| CTRI Number |
CTRI/2023/01/049179 [Registered on: 24/01/2023] Trial Registered Prospectively |
| Last Modified On: |
10/01/2023 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
The study aims to compare between types of anaesthesia-caudal block(type of anaesthesia given to spine), dorsal penile nerve block(block that numbs nerve that supplies sensations to penis), topical lignocaine ointment/cream(topical anaesthesia) to reduce pain in children undergoing sugeries on penis |
|
Scientific Title of Study
|
Comparative study of caudal block, dorsal penile nerve block and topical lignocaine ointment for paediatric penile surgeries |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Siddharth Rampally |
| Designation |
Senior Resident |
| Affiliation |
ESIC Medical College and Hospital |
| Address |
Department of Anaesthesia, Operation theatre, First floor, Super speciality hospital block ESIC Medical College, Sanathnagar, Hyderabad, Telangana
Hyderabad
TELANGANA
500038
India |
| Phone |
8019814944 |
| Fax |
|
| Email |
sidhu_rampal@yahoo.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Prerna Bhola |
| Designation |
Assistant Professor |
| Affiliation |
ESIC Medical College and Hospital |
| Address |
Department of Anaesthesia, Operation theatre, First floor, Super speciality hospital block ESIC Medical College, Sanathnagar, Hyderabad, Telangana
Hyderabad
TELANGANA
500038
India |
| Phone |
9440152961 |
| Fax |
|
| Email |
dr.prernabhola@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Prerna Bhola |
| Designation |
Assistant Professor |
| Affiliation |
ESIC Medical College and Hospital |
| Address |
Department of Anaesthesia, Operation theatre, First floor, Super speciality hospital block ESIC Medical College, Sanathnagar, Hyderabad, Telangana
Mahbubnagar
TELANGANA
500038
India |
| Phone |
9440152961 |
| Fax |
|
| Email |
dr.prernabhola@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Anaesthesiology, ESIC Medical College and Hospital, Sanathnagar, Hyderabad-500038 |
|
|
Primary Sponsor
|
| Name |
ESIC Medical College |
| Address |
Department of Anaesthesiology, ESIC Medical College and Hospital, Sanathnagar, Hyderabad-500038 |
| Type of Sponsor |
Government medical college |
|
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Details of Secondary Sponsor
|
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Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| R Siddharth |
ESIC Medical college and Hospital |
Department of Anaesthesia, Operation theatre, 1st floor, ESI Superspeciality hospital
Hyderabad
TELANGANA |
8019814944
sidhu_rampal@yahoo.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee |
Approved |
|
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Regulatory Clearance Status from DCGI
|
|
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Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: N471||Phimosis, (2) ICD-10 Condition: N470||Adherent prepuce, newborn, (3) ICD-10 Condition: N475||Adhesions of prepuce and glans penis, |
|
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Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Caudal block |
In caudal block group, Inj. Bupivacaine 0.25% is given at the dose of 0.5ml/kg in the caudal space prior to surgery
The postoperative pain scale in the first 12 hours after surgery will be noted and the time interval for the first rescue analgesia would also be recorded
|
| Intervention |
Dorsal penile nerve block |
In dorsal penile nerve block group, Inj. Bupivacaine 0.25% is given at the dose of 0.2ml/kg at the base of penis prior to surgery
The postoperative pain scale in the first 12 hours after surgery will be noted and the time interval for the first rescue analgesia would also be recorded |
| Intervention |
Topical lignocaine ointment/cream |
Lignocaine 5% ointment/cream will be applied in the other group to the foreskin and mucosal surface of the penis prior to surgery
The postoperative pain scale in the first 12 hours after surgery will be noted and the time interval for the first rescue analgesia would also be recorded |
|
|
Inclusion Criteria
|
| Age From |
1.00 Month(s) |
| Age To |
12.00 Year(s) |
| Gender |
Both |
| Details |
ASA 1 and 2 patients aged 1 month to 12 years of either sex undergoing elective surgery under general anaesthesia |
|
| ExclusionCriteria |
| Details |
Children with-
1)Coagulation disorders
2)Allergy history to local anaesthetics
3)Infection in lower back and around perineal region
4)Spinal deformities |
|
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Method of Generating Random Sequence
|
Random Number Table |
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Method of Concealment
|
Not Applicable |
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Blinding/Masking
|
Participant, Investigator and Outcome Assessor Blinded |
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Primary Outcome
|
| Outcome |
TimePoints |
| Heart rate, Mean Arterial Pressure(MAP) will be measured |
Heart rate, Mean arterial pressure will be recorded at baseline, from incision at 0min, 5min, 10min, 15min and every 15 min thereafter till the end of surgery |
|
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Secondary Outcome
|
| Outcome |
TimePoints |
| the postoperative pain scale(FLACC score) and the time needed for first rescue analgesia |
postoperative pain scale(FLACC score) is recorded in the first 12 hours hourly after surgery and time of first rescue analgesia would be noted |
|
|
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
|
N/A |
|
Date of First Enrollment (India)
|
01/02/2023 |
| 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)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
None yet |
|
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
|
Procedures like circumcision and adhesiolysis are commonly performed surgeries in pediatric population, which cause significant pain during the surgery and after the surgery. In this study we intend to compare the analgesic effects between Caudal block, Dorsal penile nerve block & Lignocaine cream/ointment application from intraoperative period to the requirement of first rescue analgesia postoperatively as a multimodal analgesic strategy
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