| CTRI Number |
CTRI/2018/03/012534 [Registered on: 13/03/2018] Trial Registered Retrospectively |
| Last Modified On: |
|
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Cohort Study |
| Study Design |
Other |
|
Public Title of Study
|
Compare two doses of local anaesthetic drug given in spinal anesthesia for hip fracture repair in elderly females |
|
Scientific Title of Study
|
A prospective comparative study of the efficacy of standard dose bupivacaine versus low dose bupivacaine with fentanyl for hip arthroplasty in elderly females in a tertiary care hospital in south India . |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Deepa George |
| Designation |
Assistant Professor |
| Affiliation |
Govt T D Medical College , Alappuzha |
| Address |
Department of Anesthesiology
Govt T D Medical college,Alappuzha
Kerala
Alappuzha
KERALA
688005
India |
| Phone |
|
| Fax |
|
| Email |
drdeepagsaji@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Deepa George |
| Designation |
Assistant Professor |
| Affiliation |
Govt T D Medical College , Alappuzha |
| Address |
Department of Anesthesiology
Govt T D Medical college,Alappuzha
Kerala
Alappuzha
KERALA
688005
India |
| Phone |
|
| Fax |
|
| Email |
drdeepagsaji@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Deepa George |
| Designation |
Assistant Professor |
| Affiliation |
Govt T D Medical College , Alappuzha |
| Address |
Department of Anesthesiology
Govt T D Medical college,Alappuzha
Kerala
Alappuzha
KERALA
688005
India |
| Phone |
|
| Fax |
|
| Email |
drdeepagsaji@gmail.com |
|
|
Source of Monetary or Material Support
|
| State Board of Medical Research
TD Govt Medical College,Alappuzha |
|
|
Primary Sponsor
|
| Name |
Govt T D Medical College |
| Address |
Govt T D Medical College , Alappuzha
688005 |
| 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 |
| Dr Deepa George |
Department of Anesthesiology |
Govt TD Medical college
Alappuzha
688005
Alappuzha
KERALA |
9495918994
drdeepagsaji@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Commitee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
ASA 1-4 female patients for hip arthroplasty under spinal anesthesia , |
|
|
Intervention / Comparator Agent
|
|
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Inclusion Criteria
|
| Age From |
65.00 Year(s) |
| Age To |
90.00 Year(s) |
| Gender |
Female |
| Details |
Height between 145 -155 cm
Patients who have been given minimal sedation or analgesics for positioning |
|
| ExclusionCriteria |
| Details |
Patients who were given bolus dose of propofol for sedation and
Patients who were given peripheral nerve blocks to aid in positioning |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Acceptable duration of analgesia for the procedure |
Time from start to end of surgery |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| maximum level of sensory block ,time to attain maximum level of sensory block,incidence of side effects like hypotension and bradycardia |
Sensory level will be checked every min for 10 min.Blood pressure and heart rate will be checked every 5 min |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
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)
|
14/11/2017 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
14/11/2017 |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="0"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Closed to Recruitment of Participants |
|
Publication Details
|
|
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Elderly patients particularly females are very prone for hip fractures.Surgical repair of hip fracture is commonly done under spinal anesthesia .Bradycardia and hypotension are the main side effects of spinal anesthesia and these effects may be exaggerated in the elderly because of their multiple comorbid conditions.The incidence of side effects can be reduced by decreasing the dose of local anaesthetic but that may not provide an acceptable duration of analgesia. Hence opioids like fentanyl can be added added since it has a synergestic effect with local anaesthetics in increasing the duration of analgesia with excellent hemodynamic stability..This study compares 2 different doses of bupivacaine with fentanyl for hip arthroplasty under spinal anesthesia |