| CTRI Number |
CTRI/2020/02/023567 [Registered on: 25/02/2020] Trial Registered Prospectively |
| Last Modified On: |
05/08/2021 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Follow Up Study |
| Study Design |
Other |
|
Public Title of Study
|
To compare the difference between Femoral nerve block with an adjuvant (dexmedetomidine ) and Adductor canal block with the same adjuvant in reducing the postoperative pain after total knee arthroplasty |
|
Scientific Title of Study
|
Comparison of Femoral nerve block with Dexmendetomidine versus Adductor canal block with Dexmedetomidine for postoperative analgesia for total knee arthroplasty |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Neha Daniel George |
| Designation |
Postgraduate in MD Anaesthesiology |
| Affiliation |
Kasturba medical college , Mangalore |
| Address |
203 ,
Department of Anaesthesiology ,
Kasturba medical college Light house hill road , Hampankatta ,
Mangalore
Dakshina Kannada
KARNATAKA
575001
India |
| Phone |
9535365210 |
| Fax |
|
| Email |
nehadg23@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sonal Bhat |
| Designation |
Associate professor |
| Affiliation |
Kasturba medical college , Mangalore |
| Address |
Kasturba Medical College , Mangalore
Dakshina Kannada
KARNATAKA
575001
India |
| Phone |
9980014995 |
| Fax |
|
| Email |
sonalbhat27@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Neha Daniel George |
| Designation |
Postgraduate in MD Anaesthesiology |
| Affiliation |
Kasturba medical college , Mangalore |
| Address |
203 ,
Department of Anaesthesiology ,
Kasturba medical college Light house hill road , Hampankatta ,
Mangalore
Dakshina Kannada
KARNATAKA
575001
India |
| Phone |
9535365210 |
| Fax |
|
| Email |
nehadg23@gmail.com |
|
|
Source of Monetary or Material Support
|
| Kasturba Medical College Mangalore |
|
|
Primary Sponsor
|
| Name |
Kasturba medical college |
| Address |
203 , Light house hill road
Hampankatta , Mangalore
Karnataka |
| 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 Neha Daniel George |
KMC Hospitals |
Government Wenlock hospital , Milagres road
Kmc Hospital , Jyothi circle
KMC hospital , Nandigudda road, Mangalore
Dakshina Kannada
KARNATAKA |
9535365210
nehadg23@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, Kasturba Medical College , Mangalore |
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
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
ASA physical status I, II and Emergency patientswho are Planned for lower limb surgeries
|
|
| ExclusionCriteria |
| Details |
1. Patient’s refusal
2. History of allergy to local anaesthetics
3. Coagulopathy or Bleeding diathesis
4. H/o peripheral neuropathy
5. Previous femoral bypass surgery
6. Inguinal hernia
7. Local skin infection
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Postoperative analgesic efficacy of Femoral nerve Block with dexmedetomidine as an adjuvant and Adductor canal block with dexmedetomidine as an adjuvant |
JULY 2021 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Mean arterial Blood pressure
Heart rate
Rescue analgesia time |
july 2021 |
|
|
Target Sample Size
|
Total Sample Size="140"
Sample Size from India="140"
Final Enrollment numbers achieved (Total)= "140"
Final Enrollment numbers achieved (India)="0" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
01/03/2020 |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
30/06/2021 |
|
Estimated Duration of Trial
|
Years="2"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
Not published |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
Brief Summary
Modification(s)
|
To compare the efficacy of Femoral nerve block with dexmedetomidine and Adductor canal block with dexmedetomidine as an adjuvant in providing post-operative analgesia in patients undergoing Total knee arthroplasty . This helps to provide alternate mode of analgesia that can be made use in patients who cannot be given coventional methods of anaesthesia . . |