| CTRI Number |
CTRI/2020/02/023285 [Registered on: 13/02/2020] Trial Registered Prospectively |
| Last Modified On: |
02/02/2021 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
Decrease in amount of pain killer after surgery |
|
Scientific Title of Study
|
EFFECT OF TRANSVERSALIS FASCIA PLANE BLOCK ON POST OPERATIVE ANALGESIA IN ILIAC CREST BONE GRAFTING FOR UPPER LIMB SURGERY, A TRIPLE BLIND RANDOMISED CONTROLLED TRIAL |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| Nil |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Anita kumari |
| Designation |
MD. ANAESTHESIOLOGY |
| Affiliation |
Indira Gandhi Institute of medical Sciences |
| Address |
Dept. Anaesthesiology
I.G.I.M.S. Sheikhpura, Patna
Pin-800014
Yadein marriage hall, behind Ramrajatala apartment , Brahmsthani Gail near I.G.I.M.S. Patna
Patna
BIHAR
800014
India |
| Phone |
6201103013 |
| Fax |
|
| Email |
dranita2092@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Anita kumari |
| Designation |
MD. ANAESTHESIOLOGY |
| Affiliation |
Indira Gandhi Institute of medical Sciences |
| Address |
Dept. Anaesthesiology
I.G.I.M.S. Sheikhpura, Patna
Pin-800014
Yadein marriage hall, behind Ramrajatala apartment , Brahmsthani Gail near I.G.I.M.S. Patna
Patna
BIHAR
800014
India |
| Phone |
6201103013 |
| Fax |
|
| Email |
dranita2092@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Swati |
| Designation |
Associate professor in department of AnaesthesiologyI IGIMS |
| Affiliation |
Indira Gandhi Institute of medical Sciences, in Department of anaesthesiology |
| Address |
Department of anaesthesiology 1st floor, near OT complex
Indira gandhi institute of medical sciences, sheikhpura, Patna 800014
Patna
BIHAR
800014
India |
| Phone |
8544413241 |
| Fax |
|
| Email |
deepakswat@yahoo.com |
|
|
Source of Monetary or Material Support
|
| Indira Gandhi institute of medical sciences,Sheikhpura Patna 800014 |
|
|
Primary Sponsor
|
| Name |
Indira Gandhi institute of medical sciencesSheikhpura Patna |
| Address |
Department of Anaesthesiology 1st floor in ward block, I.G.I.M.S. PATNA
PIN-800014 |
| Type of Sponsor |
Government 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 |
| Anita kumari |
Indira gandhi institute of medical sciences |
Department of anaesthesia 1st floor ward block near Neuro OT
Patna
BIHAR |
6201103013
dranita2092@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethics committee,Igims, patna |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M248||Other specific joint derangements,not elsewhere classified, (2) ICD-10 Condition: M218||Other specified acquired deformities of limbs, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Transversalis fascia plane block |
After pt selection and informed consent pt will receive 20ml of 5%dextrose solution in, USG-guided TFP block. |
| Intervention |
Transversalis fascia plane block |
After pt. selection and inform consent, the pt. will receive drug A(which will contain 20ml of 0.5m% bupivacaine+1:200000 epinephrine) in USG guided TFP block. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
85.00 Year(s) |
| Gender |
Both |
| Details |
Scheduled for elective upper limb surgery, which can be solely performed under a brachial plexus block,and requiring ICBG |
|
| ExclusionCriteria |
| Details |
1)Contraindications to regional blockade (eg. Allergy to local anaesthetic,coagulopathy,malignancy or infection in the area)
2)Pregnancy
3)History of alcohol or drug dependence/abuse
4)History of long term opioid intake or chronic pain disorder.
5)History of significant psychiatric condition that may affect patient assessment.
6)Failure of upper extremity block.
7)Previous iliac crest bone grafting.
8)Inability to informed consent and demands of the study. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant, Investigator and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
1)opioid consumption (time frame 24hrs)
Opioid consumption in first 24hrs following ICBG. this will measure in terms of mg dose of IV morphine. |
First 24hrs |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1)Pain measure
2)Time of block performance
3)Complications |
First 24hrs |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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 3 |
|
Date of First Enrollment (India)
|
18/02/2020 |
| 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="2"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
Not yet published |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
Brief Summary
Modification(s)
|
This study is prospective randomised triple blind control trial; in which20ml 0.5%bupivacaine is given in transversalis fascia plane block in Study group and 20ml of 5% dextrose is given as LA in TFP block in control group then effectiveness of TFP block will analyse in reduction of morphine use during post operative period. |