| CTRI Number |
CTRI/2022/12/048224 [Registered on: 19/12/2022] Trial Registered Prospectively |
| Last Modified On: |
15/12/2022 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A Clinical Trial To Study The Effect Of Fascia Iliaca Compartment Block On The Incidence Of Post Operative Delirium In Hip Surgery |
|
Scientific Title of Study
|
"A Comparative Study Of The Analgesic Efficacy Of Fascia Iliaca Compartment Block( FIACB) And Its Effect On The Incidence Of Post Operative Delirium(POD) In Patients Undergoing Hip Surgery With Subarachnoid Block(SAB)- A Prospective Randomised Controlled Single Blinded Study" |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Mayukh Chattopadhyay |
| Designation |
Assistant Professor |
| Affiliation |
KPC Medical College & Hospital |
| Address |
Room No-203, Department Of Anaesthesiology, KPC Medical College & Hospital
Room No-203, Department Of Anaesthesiology, KPC Medical College & Hospital
Kolkata
WEST BENGAL
700032
India |
| Phone |
9831270765 |
| Fax |
|
| Email |
mayukhchat@yahoo.co.uk |
|
Details of Contact Person
Scientific Query
|
| Name |
Mayukh Chattopadhyay |
| Designation |
Assistant Professor |
| Affiliation |
KPC Medical College & Hospital |
| Address |
Room No-203, Department Of Anaesthesiology, KPC Medical College & Hospital
Room No-203, Department Of Anaesthesiology, KPC Medical College & Hospital
Kolkata
WEST BENGAL
700032
India |
| Phone |
9831270765 |
| Fax |
|
| Email |
mayukhchat@yahoo.co.uk |
|
Details of Contact Person
Public Query
|
| Name |
Mayukh Chattopadhyay |
| Designation |
Assistant Professor |
| Affiliation |
KPC Medical College & Hospital |
| Address |
Room No-203, Department Of Anaesthesiology, KPC Medical College & Hospital
Room No-203, Department Of Anaesthesiology, KPC Medical College & Hospital
Kolkata
WEST BENGAL
700032
India |
| Phone |
9831270765 |
| Fax |
|
| Email |
mayukhchat@yahoo.co.uk |
|
|
Source of Monetary or Material Support
|
| KPC Medical College & Hospital
1F Raja S.C. Mullick Road
Jadavpur
Kolkata-700032 |
|
|
Primary Sponsor
|
| Name |
KPC Medical College & Hospital |
| Address |
Dept. Of Anaesthesiology, Room No 203,KPC Medical College & Hospital |
| 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 Prof Subrata Ray |
KPC Medical College & Hospital |
Dept. Of Anaesthesiology, Room No 203,KPC Medical College & Hospital
Kolkata
WEST BENGAL |
9674330016
raysubrata62@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M169||Osteoarthritis of hip, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Fascia Iliaca Block |
Visual Analogue Score And Confusion Assessment Methods Scoring Every 6Hrs upto 48Hrs. |
| Comparator Agent |
NIl |
NIL |
|
|
Inclusion Criteria
|
| Age From |
50.00 Year(s) |
| Age To |
85.00 Year(s) |
| Gender |
Both |
| Details |
ASA Class I
ASA Class II
ASA Class III
ASA Class IV |
|
| ExclusionCriteria |
| Details |
Coagulation Disorder
Patient Refusal
Past History Of Local Anaesthetic Toxicity |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Confusion Assessment Methods Scoring (CAM)- To Be Assessed 6Hrs Post Operatively And Every 6Hrs Thereafter For The First 48Hrs Immediately Post Surgery |
Confusion Assessment Methods Scoring (CAM) 6Hrs Post Surgery(Baseline), 12Hrs, 18Hrs, 24Hrs, 30Hrs, 36Hrs, 42Hrs & 48 Hrs |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Analgesic Efficacy Of Fascia Iliaca Compartment Block As A Mode Of Post Operative Analgesia |
6Hrs to 48Hrs |
|
|
Target Sample Size
|
Total Sample Size="180"
Sample Size from India="180"
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
|
N/A |
|
Date of First Enrollment (India)
|
21/12/2022 |
| 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="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
|
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Post Operative Delirium (POD) is a common complication after hip surgeries with a median incidence of about 15%, leading to increased hospital stay and other medical complications. Hip fracture surgeries are one of the most common surgical interventions in the elderly population. Subarachnoid block (SAB) with Fascia Iliaca Compartment Block ( FIACB) as a mode of post operative analgesia has the potential to reduce the incidence of post operative delirium by lowering the level of liberated pro-inflammatory cytokines. FIACB, when used to supplement conventional systemic analgesia in the post operative period after hip fracture may reduce the incidence of POD. However there is uncertainty ( equipoise ) about its effectiveness.
To assess the effectiveness of fascia iliaca compartment block in reducing the incidence of POD when added to conventional systemic analgesics. |