| CTRI Number |
CTRI/2024/11/076388 [Registered on: 08/11/2024] Trial Registered Prospectively |
| Last Modified On: |
08/11/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparing Two Ways to Block Nerve Pain for Below-Knee Surgery: Lying on Your Back vs. Lying on Your Side |
|
Scientific Title of Study
|
Comparison of ultrasound guided supine (crosswise approach to popliteal sciatic nerve- CAPS) and lateral approaches to popliteal sciatic nerve block for below knee surgeries |
| 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 Aishath Soifa Shareef |
| Designation |
Junior resident in department of Anesthesiology |
| Affiliation |
KMC, MAHE Manipal |
| Address |
Department of anesthesiology, Kasturba medical college, MAHE, Manipal, Udupi
Udupi
KARNATAKA
576104
India |
| Phone |
7411754647 |
| Fax |
|
| Email |
shareefsoipha@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Anitha Nileshwar |
| Designation |
Professor Department of Anesthesiology |
| Affiliation |
KMC, MAHE Manipal |
| Address |
Department of anesthesiology, Kasturba medical college, MAHE, Manipal, Udupi
Udupi
KARNATAKA
576104
India |
| Phone |
9880842121 |
| Fax |
|
| Email |
anitharshenoy@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Anitha Nileshwar |
| Designation |
Professor Department of Anesthesiology |
| Affiliation |
KMC, MAHE Manipal |
| Address |
Department of anesthesiology, Kasturba medical college, MAHE, Manipal, Udupi
KARNATAKA
576104
India |
| Phone |
9880842121 |
| Fax |
|
| Email |
anitharshenoy@gmail.com |
|
|
Source of Monetary or Material Support
|
| Self
Department of Anaesthesia, KMC Manipal, Udupi, Karnataka, India, 576104 |
|
|
Primary Sponsor
|
| Name |
Aishath Soifa Shareef |
| Address |
Department of Anesthesiology, Kasturba medical college, MAHE, Manipal, Udupi, India, 576104 |
| 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 Aishath Soifa Shareef |
Kasturba Medical College, manipal |
Department of Anesthesiology, Kasturba medical college, MAHE, Manipal, Udupi
Udupi
KARNATAKA |
7411754647
shareefsoipha@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Kasturba medical college and kasturba hospital institutional ethics committee |
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 |
Positioning patient in lateral position |
Group L will be in lateral position and nerve will be first scanned and visibility scoring noted
After that number of needle passes to reach the nerve and depth of nerve and time to onset of block will be recorded |
| Intervention |
Positioning patient in supine position. |
Group S will be in supine position and nerve will be first scanned and visibility scoring noted
After that number of needle passes to reach the nerve and depth of nerve and time to onset of block will be recorded |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
ASA PS I - III
Patients scheduled to undergo procedures below knee and not requiring application of a tourniquet
|
|
| ExclusionCriteria |
| Details |
Hemodynamically unstable patients
Patients in ketoacidosis
Known allergy to local anesthetics
Known bleeding tendencies
Infection at the site of injection
|
|
|
Method of Generating Random Sequence
|
|
|
Method of Concealment
|
|
|
Blinding/Masking
|
|
|
Primary Outcome
|
| Outcome |
TimePoints |
| Visibility score of sciatic nerve |
At the time of scanning inside OT |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Time taken to identify sciatic nerve visually
|
Observer 1 Postgraduate will record the time from start of scanning to identifying the nerve |
| Nerve depth |
Measured when an appropriate image is seen on screen just before giving the block |
| Number of needle passes |
Number of times the needle has to be passed to reach the nerve to give the block |
| Time taken for onset of block |
From the time of giving the drug to the time of loss of pain sensation |
| Complications |
from the time of giving block till the end of surgery |
|
|
Target Sample Size
|
Total Sample Size="78"
Sample Size from India="78"
Final Enrollment numbers achieved (Total)= "44"
Final Enrollment numbers achieved (India)="44" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
20/11/2024 |
| Date of Study Completion (India) |
30/04/2025 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="2"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
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 popliteal sciatic nerve block (PSNB) is a commonly practiced regional anesthesia technique well-suited to provide anesthesia or analgesia for below-knee surgeries. The ultrasound guided PSNB is usually performed in the prone or lateral position. However, in various conditions such as spine injury, morbid obesity, hemodynamic instability and pregnancy it may not be feasible to position the patient in a prone or lateral position. Improper positioning may then lead to an inadequate or failed block. This may require conversion to spinal or general anesthesia which is usually not ideal as it increases the possibility of hemodynamic fluctuations. Therefore, in our study we will be comparing the lateral approach and supine approach in giving the PSNB. Supine position will eliminate the difficulties faced in other positions for the patient and the anesthetist. We expect the supine approach to be just as easy, effective and safe method of providing PSNB. |