| CTRI Number |
CTRI/2017/11/010682 [Registered on: 28/11/2017] Trial Registered Retrospectively |
| Last Modified On: |
27/11/2017 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
A Prospective Randomised Controlled Study. |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A study to compare two different nerve blocks for lower limb, namely, Femoral Nerve Block & Adductor Canal Nerve Block, to find pain relief provided by them after knee arthroscopic ligament surgery.
|
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Scientific Title of Study
|
Comparison of analgesic efficacy of Femoral Nerve Block Vs Adductor Canal Block as a part of multimodal analgesia for patients undergoing elective knee arthroscopic ACL surgery-A Prospective , Randomised, Controlled Study. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Shikha Tiwari |
| Designation |
DNB Resident |
| Affiliation |
Ganga Hospital, Coimbatore, Tamilnadu |
| Address |
Department of Anaesthesia, 5th floor, College building, Ganga Hospital, Coimbatore
Coimbatore
TAMIL NADU
641043
India |
| Phone |
|
| Fax |
|
| Email |
drshikhatiwari@yahoo.com |
|
Details of Contact Person
Scientific Query
|
| Name |
R Manikandan Raja Rathinam |
| Designation |
Consultant, Dept. of Anaesthesia |
| Affiliation |
Ganga hospital Coimbatore |
| Address |
No.303, Mettupalayam Road, Saibaba Koil, Coimbatore
No 303, mettupalayam road. Near San baba Mandir Coimbatore
Coimbatore
TAMIL NADU
641043
India |
| Phone |
9442649323 |
| Fax |
914222451444 |
| Email |
drmani.ab8@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Shikha Tiwari |
| Designation |
DNB Resident |
| Affiliation |
Ganga Hospital, Coimbatore, Tamilnadu |
| Address |
5th Floor, Dept. of Anaesthesia, Ganga Hospital, Coimbatore.
Coimbatore
TAMIL NADU
641043
India |
| Phone |
|
| Fax |
|
| Email |
drshikhatiwari@yahoo.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Ganga hospital |
| Address |
Ganga hospital and research centre , sai baba koil coimbatore tamilnadu |
| Type of Sponsor |
Private hospital/clinic |
|
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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 |
| Shikha Tiwari |
Ganga Hospital,coimbatore |
OT complex, 5th floor, Hospital building
Coimbatore
TAMIL NADU |
8879135204
drshikhatiwari@yahoo.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional review board and scientific committee Ganga medical centre andhospital |
Approved |
|
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Regulatory Clearance Status from DCGI
|
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Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
Age group 18-60 years
Either sex
Physical Status ASA I and II grading
Patient posted for elective surgical procedure for knee arthroscopy for ACL reconstruction, |
|
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Intervention / Comparator Agent
|
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Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Age group 18-60 years, Either sex, Physical Status ASA I and II grading , Patient posted for elective surgical procedure for knee arthroscopy for ACL reconstruction
|
|
| ExclusionCriteria |
| Details |
Known hypersensitivity to local anaesthetics
Non consenting patients
DM
Infection at site of injection
Previous history of PONV{post operative nausea vomiting}
Coagulopathy / Bleeding disorders
Existing peripheral neuropathyÂ
|
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Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Use of peripheral nerve block for post operative analgesia like femoral and adductor canal nerve block in arthroscopic knee surgery decreases VAS score, provides superior analgesia, helps in mobilization with out pain. It also reduces associated complication of opioid analgesic.Adductor canal block provides accepted pain relief with out motor blockade , which helps in safe mobilization with out risk of fall. |
After 15 minutes of drug injection for nerve block |
|
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Secondary Outcome
|
| Outcome |
TimePoints |
| Use of nerve block is superior to spinal anaesthesia alone. |
From post op zero hr to 48 hr |
|
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Target Sample Size
|
Total Sample Size="150"
Sample Size from India="150"
Final Enrollment numbers achieved (Total)= "150"
Final Enrollment numbers achieved (India)="150" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
24/03/2015 |
| Date of Study Completion (India) |
12/12/2015 |
| 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
|
Not yet published |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
analgesic efficacy of USG guided Adductor canal block and USG guided Femoral nerve block was found to be superior than spinal anesthesia alone, and Adductor canal block is better block is better than Femoral nerve block in patients under going arthroscopic knee surgery as it provides adequate analgesia and no motor blockade which helps in mobilization with out risk of fall. |