| CTRI Number |
CTRI/2024/06/069257 [Registered on: 20/06/2024] Trial Registered Prospectively |
| Last Modified On: |
19/06/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
A clinical trial for assessment of Dexmedetomidine as an adjuvant to ropivacaine in ultrasound-guided Erector spinae plane block in paediatric abdominal surgeries. |
|
Scientific Title of Study
|
A randomized controlled trial to assess the efficacy of dexmedetomidine as an adjuvant to ropivacaine in ultrasound guided erector spinae plane block in paediatric abdominal surgeries. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Pooja Kumari Singh |
| Designation |
Junior Resident |
| Affiliation |
Aligarh Muslim University |
| Address |
Department of Anaesthesiology and Critical Care, Jawaharlal Nehru Medical College, AMU, Aligarh
Uttar Pradesh
202002
India
Department of Anaesthesiology and Critical Care, Jawaharlal Nehru Medical College, AMU, Aligarh
Uttar Pradesh
202002
India
Aligarh
UTTAR PRADESH
202002
India |
| Phone |
8789311383 |
| Fax |
|
| Email |
pooja.ngr25@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Farah Nasreen |
| Designation |
Assistant Professor |
| Affiliation |
Aligarh Muslim University |
| Address |
Department of Anaesthesiology and Critical Care, Jawaharlal Nehru Medical College, AMU, Aligarh
Uttar Pradesh
202002
India
Department of Anaesthesiology and Critical Care, Jawaharlal Nehru MedicalCollege, AMU, Aligarh
Uttar Pradesh
202002
India
Aligarh
UTTAR PRADESH
202002
India |
| Phone |
9897067670 |
| Fax |
|
| Email |
kazmifarah@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Pooja Kumari Singh |
| Designation |
Junior resident |
| Affiliation |
Aligarh Muslim University |
| Address |
Department of Anaesthesiology and Critical Care, Jawaharlal Nehru Medical College, AMU, Aligarh
Uttar Pradesh
202002
India
Department of Anaesthesiology and Critical Care, Jawaharlal Nehru Medical College, AMU, Aligarh
Uttar Pradesh
202002
India
Aligarh
UTTAR PRADESH
202002
India |
| Phone |
8789311383 |
| Fax |
|
| Email |
pooja.ngr25@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Anaesthesiology and Critical Care,Jawaharlal Nehru Medical College AMU Aligarh |
|
|
Primary Sponsor
|
| Name |
Department of Anaesthesiology and Critical Care Jawaharlal Nehru Medical College AMU Aligarh |
| Address |
Department of Anaesthesiology and Critical Care,Jawaharlal Nehru Medical College, AMU Aligarh |
| 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 |
| Pooja Kumari Singh |
Jawaharlal Nehru Medical College AMU Aligarh |
Department of Anaesthesiology and Critical Care,Jawaharlal Nehru Medical College AMU Aligarh
Aligarh
UTTAR PRADESH |
8789311383
pooja.ngr25@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee |
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, (2) ICD-10 Condition: K928||Other specified diseases of the digestive system, (3) ICD-10 Condition: K929||Disease of digestive system, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Ultrasound guided Erector Spinae plane block using Dexmedetomidine as an adjuvant to Ropivacaine |
0.2% Ropivacaine + Dexmedetomidine 0.5 mcg/kg (1ml) to a total volume of o.5 ml / kg on each side |
| Comparator Agent |
Ultrasound-guided Erector spinae plane block with ropivacaine and NaCl in Paediatric abdominal surgeries. |
0.2% Ropivacaine + 1 ml of 0.9% NaCl to a total volume of 0.5 ml/kg on each side |
|
|
Inclusion Criteria
|
| Age From |
2.00 Year(s) |
| Age To |
10.00 Year(s) |
| Gender |
Both |
| Details |
Consent of patient(>9yrs,parents/guardian
ASA grade 1& 2
Weight between 10 kg to 30 kg
Patients undergoing elective abdominal surgery under general anaesthesia |
|
| ExclusionCriteria |
| Details |
No consent
Allergy history
Skin infection
Deranged blood clotting
Congenital abnormalities
Systemic diseases
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Time to first rescue analgesic. |
24 hrs |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1.Intraoperative & postoperative opioid requirement
2.Postoperative pain score using CHEOPS scale
3.intraoperative hemodynamic parameters
4.Effect on emergence delirium
5.Complications if any |
1o min, 30 min, 60 min postoperatively & hourly upto 4 hrs & 6 hourly upto 24 hrs postoperatively |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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)
|
30/06/2024 |
| 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="2"
Months="0"
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
|
Adequate postoperative pain assessment in pediatric patients may significantly improve their comfort and quality of life. ESP block is an emergency regional anaesthetic technique with significant potential and clinical benefit. ESP block provides visceral as well as somatic analgesia, relieves acute as well as chronic pain and can be utilized for analgesia at cervical, thoracic and abdominal levels with minimal side effects. ESPB have opioid sparing effect in pediatric patients, even in major surgeries. Dexmedetomidine has been shown to increase the duration of postop analgesia when used as an adjuvant in various nerve blocks in pediatric patients. In addition, dexmedetomidine provides a stable hemodynamic parameters and reduces the incidence of emergence delirium in pediatric patients. Available literature highlights the utility of Dexmedetomidine in terms of better analgesia and hemodynamic parameters when used as an adjuvant with ESPB in adults. The present study is designed to evaluate the efficacy of Dexmedetomidine as an adjuvant to Ropivacaine in bilateral ESP block in pediatric abdominal surgeries. |