| CTRI Number |
CTRI/2020/02/023157 [Registered on: 06/02/2020] Trial Registered Prospectively |
| Last Modified On: |
01/08/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Comparison of two methods of pain relief in pediatric laparoscopic surgeries |
|
Scientific Title of Study
|
Randomised double blinded comparative study of the effects of Intravenous lignocaine infusion and Caudal Bupivacaine in pediatric laparoscopic surgeries.
|
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
P GAYATHRI |
| Designation |
FELLOW IN PEDIATRIC ANESTHESIA |
| Affiliation |
RAINBOW CHILDRENS HOSPITAL |
| Address |
AXON ANAESTHESIA 4TH FLOOR OT COMPLEX RAINBOW HOSPITAL ROAD NO 2 BANJARA HILLS
Hyderabad
TELANGANA
500034
India |
| Phone |
9848638850 |
| Fax |
|
| Email |
drgayathrip@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
K SAILAJA |
| Designation |
CONSULTANT |
| Affiliation |
RAINBOW CHILDRENS HOSPITAL |
| Address |
AXON ANAESTHESIA 4TH FLOOR OT COMPLEX RAINBOW HOSPITAL ROAD NO 2 BANJARA HILLS
Hyderabad
TELANGANA
500034
India |
| Phone |
7093322303 |
| Fax |
|
| Email |
sailuk78@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
K SAILAJA |
| Designation |
CONSULTANT |
| Affiliation |
RAINBOW CHILDRENS HOSPITAL |
| Address |
AXON ANAESTHESIA 4TH FLOOR OT COMPLEX RAINBOW HOSPITAL ROAD NO 2 BANJARA HILLS
Hyderabad
TELANGANA
500034
India |
| Phone |
7093322303 |
| Fax |
|
| Email |
sailuk78@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
RAINBOW CHILDRENS HOSPITAL |
| Address |
ROAD NO 2 BANJARA HILLS HYDERABAD TELANGANA 500034 |
| Type of Sponsor |
Other [ACADEMIC STUDY] |
|
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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 |
| P GAYATHRI |
RAINBOW CHILDRENS HOSPITAL |
ROAD NO 2 BANJARA HILLS HYDERABAD TELANGANA
PIN CODE-500034
Hyderabad
TELANGANA |
9848638850
drgayathrip@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTEE RAINBOW HOSPITAL |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
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Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O||Medical and Surgical, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
CAUDAL BUPIVACAINE |
1.2 ML/KG OF BUPIVACAINE GIVEN THROUGH CAUDAL |
| Intervention |
INTRAVENOUS LIGNOCAINE |
1.5 MG/KG OF LIGNOCAINE AS BOLUS OVER 5 MINUTES FOLLOWED BY 1.5 MG/KG/HOUR OF LIGNOCAINE INFUSION INTRAOPERATIVELY |
|
|
Inclusion Criteria
|
| Age From |
6.00 Month(s) |
| Age To |
6.00 Year(s) |
| Gender |
Both |
| Details |
AMERICAN SOCIETY OF ANAESTHESIOLOGISTS GRADE 1 AND 2 CHILDREN
LAPAROSCOPIC ABDOMINAL SURGERIES
WEIGHING 10- 20 KILOGRAMS |
|
| ExclusionCriteria |
| Details |
HISTORY OF ALLERGY TO LOCAL ANAESTHETICS
HISTORY OF SEIZURES
HISTORY OF CARDIAC DISEASES |
|
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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, Investigator and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Total fentanyl requirement intraoperatively and postoperatively and time to first rescue analgesia from the time of extubation
|
T Extubation-at extubation total fentanyl used
T postoperative 2 hours- total fentanyl used postoperatively in 2 hours
T rescue- Time from extubation to first rescue analgesia
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Heart rate, Systolic blood pressure and Diastolic blood pressure |
T0 (baseline), T1 (at the time of port insertion), Tpeak (maximum reading during the procedure), T2 (at extubation), T3(postoperative- 0 min), T4(postoperative- 5 min), T5(postoperative-15 min), T6(postoperative- 30 min), T7( postoperative- 1 hour), T8(postoperative- 2 hour) |
| Pediatric anaesthesia Emergence delirium score and Face,Legs,Activity,Cry Consolability FLACC pain scale |
At awakening,At postoperative 30 minutes, 1 hour and 2 hour |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
Final Enrollment numbers achieved (Total)= "100"
Final Enrollment numbers achieved (India)="100" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
12/02/2020 |
| Date of Study Completion (India) |
30/09/2021 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
The study aims to compare the efficacy of intravenous lignocaine given as 1.5 mg/kg bolus over 5 minutes followed by 1.5 mg/kg/hour infusion, with caudal bupivacaine 2.5 mg/kg prepared to 1.2 ml/kg, in 100 pediatric patients in the age group of 6 months to 6 years, undergoing laparoscopic abdominal surgeries with 50 patients in each group allocated randomly. The total intravenous fentanyl requirement both intraoperatively and postoperatively, time to first rescue analgesia after extubation, heart rate, systolic and diastolic blood pressure at various time points, pediatric anaesthesia emergence delirium score and FLACC Pain score in the postoperative period will be noted to compare the effects. |