| CTRI Number |
CTRI/2025/08/093360 [Registered on: 20/08/2025] Trial Registered Prospectively |
| Last Modified On: |
16/08/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A study to compare the effect of intrathecal 0.75 (H) Ropivacaine and 0.5 %(H) Bupivacaine in orthopaedic patients undergoing lower limb surgeries under spinal anesthesia |
|
Scientific Title of Study
|
A Prospective double blind randomised study to compare the effect of intrathecal 0.75 (H) Ropivacaine and 0.5 %(H) Bupivacaine in orthopaedic patients undergoing lower limb surgeries under subarachnoid block |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Neetiksha |
| Designation |
Senior Resident |
| Affiliation |
Pt JLNGMC ,chamba, HP |
| Address |
Deptt of anesthesia
Pt JLNGMC chamba HP
Chamba
HIMACHAL PRADESH
176310
India |
| Phone |
9816200698 |
| Fax |
|
| Email |
neetikshasingh@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Neetiksha |
| Designation |
Senior Resident |
| Affiliation |
Pt JLNGMC ,chamba, HP |
| Address |
Deptt of anesthesia
Pt JLNGMC chamba HP
Chamba
HIMACHAL PRADESH
176310
India |
| Phone |
9816200698 |
| Fax |
|
| Email |
neetikshasingh@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Neetiksha |
| Designation |
Senior Resident |
| Affiliation |
Pt JLNGMC ,chamba, HP |
| Address |
Deptt of anesthesia
Pt JLNGMC chamba HP
Chamba
HIMACHAL PRADESH
176310
India |
| Phone |
9816200698 |
| Fax |
|
| Email |
neetikshasingh@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Neetiksha |
| Address |
Pt JLNGMC Chamba ,HP |
| 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 |
| Neetiksha |
Operation theatre, department of anaesthesia , Pt JLNGMC Chamba |
Department of anesthesia,
Pt JLNGMC chamba
Chamba
HIMACHAL PRADESH |
9816200698
neetikshasingh@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethics committee, GMC , chamba |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O||Medical and Surgical, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
0.5% H Bupivacaine |
Subarachnoid block using fixed dose of 0.5% H Bupivacine |
| Intervention |
0.75% H Ropivacaine |
Subarachnoid block using fixed dose 0.75 %H Ropivacaine |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Patient for orthopaedic lower limb surgery
ASAI and II
BMI less than 30kg per metre sq
Height in between 150 to 180 cm |
|
| ExclusionCriteria |
| Details |
Patient not giving cons
ASA III or more
Contraindication for SAB
SAB converted into GA |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Onset and duration of sensory block
Onset and duration of motor block
Two segments dermatome regression time for sensory blockade |
1 year |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Time of first requirement of rescue analgesia
Haemodynamic parameters bp and hr
Adverse effects hypotension, bradycardia, respiratory depression, shivering |
1 year |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
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)
|
30/08/2025 |
| 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
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Study to compare the clinical efficacy , safety, hemodynamic effects and complications of hyperbaric fixed intrathecal dose of 0.5 % H bupivacaine and 0.75 % H ropivacaine in patients undergoing lower limb orthopaedic surgies |