| CTRI Number |
CTRI/2024/09/073447 [Registered on: 05/09/2024] Trial Registered Prospectively |
| Last Modified On: |
04/09/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Parasacral ischial plane block with femoral block in high risk patients of below knee surgery
|
|
Scientific Title of Study
|
Parasacral Ischial Plane Block With Femoral Block In High Risk Patients Of Below Knee Surgery A Prospective Observational 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 |
DrKumudSGanvit |
| Designation |
Assistant professor in Department of Anaesthesiology |
| Affiliation |
Government Medical College Baroda |
| Address |
Department: Anaesthesiology, Division: OT block
Room on 2nd floor
Government medical college Baroda,
Gujrat
Vadodara
GUJARAT
390001
India |
| Phone |
9825607625 |
| Fax |
|
| Email |
drkumudsganvit@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DrKumudSGanvit |
| Designation |
Assistant professor in Department of Anaesthesiology |
| Affiliation |
Government Medical College Baroda |
| Address |
Department :Anaesthesiology, Division: OT block , Room on 2nd floor
Government medical college Baroda,
Gujrat
GUJARAT
390001
India |
| Phone |
9825607625 |
| Fax |
|
| Email |
drkumudsganvit@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DrGovind M Ramsena |
| Designation |
Resident doctor in Department of Anaesthesiology |
| Affiliation |
Government Medical College Baroda |
| Address |
Department :Anaesthesiology, Division: OT block , Room on 2nd floor
Government medical college Baroda,
Gujrat
Vadodara
GUJARAT
390001
India |
| Phone |
7621041968 |
| Fax |
|
| Email |
govindramsena@gmail.com |
|
|
Source of Monetary or Material Support
|
| Government medical College baroda,Vadodara -390001
Gujarat,india |
|
|
Primary Sponsor
|
| Name |
Government Medical College Baroda |
| Address |
Government Medical College Baroda,vinoba bhave road,Anandpura,Vadodara-390001
Gujarat india |
| Type of Sponsor |
Government medical college |
|
|
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 Govind Ramsena |
Ssg Hospital Vadodara |
Department: Anaesthesiology
Division: OT block
Room : 2nd floor
Vadodara
GUJARAT |
7621041968
govindramsena@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee For Biomedical And Health Research, Government Medical College Baroda |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: S90-S99||Injuries to the ankle and foot, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Not applicable |
Not applicable |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
1.Age group: 18 to 70 years
2.Either sex
3.ASA grading: III,IV
4.Patient posted for planned/emergency below knee surgeries [General surgery and Orthopedic surgery]
5.Patient able to understand VAS regarding assessment of pain
|
|
| ExclusionCriteria |
| Details |
1. Inability or refusal to follow the study protocol
2. Coagulopathy
3. Local Infection
4. Progressive Neurological Disorder
5.Bilateral lower limb surgery
6.Patient with pelvic fracture because of position problems.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
To monitor hemodynamic stability in terms of Pulse rate,Systolic blood
pressure,Diastolic blood pressure Mean arterial pressure and spo2. |
At baseline |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. Sensory block:
• Onset time, Peak effect, Duration of sensory block
2. Motor block:
• Onset time, Peak effect, Duration of motor block
3. Duration of analgesia
4. Peri-operative complication like Hematoma,Neuropraxia,Local
anaesthetic toxicity,etc |
Till 24 hr |
|
|
Target Sample Size
|
Total Sample Size="70"
Sample Size from India="70"
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)
|
15/09/2024 |
| 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 Yet Recruiting |
| 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 aim of our study is to monitor hemodynamic stability in terms of pulse rate, systolic blood pressure, diastolic blood pressure,mean arterial pressure and oxygen saturation.70 high risk ASA III,IV patients of below knee surgeries will be taken and parasacral ischial plane block with femoral block will be given with USG and peripheral nerve stimulator.Along with onset time,peak effect and duration of sensory and motor block , duration of analgesia and peri operative complications will be noted. |