| CTRI Number |
CTRI/2020/05/025164 [Registered on: 13/05/2020] Trial Registered Prospectively |
| Last Modified On: |
28/04/2020 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Follow Up Study |
| Study Design |
Non-randomized, Multiple Arm Trial |
|
Public Title of Study
|
To compare the proportion of patients experiencing post operative urinary retention between patients receiving unilateral or bilateral spinal anaesthesia for lower limb orthopaedic surgeries. |
|
Scientific Title of Study
|
Post-operative urinary retention in patients undergoing orthopaedic procedures: unilateral vs bilateral spinal anaesthesia |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Sharika Sriramanan |
| Designation |
Junior Resident |
| Affiliation |
Kasturba Medical College and Hospitals, Mangalore |
| Address |
Department of Anaesthesiology, Kasturba Medical College, Lighthouse Hill Road, Mangalore, Dakshina Kannada, Karnataka - 575001
Dakshina Kannada
KARNATAKA
575001
India |
| Phone |
7760413236 |
| Fax |
|
| Email |
sharika.sriramanan@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Padmanabha Kaimar |
| Designation |
Associate Professor |
| Affiliation |
Kasturba Medical College, Mangalore |
| Address |
Department of Anaesthesiology, Kasturba Medical College, Lighthouse Hill Road, Mangalore, Dakshina Kannada, Karnataka - 575001
Dakshina Kannada
KARNATAKA
575001
India |
| Phone |
9880094661 |
| Fax |
|
| Email |
padmanabhakaimar@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Padmanabha Kaimar |
| Designation |
Associate Professor |
| Affiliation |
Kasturba Medical College, Mangalore |
| Address |
Department of Anaesthesiology, Kasturba Medical College, Lighthouse Hill Road, Mangalore, Dakshina Kannada, Karnataka - 575001
Dakshina Kannada
KARNATAKA
575001
India |
| Phone |
9880094661 |
| Fax |
|
| Email |
padmanabhakaimar@gmail.com |
|
|
Source of Monetary or Material Support
|
| Manipal Institute of Health Education |
|
|
Primary Sponsor
|
| Name |
Dr Sharika Sriramanan |
| Address |
Department of Anaesthesiology, Kasturba Medical College, Lighthouse Hill Road, Mangalore, Dakshina Kannada, Karnataka - 575001 |
| 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 Sharika Sriramanan |
Kasturba Medical College and Hospitals |
Department of Anaesthesiology, Kasturba Medical College, Mangalore, Dakshina Kannada, Karnataka - 575003
Dakshina Kannada
KARNATAKA |
7760413236
sharika.sriramanan@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, Kasturba Medical College, Mangalore |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: N998||Other intraoperative and postprocedural complications and disorders of genitourinary system, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
1. Bilateral spinal anaesthesia
2. Unilateral spinal anaesthesia |
Comparison of proportion of post-operative urinary retention in patients undergoing orthopaedic procedures under unilateral and bilateral spinal anaesthesia. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1. ASA- 1, ASA- 2 patients
2. Patients with no contraindications for spinal or general anaesthesia.
3. Patients undergoing lower limb orthopaedic procedures involving knee and/or ankle joint. |
|
| ExclusionCriteria |
| Details |
1. Patient refusal.
2. Heart block, dysrhythmia, uncontrolled hypertension or any other severe systemic disease.
3. ASA-3 and ASA- 4 patients.
4. Psychiatric illnesses that would interfere with the perception and assessment of post-operative urinary assessment.
5. Patients with pre-existing indwelling catheters. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
Assessment of proportion of post-operative urinary retention in patients undergoing procedures under unilateral and bilateral spinal anaesthesia.
Time taken to first void after the procedure/anaesthesia. |
Assessment of proportion of post-operative urinary retention in patients undergoing procedures under unilateral and bilateral spinal anaesthesia upto 12 hours after the procedure
Time taken to first void after the procedure/anaesthesia upto 12 hours after the procedure. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Assessment of need for catheterisation in patients undergoing orthopaedic procedures: unilateral vs bilateral spinal anaesthesia |
Assessment of need for catheterisation in patients undergoing orthopaedic procedures: unilateral vs bilateral spinal anaesthesia
Assessment of need for catheterisation in patients undergoing orthopaedic procedures: unilateral vs bilateral spinal anaesthesia |
|
|
Target Sample Size
|
Total Sample Size="84"
Sample Size from India="84"
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)
|
01/06/2020 |
| 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="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
Nil |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
1. To study the proportion of post-operative urinary retention in patients undergoing orthopaedic procedures under unilateral and bilateral spinal anaesthesia and to compare the same.
2. To measure the time taken for the patient to first void after the procedure/anaesthesia in the two groups.
3. To evaluate the need for catheterisation in the two groups. |