| CTRI Number |
CTRI/2024/04/065883 [Registered on: 18/04/2024] Trial Registered Prospectively |
| Last Modified On: |
16/04/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
USG versus PNS guided Femoral Nerve Block for ease of positioning for Spinal Anaesthesia in Fracture Femur patients |
|
Scientific Title of Study
|
Nerve stimulator versus ultrasound guided Femoral nerve block for ease of positioning before spinal anaesthesia in fracture femur patients-A Randomized comparative 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 |
Ponugupati Gopichand |
| Designation |
Jr.Resident |
| Affiliation |
Rangaraya Medical College |
| Address |
Department of Anaesthesiology,
Government General Hospital,
Kakinada
East Godavari
ANDHRA PRADESH
533001
India |
| Phone |
7993020705 |
| Fax |
|
| Email |
dr.gopichandponugupati@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Athaluri Vishnu Vardhan |
| Designation |
Professor and Head of Department |
| Affiliation |
Rangaraya Medical College |
| Address |
Department of Anaesthesiology,
Government General Hospital,
Kakinada
East Godavari
ANDHRA PRADESH
533001
India |
| Phone |
9849577999 |
| Fax |
|
| Email |
athalurivishnu@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Pongupati Gopichand |
| Designation |
Jr.Resident |
| Affiliation |
Rangaraya Medical College |
| Address |
Department of Anaesthesiology,
Government General Hospital,
Kakinada
East Godavari
ANDHRA PRADESH
533001
India |
| Phone |
7993020705 |
| Fax |
|
| Email |
dr.gopichandponugupati@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Anaesthesiology, Rangaraya Medical College, Kakinada, East Godavari - 533001 |
|
|
Primary Sponsor
|
| Name |
Ponugupati Gopichand |
| Address |
Department of Anaesthesiology, Rangaraya Medical College, Kakinada |
| 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 |
| Gopichand Ponugupati |
Government General Hospital, Kakinada |
Orthopedics Operation Theatre Complex,
Department of Anaesthesiology, Rangaraya Medical College, Kakinada.
East Godavari
ANDHRA PRADESH |
7993020705
Dr.gopichandponugupati@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Rangaraya Medical College Institutional Ethics Committee Cell |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M00-M99||Diseases of the musculoskeletal system and connective tissue, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Peripheral Nerve Stimulator guided Femoral Nerve Block |
15ml 0.5% Ropivacaine + 14ml 2% Lignocaine with Adrenaline (1:2,00,000) + 1ml Dexamethasone (4mg/ml) given once unilaterally |
| Intervention |
Ultrasound guided Femoral Nerve Block |
15ml 0.5% Ropivacaine + 14ml 2% Lignocaine with Adrenaline (1:2,00,000) +1ml Dexamethasone (4mg/ml) given once unilaterally |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
ASA Grade1 and Grade2
Elective surgeries |
|
| ExclusionCriteria |
| Details |
1.Histosry of allergy and sensitivity to any local
anaesthetics
2.pregnant women
3.Bleeding disorders |
|
|
Method of Generating Random Sequence
|
Stratified block randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Onset time |
During surgery & postoperative day 1 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Success rate,performance time,number of needle passes ,incidence of adverse effects |
During surgery & postoperative day 1 |
|
|
Target Sample Size
|
Total Sample Size="120"
Sample Size from India="120"
Final Enrollment numbers achieved (Total)= "120"
Final Enrollment numbers achieved (India)="120" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
01/06/2024 |
| Date of Study Completion (India) |
01/03/2025 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="6"
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
|
Movement and positioning of patients with fracture femur before regional anaesthesia is extremly painful as evident from preoperative baseline VAS scores observed in study.The effected leg abducted and painted with 5%povidone iodine.the inguinal ligament is identified and marked .the femoral artery is palpated and marked ,a nerve stimulating needle is inserting at 45 degrees just lateral to femoral artery.the current is initially started at 2 millivolts using a nerve stimulator and then after checking the proper response of quadriceps muscle contraction.it is reduced to 0.3 to 0.5 millivolts .ultrasonography guided femoral nerve block is given in the middle of the inguinal ligament and after setting the optimal gain ,depth,and focal point of the ultrasound femoral artery visualised .the probe was then moved laterally ,medially and back and forth till a clear femoral nerve seen as a hyperechoic triangular shaped structure immediately lateral to femoral artery. |