| CTRI Number |
CTRI/2024/09/074237 [Registered on: 24/09/2024] Trial Registered Prospectively |
| Last Modified On: |
25/09/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparing two team approaches to speed up anesthesia preperations in infant bone surgery: Doctor and Technician vs. Two doctors. |
|
Scientific Title of Study
|
Comparison of ‘Two models’ Anaesthesiologist-Technician verses Anaesthesiologist-
Junior Anaesthesiologist models to evaluate ‘anaesthetic ready time’ in orthopaedic
infant surgery. A Randomized Controlled Trial. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Sandeep Diwan |
| Designation |
Senior Consultant |
| Affiliation |
Sancheti Institute of Orthopedics and Rehabiliation |
| Address |
operation theatre complex, Second floor, Department of AnesthesiologSancheti Institute of Orthopedics and Rehabiliation , 16, Shivajinagar, Pune- 411005
Pune
MAHARASHTRA
411005
India |
| Phone |
8484914584 |
| Fax |
|
| Email |
sdiwan1965@gmx.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sandeep Diwan |
| Designation |
Senior Consultant |
| Affiliation |
Sancheti Institute of Orthopedics and Rehabiliation |
| Address |
operation theatre complex, Second floor, Department of AnesthesiologSancheti Institute of Orthopedics and Rehabiliation , 16, Shivajinagar, Pune- 411005
Pune
MAHARASHTRA
411005
India |
| Phone |
8484914584 |
| Fax |
|
| Email |
sdiwan1965@gmx.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sandeep Diwan |
| Designation |
Senior Consultant |
| Affiliation |
Sancheti Institute of Orthopedics and Rehabiliation |
| Address |
operation theatre complex, Second floor, Department of AnesthesiologSancheti Institute of Orthopedics and Rehabiliation , 16, Shivajinagar, Pune- 411005
Pune
MAHARASHTRA
411005
India |
| Phone |
8484914584 |
| Fax |
|
| Email |
sdiwan1965@gmx.com |
|
|
Source of Monetary or Material Support
|
| Sancheti Institute of Orthopedics and Rehabilitation 11/12 Thube Park, 16, Shivajinagar, Pune – 411005 Maharashtra,India |
|
|
Primary Sponsor
|
| Name |
Sancheti Institute of Orthopedics and Rehabilitation |
| Address |
11/12 Thube Park, 16, Shivajinagar, Pune – 411005 Maharashtra,India |
| Type of Sponsor |
Research institution and hospital |
|
|
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 Sandeep Diwan |
Sancheti Institute of Orthopedics and Rehabilitation |
Department of Anesthesiology,Operation theater, Second floor,Sancheti Institute of Orthopedics and Rehabilitation,16 Shivajinagar, Pune 411005
Pune
MAHARASHTRA |
8484914584
sdiwan1965@gmx.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, Sancheti Hospital of Orthopedics and Rehabilitation |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O||Medical and Surgical, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Group A- Caudal block Anaesthesiologist-Technician model |
Anaesthesiologist-Technician model for Caudal block with 0.2% Ropivacaine (1ml/kg body weight) + clonidine (1mcg/kg body weight) given once before procedure |
| Comparator Agent |
Group B- Supra-inguinal fascia iliaca block Anaesthesiologist-Technician model |
Anaesthesiologist-Technician model for Supra-inguinal fascia iliaca blockin OT for 0.2 Ropivacaine (1ml/kg body weight) +clonidine (1mcg/kg body weight) will be given once before procedure |
| Comparator Agent |
GROUP C Caudal block Anaesthesiologist-Junior Anaesthesiologist model |
Anaesthesiologist-Junior Anaesthesiologist model for Caudal block with 0.2% Ropivacaine (1ml/kg body weight) + clonidine (1mcg/kg body weight) will be given once before procedure |
| Comparator Agent |
Group D Supra-inguinal fascia iliaca block Anaesthesiologist-Junior Anaesthesiologist model |
Anaesthesiologist-Junior Anaesthesiologist model for suprainguinal block using 0.2 Ropivacaine (1ml/kg body weight) +clonidine (1mcg/kg body weight) will be given once before procedure |
|
|
Inclusion Criteria
|
| Age From |
1.00 Year(s) |
| Age To |
12.00 Year(s) |
| Gender |
Both |
| Details |
ASA physical status grade I and II paediatric patients undergoing infra
umbilical surgeries under General anaesthesia. |
|
| ExclusionCriteria |
| Details |
1. Parenal or guardian refusal 2. Allergy or hypersensitivity to any drugs 3. Known hypersensitivity to dexmedetomidine 4. Pre-existing cardiovascular, respiratory, cerebrovascular, neurological disease or coagulation disorders 5. Local Infection at caudal punvture site. |
|
|
Method of Generating Random Sequence
|
Adaptive randomization, such as minimization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| total time required to perform a combined general and regional anesthesia. |
time will be recorded one time immediately after GA and regional block is given |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
The time of the start for aseptic prep of the skin
Surgeon satisfaction.
Procedure-related complications.
|
time will be recorded once when intervention is complete. procedure related complications will be recorded after the surgery is over in first 24 hours |
|
|
Target Sample Size
|
Total Sample Size="130"
Sample Size from India="130"
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)
|
04/10/2024 |
| 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="1"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
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
|
Paediatric regional anaesthesia (RA) today is one
of the fastest growing and exciting aspects of paediatric anaesthesia, which
requires an ongoing fervour to learn. Application of paediatric regional
anaesthesia in neonates, infants, toddlers and children is undertaken to treat
perioperative pain without disturbing the physiological milieu. It provides
excellent pain relief and allows caregivers to use multimodal analgesic
techniques and decrease the use of opioids. Considerable progress has been made
in the practice of PRA over the past few years including the availability of
information on safety and the incorporation of ultrasound guidance. The primary aim of
the study was to determine whether the two-attending anaesthesiologist model
decreases the amount of operating room time required for a combined general
anaesthesia and ultrasound-guided regional nerve block for lower limb surgery [caudal
block and or supra-inguinal fascia iliaca block] in children requiring a
simultaneous general anaesthetic as compared to a single anaesthesiologist
model.
|