| CTRI Number |
CTRI/2022/03/041040 [Registered on: 14/03/2022] Trial Registered Prospectively |
| Last Modified On: |
11/03/2022 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
an intervention to study the effect of blocking the popliteal sciatic nerve and saphenous nerve which will help surgeons to operate for below knee. |
|
Scientific Title of Study
|
Ultrasound guided popliteal sciatic and saphenous nerve block for patients undergoing below knee surgeries. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Shubham Jain |
| Designation |
RESIDENT |
| Affiliation |
.mahatama gandhi medical college and hospital |
| Address |
Mahatama gandhi medical college and hospital , sitapura tonk road riico industrial area, Jaipur
Jaipur
RAJASTHAN
302022
India |
| Phone |
9523936754 |
| Fax |
|
| Email |
shubhamkhajanchi08@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Durga Jethava |
| Designation |
HOD, Proffesor |
| Affiliation |
.mahatama gandhi medical college and hospital |
| Address |
Mahatama gandhi medical college and hospital , sitapura tonk road riico industrial area, Jaipur
Jaipur
RAJASTHAN
302022
India |
| Phone |
9680064336 |
| Fax |
|
| Email |
djethava@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Durga Jethava |
| Designation |
HOD, PROFESSOR |
| Affiliation |
.mahatama gandhi medical college and hospital |
| Address |
Mahatama gandhi medical college and hospital , sitapura tonk road riico industrial area, Jaipur
Jaipur
RAJASTHAN
302022
India |
| Phone |
9680064336 |
| Fax |
|
| Email |
djethava@gmail.com |
|
|
Source of Monetary or Material Support
|
| Mahatama gandhi medical college and hospital Jaipur |
|
|
Primary Sponsor
|
| Name |
Shubham jain |
| Address |
Mahatama gandhi medical college and hospital , sitapura tonk road riico industrial area, Jaipur |
| Type of Sponsor |
Other [self] |
|
|
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 Durga Jethava |
Mahatama Gandhi Medical College and Hospital, Ot complex,,department of Anaesthesia |
sitapura tonk road riico industrial area, Jaipur
Jaipur
RAJASTHAN |
9680064336
djethava@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee Mahtama Gandhi Medical College and Hospital |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: S829||Unspecified fracture of lower leg, (2) ICD-10 Condition: 8||Other Procedures, (3) ICD-10 Condition: O||Medical and Surgical, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
NOT APPLICABLE |
NOT APPLICABLE |
| Intervention |
Popliteal sciatic and Saphenous nerve block. |
Patients undergoing for below knee surgeries will be selected without any randomisation for ultra sound guided popliteal sciatic nerve and saphenous nerve block to be given as a sole anesthetic technique.The duration of block will be measured intraoperatively and postoperatively till first rescue analgesia is required. |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
ASA physical status I–IV (diabetes,hypertension, hepatorenal disease, ischemic heart disease),
aged 20–80 years scheduled for below knee surgeries will be enrolled in this prospective study
|
|
| ExclusionCriteria |
| Details |
Patients allergic to local anaesthetics,
on opioids and other analgesics for chronic pain
A refusal for peripheral nerve block
Neurological deficits
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To analyze the block success rate and onset time |
Intraoperatively |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Intraoperative hemodynamic parameters
Duration of postoperative analgesia
Patients overall satisfaction |
Upto 24hour postoperatively. |
|
|
Target Sample Size
|
Total Sample Size="50"
Sample Size from India="50"
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)
|
15/03/2022 |
| 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="0"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Central neuraxial blockade or spinal anesthesia remains an established technique for lower limb surgeries but with considerable hemodynamic changes specially in patient with associated comorbidities eg: diabetes, hypotension/hypertension. In addition many intraoperative complication can be faced such as hypotension , bradycardia , dyspnea, High/total spinal, shivering. All these complications can be curtailed with regional block and specifically ’ Saphenous nerve block along with popliteal sciatic nerve block for below knee surgeries. |