| CTRI Number |
CTRI/2025/07/090223 [Registered on: 04/07/2025] Trial Registered Prospectively |
| Last Modified On: |
01/07/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A Comparison of Two Methods for Numbing the Sciatic Nerve Behind the Knee (Popliteal Block) in Below-Knee Surgeries, One Using an Ultrasound to Guide the Injection from the Side and the Other from Lying on the Back, Along with a Thigh Nerve Block – A Study of How Each Method Works |
|
Scientific Title of Study
|
Ultrasound Guided Crosswise Approach of Popliteal Sciatic Block versus Supine Lateral Approach of Popliteal Sciatic Block for Below Knee Surgeries in Combination with Adductor Canal Block 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 BOYAPATI GOWTHAM KRISHNA |
| Designation |
1ST YR PG |
| Affiliation |
Aarupadai veedu medical college and hospital |
| Address |
DEPARTMENT OF ANESTHESIA 1ST FLOOR, A BLOCK, AARUPADI VEEDU MEDICAL COLLEGE AND HOSPITAL, KIRUMABAKKAM, PONDICHERRY
DEPARTMENT OF ANESTHESIA 1ST FLOOR, A BLOCK, AARUPADI VEEDU MEDICAL COLLEGE AND HOSPITAL, KIRUMABAKKAM, PONDICHERRY
Pondicherry
PONDICHERRY
607402
India |
| Phone |
9182353607 |
| Fax |
|
| Email |
gkboyapati1@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr V Haribabu |
| Designation |
PROFESSOR |
| Affiliation |
AVMCH |
| Address |
DEPARTMENT OF ANESTHESIA 1ST FLOOR, A BLOCK, AARUPADI VEEDU MEDICAL COLLEGE AND HOSPITAL, KIRUMABAKKAM, PONDICHERRY
DEPARTMENT OF ANESTHESIA 1ST FLOOR, A BLOCK, AARUPADI VEEDU MEDICAL COLLEGE AND HOSPITAL, KIRUMABAKKAM, PONDICHERRY
Pondicherry
PONDICHERRY
607402
India |
| Phone |
9442369647 |
| Fax |
|
| Email |
haribabu.veeraraghavan@avmc.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr VIJAYA KUMAR |
| Designation |
ASSISTAN PROFESSOR |
| Affiliation |
AARUPADI VEEDU MEDICAL COLLEGE AND HOSPITAL |
| Address |
DEPARTMENT OF ANESTHESIA 1ST FLOOR, A BLOCK, AARUPADI VEEDU MEDICAL COLLEGE AND HOSPITAL, KIRUMABAKKAM, PONDICHERRY
DEPARTMENT OF ANESTHESIA 1ST FLOOR, A BLOCK, AARUPADI VEEDU MEDICAL COLLEGE AND HOSPITAL, KIRUMABAKKAM, PONDICHERRY
Pondicherry
PONDICHERRY
607402
India |
| Phone |
8220202454 |
| Fax |
|
| Email |
vksekar28@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Anaesthesiology, first floor A block. Aarupadai Veedu
Medical College and Hospital. Kirumampakkam. Pondicherry
607402. India |
|
|
Primary Sponsor
|
| Name |
AARUPADAI VEEDU MEDICAL COLLEGE HOSPITAL |
| Address |
Department of Anaesthesiology, first floor A block. Aarupadai Veedu
Medical College and Hospital. Kirumampakkam. Pondicherry
607402. India |
| Type of Sponsor |
Private 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 BOYAPATI GOWTHAM KRISHNA |
AARUPADAI VEEDU MEDICAL COLLEGE AND HOSPITAL |
Department of
anaesthesiology first
floor aarupadai veedu
medical cololege and
hospital
kirumambakkam
Pondicherry
PONDICHERRY
Pondicherry
PONDICHERRY |
9182353607
gkboyapati1@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional human ethical committee aarupadai veedu medical college and hospital |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: S81||Open wound of knee and lower leg, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Crosswise approach of popliteal sciatic block |
Ultrasound guided Crosswise approach of popliteal sciatic block with Injection 0.5% Inj. Levobupivacaine 15ml with adductor canal block 0.25% Inj. Levobupivacaine 10ml. |
| Intervention |
Imaging time
Needling time
Time of onset of sensory block
Time of onset of motor block
Block failure
|
Block performance time is from contact of ultrasound probe to skin to the end of Levobupivacaine injection deposition.
Imaging time is interval between contact of the ultrasound probe with the patient and acquisition of a satisfactory image
Needling time is interval between skin infiltration and the end of local anaesthetic injection through the spinal needle
|
| Comparator Agent |
Lateral Approach of Popliteal Sciatic nerve block |
Ultrasound guided supine Lateral Approach of Popliteal Sciatic nerve block with 0.5% Inj. Levobupivacaine 15ml with adductor canal block 0.25% Inj. Levobupivacaine 10ml |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Patients of age group 18-60 years posted for elective Below Knee surgeries.
Patients with ASA 1,2,3.
|
|
| ExclusionCriteria |
| Details |
Patient refusal
allergy to the study drug
hemodynamic instability
local infection at the site of injection |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To compare block performance time of ultrasound guided crosswise popliteal sciatic nerve block and supine lateral popliteal sciatic nerve block |
24 hours |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To determine imaging time
To determine needling Time
To assess the time of onset of sensory block
To assess the time of onset of motor block
|
24 hours |
|
|
Target Sample Size
|
Total Sample Size="82"
Sample Size from India="82"
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)
|
01/08/2025 |
| 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="6"
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
|
Popliteal
sciatic nerve block in supine position
has been great regarding comfort to the patient. There are many approaches used
in supine position like supine medial, supine lateral approach but none of them
have been proved to be superior to one another. Supine lateral approach of
popliteal sciatic block is commonly performed in clinical practice and it is
associated with its own merits and
demerits. A new alternative approach to popliteal sciatic nerve block is
developed recently known as Crosswise approach of popliteal sciatic block (1).
In this study we are going to compare the block dynamics of Crosswise approach of popliteal sciatic nerve
block and supine lateral approach of popliteal sciatic nerve block approaches. |