| CTRI Number |
CTRI/2026/02/103968 [Registered on: 16/02/2026] Trial Registered Prospectively |
| Last Modified On: |
13/02/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Follow Up Study |
| Study Design |
Non-randomized, Active Controlled Trial |
|
Public Title of Study
|
Comparing Two Types of Spinal Anaesthesia in Patients Undergoing Knee Replacement: Effects on Urination and Recovery Time After Surgery |
|
Scientific Title of Study
|
Effect of Bupivacaine Versus Bupivacaine Fentanyl Spinal Anaesthesia in Total Knee Replacement on Postoperative Urinary Function and Post Anaesthetic Care Unit Discharge Times |
| Trial Acronym |
nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Bhagyashree M Sangashetty |
| Designation |
Post graduate |
| Affiliation |
Kasturba medical college |
| Address |
Department of Anaesthesiology Kasturba Medical College Light
House hill road Mangalore
Dakshina Kannada
KARNATAKA
575001
India |
| Phone |
9482016898 |
| Fax |
|
| Email |
bmsangashetty@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr. Sumesh T Rao |
| Designation |
Professor & Head |
| Affiliation |
Kasturba Medical College |
| Address |
Department of Anaesthesiology,
Kasturba Medical College, Mangalore
Office of Medical Education Unit, Kasturba Medical College, Light House Hill Road, Mangalore-575001, Karnataka, India
Dakshina Kannada
KARNATAKA
575001
India |
| Phone |
9449167895 |
| Fax |
|
| Email |
sumesh.rao@manipal.edu |
|
Details of Contact Person
Public Query
|
| Name |
Bhagyashree M Sangashetty |
| Designation |
Post graduate |
| Affiliation |
Kasturba medical college |
| Address |
Department of Anaesthesiology Kasturba Medical College Light
House hill road Mangalore
Dakshina Kannada
KARNATAKA
575001
India |
| Phone |
9482016898 |
| Fax |
|
| Email |
bmsangashetty@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Kasturba Medical college |
| Address |
Office of Medical Education Unit, Kasturba Medical College, Light House Hill Road, Mangalore-575001, Karnataka, India |
| 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 |
| Javeed |
Kasturba Medical College, Mangalore |
Department of Anaesthesiology
Kasturba Medical College, Mangalore
Dakshina Kannada
KARNATAKA |
9482016898
sangashettycm@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Kasturba Medical college |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: Z539||Procedure and treatment not carried out, unspecified reason, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Bupivacaine |
Patients receiving intrathecal hyperbaric Bupivacaine for spinal anaesthesia as part of routine institutional practice for total knee replacement surgery. The choice of anaesthetic technique is made by the treating anaesthesiologist. No randomization or allocation is performed as part of the study. |
| Comparator Agent |
Bupivacaine with Fentanyl |
Patients receiving intrathecal hyperbaric Bupivacaine combined with Fentanyl for spinal anaesthesia as part of routine institutional practice for total knee replacement surgery. The choice of anaesthetic technique is determined by the treating anaesthesiologist. The investigator only observes and records outcomes. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
85.00 Year(s) |
| Gender |
Both |
| Details |
1. Patients undergoing unilateral total knee replacement surgery under spinal anaesthesia
2. Age range harmonized to 18 to 85 years |
|
| ExclusionCriteria |
| Details |
1. Patients undergoing bilateral total knee replacement surgery
2. American Society of Anesthesiologists grade greater than three
3. Unstable or poorly controlled diseases such as end stage renal disease, coronary artery disease with prior percutaneous coronary intervention
4. History of deep vein thrombosis or pulmonary embolism
5. Severe anxiety disorders or cognitive impairments
6. Coagulopathy |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Time from spinal injection to first spontaneous voiding post-surgery. |
6 to 8 hours post-surgery |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Discharge from PACU & Postoperative analgesia |
4 to 6 hours post-surgery |
|
|
Target Sample Size
|
Total Sample Size="126"
Sample Size from India="126"
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)
|
24/02/2026 |
| 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="2"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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 - NO
|
|
Brief Summary
|
Total knee replacement surgery is a common procedure aimed at alleviating pain and restoring function in patients with severe knee arthritis or injuries. Effective pain management during surgery and after surgery is crucial for patients recovery and patient statisfaction.spinal anaesthesia is freqently used in these surgeries due to its ability to provide profound analgesia and muscle relaxation |