| CTRI Number |
CTRI/2024/09/073645 [Registered on: 09/09/2024] Trial Registered Prospectively |
| Last Modified On: |
03/09/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparison of neural blockade type of Anaesthesia intervention in two group of patients |
|
Scientific Title of Study
|
Ultrasound-Guided crosswise approach of Popliteal sciatic Block Through a Common Paraneural Sheath Versus separate Injections at Tibial and Common peroneal nerve sheaths on Diabetic foot surgery patients: A Prospective, Randomized, Double blind Study |
| 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.Azhahiriraja K |
| Designation |
Post graduate |
| Affiliation |
Ganga medical centre and Hospital |
| Address |
Ganga Medical Centre
313 , Mettuppalayam road ,
Saibaba colony , Coimbatore
641038
Coimbatore TAMIL NADU 641038 India |
| Phone |
8883338830 |
| Fax |
|
| Email |
azhahiriraja@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr.G.Venkateswaran |
| Designation |
Senior consultant |
| Affiliation |
Ganga medical centre and hospitals |
| Address |
Ganga Medical Centre
313 , mettuppalam road , saibaba colony , Coimbatore
641038
Coimbatore TAMIL NADU 641043 India |
| Phone |
9486661892 |
| Fax |
|
| Email |
venkatbharathi2005@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Dr.G.Venkateswaran |
| Designation |
Senior consultant |
| Affiliation |
Ganga medical centre and hospitals |
| Address |
Department of Anaesthesiology
Ganga Medical Centre
313 , Mettuppalayam Road , Saibabacolony ,Coimbatore
Coimbatore TAMIL NADU 641043 India |
| Phone |
9486661892 |
| Fax |
|
| Email |
venkatbharathi2005@gmail.com |
|
|
Source of Monetary or Material Support
|
| Ganga medical centre and hospitals
313 , Mettuppalayam road
saibaba colony ,
coimbatore - 641038 |
|
|
Primary Sponsor
|
| Name |
Ganga medical centre and hospitals |
| Address |
313 Mettupalayam road
Saibaba colony
Coimbatore - 641038 |
| Type of Sponsor |
Private hospital/clinic |
|
|
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 Venkateswaran |
Ganga medical centre and hospitals |
4th Floor
OT Complex
Department of Anaesthesia Coimbatore TAMIL NADU |
9486661892
venkatbharathi2005@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Review Board Department Of Anaesthesia Ganga medical centre and Hospital Private Limited |
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 |
| Comparator Agent |
CAPS |
ultra sound guided popliteal sciatic block - seperate injection through tibial and common peroneal nerve sheaths |
| Intervention |
Crosswise approach of popliteal sciatic block |
Ultrasound guided crosswise approach of popliteal sciatic block through common paraneural sheath |
|
|
Inclusion Criteria
|
| Age From |
45.00 Year(s) |
| Age To |
75.00 Year(s) |
| Gender |
Both |
| Details |
•Diabetic Patients coming with non healing ulcer over foot and ankle
•Patients of ASA physical status I, II & III.
•Patients who are oriented to give consent.
|
|
| ExclusionCriteria |
| Details |
•Patient refusal
•Patients of ASA physical status IV
•Known hypersensitivity to local anaesthetic drugs.
•Patients who are not oriented to give consent.
•Head injury and alcohol abuse patients.
•Patients with bleeding diathesis
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Double Blind Double Dummy |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Sensory and Motor Onset of Nerve block |
30 Minutes |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| heart rate,blood pressure,map,saturation changes |
5 , 10 ,15 ,20 minutes |
|
|
Target Sample Size
|
Total Sample Size="80" Sample Size from India="80"
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)
|
16/09/2024 |
| 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)
|
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
|
The blockade of the sciatic nerve in the popliteal fossa is a common technique used to provide regional anaesthesia and analgesia for surgeries involving the foot and ankle. With the advent of ultrasound for performing nerve blocks, it has greatly reduced the chances of block failure. There is reduction in the volume of local anaesthetic with real time visualization of the drug spread. Positioning the patient may not be always possible. The aim of the present study was to evaluate the hypothesis that crosswise approach of popliteal sciatic nerve blockade through common paraneural sheath results shorter onset time when compared with post bifurcation injection external to the paraneural tissue MATERIALS AND METHODS: After obtaining the institutional ethical committee approval, 80 ASA I II and III patients who met the inclusion criteria were selected and randomly divided into 2 groups of 40 each. GROUP A patients received single injection of ultrasound- guided crosswise approach of popliteal sciatic block at the site of bifurcation through a common peroneal sheath GROUP B patients received ultrasound- guided crosswise approach of popliteal sciatic blockade 2 separate circumferential injections of the tibial and common peroneal nerves distally to sciatic nerve. In both groups , The comfort of the patient with respect to positioning, The onset of sensory block (in minutes), the onset of motor block, and any complications also documented. |