| CTRI Number |
CTRI/2024/10/076011 [Registered on: 29/10/2024] Trial Registered Prospectively |
| Last Modified On: |
28/10/2024 |
| 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
|
To compare the efficacy of Dexmedetomidine added to Ropivacaine in USG guided suprainguinal fascia iliaca block for peri-operative pain management in patients of trochanteric fractures. |
|
Scientific Title of Study
|
To evaluate the clinical efficacy of Dexmedetomidine as an adjuvant to Ropivacaine in USG guided suprainguinal fascia iliaca block for peri-operative analgesia in patients of trochanteric fractures. |
| Trial Acronym |
nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Shweta Bhatia |
| Designation |
Junior Resident |
| Affiliation |
DR RPGMC TANDA Kangra HIMACHAL PRADESH |
| Address |
Room number 101 operation theatre complex 3rd floor Department of Anaesthesia DR RPGMC TANDA, Kangra, HIMACHAL PRADESH
Kangra
HIMACHAL PRADESH
176001
India |
| Phone |
7876492523 |
| Fax |
|
| Email |
shweta.bhatia1711@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Nanish Sharma |
| Designation |
Assistant Professor |
| Affiliation |
Dr RPGMC TANDA Kangra Himachal Pradesh |
| Address |
Department of Anaesthesia Dr RPGMC TANDA Kangra Himachal Pradesh
Kangra
HIMACHAL PRADESH
176001
India |
| Phone |
8727049007 |
| Fax |
|
| Email |
nanish.sharma26@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Nanish Sharma |
| Designation |
Assistant Professor |
| Affiliation |
DR RPGMC TANDA Kangra HIMACHAL PRADESH |
| Address |
Department of Anaesthesia Dr RPGMC TANDA Kangra Himachal Pradesh
Kangra
HIMACHAL PRADESH
176001
India |
| Phone |
8727049007 |
| Fax |
|
| Email |
nanish.sharma26@gmail.com |
|
|
Source of Monetary or Material Support
|
| Dr RPGMC Tanda Kangra Himachal Pradesh |
|
|
Primary Sponsor
|
| Name |
Shweta Bhatia |
| Address |
Department of Anaesthesia, DR RPGMC TANDA , Kangra, HIMACHAL PRADESH ,176001 |
| 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 |
| Dr Shweta Bhatia |
Dr Rajender Prasad Government Medical College And HospitalTANDA Kangra HIMACHAL PRADESH |
Room Number 101 Operation theatre complex 3rd floor pre-operative room department of anaesthesia DR RPGMC TANDA Kangra Himachal Pradesh
Kangra
HIMACHAL PRADESH |
7876492523
shweta.bhatia1711@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| DR RPGMC TANDA , KANGRA, HIMACHAL PRADESH , 176001 |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O||Medical and Surgical, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Dexmedetomidine with ropivacaine |
28ml of 0.25%ropivacaine with 0.5microgram/ kg in USG guided suprainguinal fascia iliaca block .The total duration of the study will be 12 months |
| Comparator Agent |
ropivacaine with normal saline |
28ml of 0.25% ropivacaine with 2ml normal saline in USG guided suprainguinal fascia iliaca block The total duration of study will be 12 months |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
1. ASA PS I TO III
2. BMI 18.5 -29.9
3. Patients with trochanteric fracture who will be scheduled to undergo fixation of fracture ( intertrochanteric and subtrochanteric ) under spinal anaesthesia. |
|
| ExclusionCriteria |
| Details |
1. patients refusal to participate in study
2. patients with anatomical spinal deformities.
3. patient with bleeding disorders and raised intracranial pressure.
4. patient with local infection at the sites where needle for spinal is to be inserted and altered anatomy like inguinal hernia, and femoral artery graft.
5. patients with dysrhythmias.
6. patients allergic to study drugs.
7. patients on anticoagulants, polytrauma.
8. failure of soinal anesthesia.
9. trochanteric femoral fractures associated with other fractures . |
|
|
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 |
| VAS at rest and on passive external rotation of the limb 20 minutes after the block and EOSP. |
20 minutes |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
total duration of analgesia
amount of tramadol used
patient satisfaction score
|
6 hours,12 hours,24 hours |
|
|
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 4 |
|
Date of First Enrollment (India)
|
08/11/2024 |
| 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
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - YES
- What data in particular will be shared?
Response - All of the individual participant data collected during the trial, after de-identification.
- What additional supporting information will be shared?
Response - Study Protocol
Response - Statistical Analysis Plan
Response - Informed Consent Form
Response - Clinical Study Report
- Who will be able to view these files?
Response - Researchers who provide a methodologically sound proposal.
- For what types of analyses will this data be available?
Response - To achieve aims in the approved proposal.
- By what mechanism will data be made available?
Response - Data are available indefinitely at (Link to be included shweta.bhatia1711@gmail.com).
- For how long will this data be available start date provided 01-01-2026 and end date provided 01-01-2030?
Response - Immediately following publication. No end date.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - nil
|
|
Brief Summary
|
we are comparing the efficacy of dexmedetomidine0.5micrograms / kg and 0.25%ropivacaine with 0.25 %ropivacaine in USG guided suprainguinal fascia iliaca block in patients of trochanter fractures for peri-operative pain management .the block will be given in preoperative room and after 20 minutes pain score will be noted and ease of positioning for spinal will be noted . the pain score and vitals will be recorded in the post operative period |