| CTRI Number |
CTRI/2020/05/025207 [Registered on: 15/05/2020] Trial Registered Prospectively |
| Last Modified On: |
01/06/2021 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A Randomized Control Trial Comparing Pain Profiles After Combined Peripheral Nerve Blocks Versus Spinal Anaesthesia For Proximal Femoral Nailing |
|
Scientific Title of Study
|
A randomised controlled trial comparing pain profiles after Combined peripheral nerve block versus spinal anaesthesia for proximal femoral nailing |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Temy Manuel |
| Designation |
Post Graduate |
| Affiliation |
Jubilee Mission Medical College Hospital and Research Institute East fort Thrissur |
| Address |
Department of Anaesthesia
Jubilee Mission Medical College Hospital and Research Institute East fort
Thrissur
Kerala
India
Thrissur
KERALA
680005
India |
| Phone |
9048728065 |
| Fax |
|
| Email |
drtemymanuel@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Usha Shenoy |
| Designation |
Additional Professor |
| Affiliation |
Jubilee Mission Medical College Hospital and Research Institute East fort Thrissur |
| Address |
Department of Anaesthesia
Jubilee Mission Medical College Hospital and Research Institute East fort
Thrissur
Kerala
India
Thrissur
KERALA
680005
India |
| Phone |
9446575724 |
| Fax |
|
| Email |
rssuss@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Usha Shenoy |
| Designation |
Additional Professor |
| Affiliation |
Jubilee Mission Medical College Hospital and Research Institute East fort Thrissur |
| Address |
Department of Anaesthesia
Jubilee Mission Medical College Hospital and Research Institute East fort
Thrissur
Kerala
India
Thrissur
KERALA
680005
India |
| Phone |
9446575724 |
| Fax |
|
| Email |
rssuss@gmail.com |
|
|
Source of Monetary or Material Support
|
| Jubilee mission medical college hospital and research institute,East fort , Thrissur Kerala India 680005 |
|
|
Primary Sponsor
|
| Name |
Jubilee Mission Medical College Hospital and Research Institute |
| Address |
East fort
Thrissur |
| 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 |
| Usha Shenoy |
Jubilee Mission Medical College Hospital and Research Institute |
Department of Anaesthesia
Thrissur
KERALA |
9446575724
rssuss@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 2 |
| Name of Committee |
Approval Status |
| Institutional ethics committee Jubilee Mission Medical College Thrissur |
Approved |
| Institutional ethics committee, Jubilee Mission Medical College Thrissur |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M848||Other disorders of continuity of bone, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Peripheral nerve blocks |
Peripheral nerve blocks are used for proximal femoral nailing |
| Comparator Agent |
Spinal Anaesthesia |
Spinal Anaesthesia is used for proximal femoral nailing |
|
|
Inclusion Criteria
|
| Age From |
60.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
ASA status I to III
60 to 100 years of age
Weight 35 TO 70 Kg |
|
| ExclusionCriteria |
| Details |
Contraindication to regional anaesthesia
Preference for regional Anaesthesia
Neurological disorder affecting the lower extremities
Lack of competence to consent |
|
|
Method of Generating Random Sequence
|
Permuted block randomization, fixed |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Time of request for first rescue analgesia after the intervention is calculated from the time onset of sensory block
Total dose of rescue analgesia in first 24 hours |
18 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Post operative quality of recovery scale at 24 hours -Based on Quality of Recovery Scale QoR 15 Scores
Need for ICU admission
Length of hospital stay-Number of days |
18 Months |
|
|
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 1 |
|
Date of First Enrollment (India)
|
17/05/2020 |
| 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="1"
Months="6"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
Nil |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
Brief Summary
Modification(s)
|
This study is designed to compare the post operative pain and peri operative outcomes in patients undergoing PFN with combined peripheral nerve blocks versus spinal anaesthesia. |