| CTRI Number |
CTRI/2021/10/037040 [Registered on: 01/10/2021] Trial Registered Prospectively |
| Last Modified On: |
30/09/2021 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
To compare effects of ropivacaine alone and ropivacaine along with nalbuphine and magnesium sulphate in pain control among children in regional anaesthesia(caudal block) |
|
Scientific Title of Study
|
A comparative evaluation of analgesic efficacy of nalbuphine and magnesium sulphate as an adjuvant to ropivacaine in paediatric caudal block |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Sonam |
| Designation |
Junior Resident Department of Anaesthesiology |
| Affiliation |
Guru Gobind Singh Medical College and Hospital. |
| Address |
Department of Anaesthesiology,
Guru Gobind Singh Medical
College And Hospital,Faridkot.
Faridkot
PUNJAB
151203
India |
| Phone |
9817269366 |
| Fax |
|
| Email |
sbugra94@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DrAmanjot Singh |
| Designation |
Associate Professor,Department of Anaesthesiology |
| Affiliation |
Guru Gobind Singh Medical College and Hospital. |
| Address |
Department of Anaesthesiology,
Guru Gobind Singh Medical
College And Hospital,Faridkot
Faridkot
PUNJAB
151203
India |
| Phone |
9814921142 |
| Fax |
|
| Email |
amanjotrajpal@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DrAmanjot Singh |
| Designation |
Associate Professor,Department of Anaesthesiology |
| Affiliation |
Guru Gobind Singh Medical College and Hospital. |
| Address |
Department of Anaesthesiology,
Guru Gobind Singh Medical
College And Hospital,Faridkot
Faridkot
PUNJAB
151203
India |
| Phone |
9814921142 |
| Fax |
|
| Email |
amanjotrajpal@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Anaesthesiology, Guru Gobind Singh Medical College And Hospital,Faridkot. |
|
|
Primary Sponsor
|
| Name |
Department of Anaesthesiology |
| Address |
Department Of Anaesthesiology,
Guru Gobind Singh Medical
College And Hospital ,Faridkot |
| Type of Sponsor |
Government medical college |
|
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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 |
| Sonam |
GGSMCH |
Department of anaesthesiology
Faridkot
PUNJAB |
9872069366
sbugra94@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Ethics Committee of GGS Medical College and Hospital Faridkot |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: U07-U07||Provisional assignment of new diseases of uncertain etiology or emergency use, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Magnesium Sulphate as adjuvant to Ropivacaine. |
Patients will receive 1ml/kg of 0.2% Ropivacaine with 50 mg Magnesium sulphate in 1ml normal saline in paediatric caudal block. |
| Comparator Agent |
Nalbuphine as adjuvant to Ropivacaine. |
Patient will receive 1ml/kg of
0.2% Ropivacaine with 0.1 mg/kg
Nalbuphine in 1ml normal saline in paediatric caudal block. |
| Intervention |
Ropivacaine |
Patients will receive 1ml/kg of 0.2% Ropivacaine with 1ml normal saline in paediatric caudal block. |
|
|
Inclusion Criteria
|
| Age From |
1.00 Year(s) |
| Age To |
10.00 Year(s) |
| Gender |
Both |
| Details |
Paediatric participants aged between 1-10 years.
American Society of Anaesthesiologists grade I and
II patients.
Patients undergoing infraumbilical surgeries. |
|
| ExclusionCriteria |
| Details |
History of developmental delay or mental retardation, which could make observational pain intensity assessment difficult.
Children with known allergy to any of the study drugs.
Children with coagulation disorders.
Childrenwith coexisting medical illness.
Pre-existing neurological diseases.
Anatomical abnormalities of spine and sacrum.
Any signs of infection at the site of the proposed caudal block. |
|
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Method of Generating Random Sequence
|
Computer generated randomization |
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Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
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Primary Outcome
|
| Outcome |
TimePoints |
To evaluate analgesic efficacy of ropivacaine alone in paediatric caudal block
To evaluate analgesic efficacy of ropivacaine with nalbuphine in paediatric caudal block
To evaluate analgesic efficacy of ropivacaine with magnesium sulphate in paediatric caudal block
To compare analgesic efficacy of ropivacaine alone ,with nalbuphine and with magnesium sulphate in paediatric caudal block
|
Duration of analgesia will be assessed.
Pain intensity will be assessed at end of operation every 2hrly ,4hrly and 8hrly using FLACC Pain scale.
|
|
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Secondary Outcome
|
| Outcome |
TimePoints |
Monitoring of hemodynamic parameters ( HR,Oxygen saturation ,Temperature) intraoperatively and postoperatively.
Perioperative adverse effects will be recorded.
|
Vitals monitoring will be done before induction and every 5 min for half an hour and every 10 min until the end of surgery
Postoperative hemodynamic monitoring for 24hrs will be done
|
|
|
Target Sample Size
|
Total Sample Size="90"
Sample Size from India="90"
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)
|
10/10/2021 |
| 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 Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
NA |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
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Brief Summary
|
INTRODUCTION: Caudal epidural blockade in children is one of the most widely administered techniques of regional anaesthesia. Ropivacaine is a long acting amide local anaesthetic, acts via reversible inhibition of sodium ions influx in nerve fibers and produce effects similar to other local anaesthetics. Adding Nalbuphine to epidural analgesic agents, provides an increase in the efficacy and the duration of postoperative analgesia. Combined epidural magnesium sulfate administration significantly reduces postoperative analgesic requirements. Aims and Objectives – To evaluate analgesic efficacy of nalbuphine and magnesium sulphate as an adjuvant to ropivacaine in paediatric caudal block. Materials and Methods- The study will be conducted in department of Anaesthesiology, GGSMCH, Faridkot. Inclusion Criteria – Age group 1-10yrs, ASA (American Society of Anaesthesiologists) grade I &II. Patients will be divided in 3 study groups of 30 patients each. Group A: Will receive 1ml/kg of 0.2% Ropivacaine and 1ml normal saline. Group B: Will receive 1ml/kg of 0.2% Ropivacaine with 0.1 mg/kg Nalbuphine in 1ml normal saline. Group C: Will receive 1ml/kg of 0.2% Ropivacaine with 50 mg Magnesium sulphate in 1ml normal saline.
Surgery will be done under general anaesthesia . Duration of postoperative analgesia and total analgesia postoperatively in first 24hrs will be noted and compared. After completion of study, observations obtained will be tabulated and analysed using appropriate statistical methods. P value < 0.05 will be taken as significant and < 0.001 will be taken as highly significant.
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