical College, Vellore |
| Type of Sponsor |
Research institution and hospital |
|
|
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 |
| Arlin Baby Thomas |
christian medical college |
department of anaesthesiology, paediatric division Vellore TAMIL NADU |
8628030418
arlinthomas@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| ETHICS COMMITTEE CMC VELLORE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: Q623||Other obstructive defects of renalpelvis and ureter, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Intervention agent 1
|
Erector spinae plane block |
| Comparator Agent |
Intervention agent 2 |
Paravertebral Block |
|
|
Inclusion Criteria
|
| Age From |
1.00 Year(s) |
| Age To |
15.00 Year(s) |
| Gender |
Both |
| Details |
1. ASA I, II
2. children of age group 1-15 years
3. patients undergoing pyeloplasty or simple nephrectomy |
|
| ExclusionCriteria |
| Details |
1. Infection at the site of injection
2. Coagulopathy
3. Abnormal anatomy
4. Allergy to local anesthetics |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To compare the difference in the pain in children aged 1 to 15 years undergoing open pyeloplasty or simple nephrectomy, after receiving single injection of either erector spinae plane block or paravertebral block intra operatively. |
upto 48 hours postoperatively |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To compare the time to first post operative rescue analgesia and the total dose of post operative analgesics needed in the first 48 hours after operation in both groups. |
upto 48 hours postoperatively |
| To compare the time needed to perform the blocks under ultrasound. |
intraoperatively |
| To compare the effect of the blocks on hemodynamic changes from baseline, during skin incision, at 15 minutes interval intraoperatively till the procedure is over. |
intraoperatively |
|
|
Target Sample Size
|
Total Sample Size="100" Sample Size from India="100"
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)
|
02/09/2019 |
| 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="0" Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
nil |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
BACKGROUND: Post
operative pain is an inevitable consequence of surgery even in children. The
length of the incision causes significant post operative pain in children after
pyeloplasty and simple nephrectomy. Both erector spinae plane block and paravertebral
block have been proven to be effective in providing post operative analgesia.
However no comparison studies have been done on their analgesic efficacy.
AIM: We aim
to compare the effects of single injection of erector spinae plane block and paravertebral
block on post operative pain and analgesic requirements in children after open
pyeloplasty and simple nephrectomy.
STUDY DESIGN: double
blinded, prospective, randomised controlled trial
MATERIAL AND METHODS: a total
of 100 American society of
Anesthesiologists physical status 1 and 2
paediatric patients, aged 1-15 years,
scheduled to undergo open pyeloplasty or simple nephrectomy will be
randomly allocated to receive either erector spinae plane block (Group A: n =
50) or paravertebral block (Group B: n=50) with 0.2% ropivacaine 0.8ml/kg and
0.5ml/kg respectively pre operatively post induction of general anesthesia. A
standard protocol will be used to provide general anesthesia. Post operatively
FLACC (faces, legs, activity, cry, consolability) score or VAS (visual analog
score) will be used for pain assessment according to age of the patient at 0,
1, 2, 6, 12, 18, 24, 36, 48 hours and one week later on follow up. The time to
first rescue analgesia, total analgesic requirement, time taken to perform the
blocks, intraoperative hemodynamic changes and post operative parental and
surgeon satisfactions will be assessed. Data collected will be entered in
Epidata software and analysed. |