| CTRI Number |
CTRI/2025/12/099343 [Registered on: 17/12/2025] Trial Registered Prospectively |
| Last Modified On: |
16/12/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Injection treatment for hip fracture surgery |
|
Scientific Title of Study
|
Single blind randamized control trial comparing injection bupivacaine with dexamethasone versus injection bupivacaine with dexmedetomidine in suprainguinal fascia iliaca block for postoperative pain relief in fracture hip surgery |
| 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 Megha Sonawane |
| Designation |
Assistant professor |
| Affiliation |
|
| Address |
Department of Anaesthsia,Room No.111,First floor,Hospital building,MIMER Medical college,Talegaon Dabhade
Pune
MAHARASHTRA
410507
India |
| Phone |
9158104000 |
| Fax |
|
| Email |
drmeghasonavane@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Megha Sonawane |
| Designation |
Assistant professor |
| Affiliation |
|
| Address |
Department of Anaesthesia,Room no.111,First floor,Hospital building,MIMER Medical college,Talegaon Dabhade
Pune
MAHARASHTRA
410507
India |
| Phone |
9158104000 |
| Fax |
|
| Email |
drmeghasonavane@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Megha Sonawane |
| Designation |
Assistant Professor |
| Affiliation |
|
| Address |
Department of Anaesthesia,Room no.111,First floor,Hospital building,MIMER Medical college,Talegaon Dabhade
Pune
MAHARASHTRA
410507
India |
| Phone |
9158104000 |
| Fax |
|
| Email |
drmeghasonavane@gmail.com |
|
|
Source of Monetary or Material Support
|
| MIMER Medical College,Talegaon Dabhade,Mawal,Pune,Maharashtra,India,pincode 410507 |
|
|
Primary Sponsor
|
| Name |
MIMER Medical College |
| Address |
A&P Talegaon Dabhade,Mawal,Dist Pune,Maharashtra,India ,pincode 410507 |
| 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 Megha Sonawane |
MIMER Medical college |
Department of Anaesthesia,Room no.111,First floor,Hospital building Talegaon Dabhade
Pune
MAHARASHTRA |
9158104000
drmeghasonavane@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| MIMER Medical College IEC |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Fracture hip |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Injection Bupivacaine with Dexamethasone
|
comparator arm:Patient will receive Injection bupivacaine with dexamethasone administered in suprainguinal fascia iliaca block.
drug: Bupivacaine with dexmethasone
dosage and route:0.25 persent bupivacaine 30 ml with dexamethasone 8 mg.administered via suprainguinal fascia iliaca block under ultrasound guidance.
Frequncy and Duration: Single administration intraoperativly before surgery.
Purpose:To evaluate the effect of adding dexamethasone to bupivacaine on duration and quality of postoperative analgesia in patients undergoing fracture hip surgery.
|
| Intervention |
Bupivacaine with Dexmedetomidine |
Intervention arm:Patient will recieve Injection bupivacaine with dexmedetomidine administered in suprainguinal fascia iliaca block.
Drug: Bupivacaine with Dexmedetomidine
Dosage and Route:0.25 percent bupivacaine 30 ml with dexmedetomidine 1 mcg per kg ,maximum of 50 mcgs administererd via suprainguinal fascia iliaca block under ultrasound guidance.
Frequency and Duration:single administration before surgery.
Purpose:To compare postoperative analgesic efficacy and duration of block with bupivacaine dexamethasone combination. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Patients undergoing hip surgery under spinal anaesthesia ASA Grade I and II |
|
| ExclusionCriteria |
| Details |
Patients not willing to participate in study with due consent
- Drug allergy to Dexmedatomidine
-Patients on B blocker,Heart block
-Patients with Psychiatric disorder
-Severe cardio-pulmonary disease
-severe hepatic,renal disease
-Neuromuscular disease
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| postoperative pain intensity and duration of analgesia with time of first rescue analgesic requirment. |
time of first rescue analgesic requirment. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| haemodynamic parameteres,sedation score,total amount of analgesic requirement in first 24 hours |
24 hours postoperative period |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
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)
|
01/01/2026 |
| 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 - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).
- What additional supporting information will be shared?
Response - Study Protocol
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 - Proposals should be directed to [drmeghasonavane@gmail.com].
- For how long will this data be available start date provided 01-06-2027 and end date provided 01-06-2030?
Response - Beginning 9 months and ending 36 months following article publication.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - nil
|
|
Brief Summary
|
Patients posted for proposed study will be diploid in the randomized pattern Total of 40 patients will be divided in 2 groups,20 patients in each group. Group DI: Dexamethasone group will receive 8 mg of Inj .Dexamethasone as adjuvant to Inj. Bupivacaine 0.25% Group DII: Dexmedetomidine group will receive 50 mcg of Inj.Dexmedetomidine as adjuvant to Inj.Bupivacaine 0.25%.
Study implications: This study will compare the efficacy of Dexamethasone and Dexmedetomidine as an adjuvant to bupivacaine in Suprainguinal fascia Iliaca block for post-operative analgesia in terms of its duration and Intensity. It also highlights its effect on hemodynamic stability. |