| CTRI Number |
CTRI/2014/06/004708 [Registered on: 26/06/2014] Trial Registered Retrospectively |
| Last Modified On: |
26/06/2014 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Pain relief comparing combination of Dexmedetomidine Plus Bupivacaine And Ketamine Plus Bupivacaine for hip fracture patients |
|
Scientific Title of Study
|
A Prospective randomized control trial to compare the analgesic effect of epidural Dexmedetomidine plus Bupivacaine and epidural Ketamine plus Bupivacaine in patients with hip factures |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Nilesh Balu Sonawane |
| Designation |
MBBS DNB Anaesthesia Diploma in Anaesthesia |
| Affiliation |
Ganga Hospital |
| Address |
Plot No 25 Bilvapatra Torna nagar Uday colony Nashik
Nashik
MAHARASHTRA
422008
India |
| Phone |
9619597014 |
| Fax |
|
| Email |
sonawanenilesh805@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Nilesh Balu Sonawane |
| Designation |
MBBS DNB Anaesthesia Diploma in Anaesthesia |
| Affiliation |
Ganga Hospital |
| Address |
Plot No 25 Bilvapatra Torna nagar Uday colony Nashik
Nashik
MAHARASHTRA
422008
India |
| Phone |
9619597014 |
| Fax |
|
| Email |
sonawanenilesh805@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Nilesh Balu Sonawane |
| Designation |
MBBS DNB Anaesthesia Diploma in Anaesthesia |
| Affiliation |
Ganga Hospital |
| Address |
Plot No 25 Bilvapatra Torna nagar Uday colony Nashik
Nashik
MAHARASHTRA
422008
India |
| Phone |
9619597014 |
| Fax |
|
| Email |
sonawanenilesh805@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Ganga Hospital |
| Address |
313 mettupalayam road sai baba colony Coimbatore 641043
Tamil nadu |
| Type of Sponsor |
Research institution and hospital |
|
|
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 J Balavenkatasubramanian |
Orthopaedic and trauma operation theatre 5th floor |
Ganga Hospital
313 mettupalayam road
sai baba colony
Coimbatore
TAMIL NADU |
9345645757
drbalavenkat@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Review Board |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
Patients having hip fractures, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Dexmedetomidine |
Initially dexmedetomidine bolus 1 microgram per kg diluted in 5ml distilled water given epidurally bolus at start of surgery. Then after 1hour of bolus dose 250ml elastomeric epidural infusion pump to be connected containing 0.125 percent bupivacaine plus 1 microgram per ml dexmedetomidine at 5ml per hour for 48 hours |
| Comparator Agent |
Ketamine |
Initially preservative free ketamine bolus 0.5milligram per kg diluted in 5ml distilled water and given epidural bolus at start of surgery. Then after 1hour of bolus dose 250 ml elastomeric epidural infusion pump to be connected containing 0.125 percent bupivacaine plus 0.5 milligram per ml preservative free ketamine at 5ml per hour for 48 hours |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
75.00 Year(s) |
| Gender |
Both |
| Details |
American Society Anaesthesia (ASA) physical status
I and II patients, Both sex, Hip fracture surgeries, Elective Surgeries
|
|
| ExclusionCriteria |
| Details |
Allergy to the drug being used, Refusal of patient to regional anaesthesia,Bleeding diasthesis, With uncontrolled hypertension, Heart rate <60 beats/minute
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Centralized |
|
Blinding/Masking
|
Participant, Investigator and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| VAS score less than 3 at operative site |
48 hours |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Motor blockade Swnsory blockade
Side effects |
48 hours |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
Final Enrollment numbers achieved (Total)= ""
Final Enrollment numbers achieved (India)="" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
01/09/2012 |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="9"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
|
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
A prospective randomized double blind controlled trial including 60 ASA I & II patients between age 18 – 75 yrs for elective hip fracture surgery divided into 2 groups Group K Ketamine plus Bupivacaine and Group D Dexmedetomidine plus Bupivacaine. The study compares the effects of dexmedetomidine plus bupivacaine and preservative free ketamine plus bupivacaine in hip fracture surgeries in postoperative period for 48 hrs with continuous epidural infusion and thus concluding which drug combination produces better analgesia with minimal haemodynamic alterations. |