| CTRI Number |
CTRI/2025/05/087475 [Registered on: 23/05/2025] Trial Registered Prospectively |
| Last Modified On: |
22/05/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Pain relief in laparoscopic urological surgery after local anaesthetic in the space adjacent to the spine in children |
|
Scientific Title of Study
|
Comparison of analgesic efficacy of a single shot ultrasound guided retrolaminar block versus standard care in paediatric patients undergoing Laparoscopic urological surgery– a Randomized Controlled Study |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Lakshmi Kumar |
| Designation |
Professor and Head |
| Affiliation |
Amrita Institute of Medical Sciences |
| Address |
Department of Anaesthesia and Critical care
Tower 6 Floor 1
AIMS
Kochi
Ernakulam
KERALA
682041
India |
| Phone |
9496211333 |
| Fax |
914842852020 |
| Email |
lakshmi.k.238@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Lakshmi Kumar |
| Designation |
Professor and Head |
| Affiliation |
Amrita Institute of Medical Sciences |
| Address |
Department of Anaesthesia and Critical care
Tower 6 Floor 1
AIMS
Kochi
Ernakulam
KERALA
682041
India |
| Phone |
9496211333 |
| Fax |
914842852020 |
| Email |
lakshmi.k.238@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Anagha P Vinay |
| Designation |
Fellow Pediatric Anaesthesia |
| Affiliation |
Amrita Institute of Medical Sciences |
| Address |
Department of Anaesthesia and Critical care
Tower 6 Floor 1
AIMS
Kochi
Ernakulam
KERALA
682041
India |
| Phone |
7907990488 |
| Fax |
914842852020 |
| Email |
anaghapvinay.123@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Anaesthesia
Amrita Institute of Medical sciences
Kochi 682041 |
|
|
Primary Sponsor
|
| Name |
Amrita Institute Of Medical Sciences |
| Address |
Department of Anaesthesia and Critical care
Tower 6 Floor 1
AIMS
Kochi 682041 |
| Type of Sponsor |
Private 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 |
| Dr Lakshmi Kumar |
Amrita Institute Of Medical Sciences |
Department of Anaesthesia and Critical care
Tower 6 Floor 1
AIMS Kochi
Ernakulam
KERALA |
9496211333
914842852020
lakshmi.k.238@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| AIMS Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: N29||Other disorders of kidney and ureter in diseases classified elsewhere, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Standard care with local infiltration at the port sites |
0.2 % ropivacaine will be injected at port sites before insertion of the scope and at the end of surgery. The volume will not exceed 1ml/kg body weight. |
| Intervention |
Ultrasound guided retrolaminar block at T10 level after induction of anaesthesia |
Under anaesthesia with ultrasound guidance, 0.5 ml / kg of 0.2 % ropivacaine injected in the retrolaminar space on one side at T 10 level or bilaterally as required for the surgery |
|
|
Inclusion Criteria
|
| Age From |
1.00 Year(s) |
| Age To |
10.00 Year(s) |
| Gender |
Both |
| Details |
ASA I and II pediatric patients for laparoscopic urological surgery |
|
| ExclusionCriteria |
| Details |
1. Infection or anatomical abnormality around
site of block
2. Coagulation disorder or sepsis.
3. Hypersensitivity or contra-indication to any
of the study drugs- local anesthetic or
analgesic
4. Technical difficulty in performing the block |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| The requirement for post-operative analgesia in the first 24 h after surgery |
24 h after surgery |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Intraoperative opioid consumption
2. HR and BP at defined time points during surgery.
3. Pain measured by Children Hospital of Eastern Ontario Pain Scale post-operatively.
|
Baseline T0
2. At port insertion Tp
3. 90 minutes into surgery T90
4. End of surgery Te
5. Shifting Ts
6. In the ICU Ticu0
ICU at 6 12 18 and 24 h |
|
|
Target Sample Size
|
Total Sample Size="50"
Sample Size from India="50"
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 1 |
|
Date of First Enrollment (India)
|
01/07/2025 |
| 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="0"
Months="9"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Retrolaminar block is a novel analgesic technique for pain relief. We sought to evalauate if the pain releief with this was superior to the analgesia proviided by local infiltration |