| CTRI Number |
CTRI/2025/12/098253 [Registered on: 01/12/2025] Trial Registered Prospectively |
| Last Modified On: |
28/11/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Which spinal anesthesia dose works better? A comparison of two strengths of isobaric ropivacaine with morphine in lower limb surgeries |
|
Scientific Title of Study
|
A comparison of intrathecal 0.5% isobaric ropivacaine and 0.75% isobaric ropivacaine with morphine as adjuvant in lower limb surgeries |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
DR Arun Kumar B |
| Designation |
Professor |
| Affiliation |
Vinayaka missions Kirupanandha Variyar Medical College , Salem - 636308 |
| Address |
Room no 15,
Vinayaka missions Kirupanandha variyar medical college and Hospitals,
Salem 636308
Tamil Nadu
India
Salem
TAMIL NADU
636308
India |
| Phone |
9840623673 |
| Fax |
|
| Email |
cruise2010.mmc@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DR Arun Kumar B |
| Designation |
Professor |
| Affiliation |
Vinayaka missions Kirupanandha Variyar Medical College , Salem - 636308 |
| Address |
Room no 15,
Vinayaka missions Kirupanandha variyar medical college and Hospitals,
Salem 636308
Tamil Nadu
India
TAMIL NADU
636308
India |
| Phone |
9840623673 |
| Fax |
|
| Email |
cruise2010.mmc@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Shri Harini K |
| Designation |
Postgraduate |
| Affiliation |
Vinayaka missions Kirupanandha Variyar Medical College , Salem - 636308 |
| Address |
Room no 15,
Vinayaka missions Kirupanandha variyar medical college and Hospitals,
Salem 636308
Tamil Nadu
India
Salem
TAMIL NADU
636308
India |
| Phone |
9629574742 |
| Fax |
|
| Email |
harini.kans@gmail.com |
|
|
Source of Monetary or Material Support
|
| Room No 15,
Department of Anesthesia,
Vinayaka Missions Kirupanandha Variyar Medical College and Hospitals,Chinnaseeragapadi Salem-636308, Tamil Nadu
India |
|
|
Primary Sponsor
|
| Name |
Vinayaka missions Kirupanandha Variyar Medical College and Hospitals |
| Address |
Room no 15
Vinayaka Missions Kirupanandha Variyar Medical College and Hospitals
Salem 636308
Tamil Nadu
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 |
| Dr Shri Harini K |
Vinayaka missions Kirupanandha Variyar Medical College , Salem |
Room no 15,
Department of Anesthesia,
Vinayaka missions Kirupanandha Variyar Medical College and Hospitals,
Chinnaseeragapadi,
Salem-636308,Tamil Nadu,
India
Salem
TAMIL NADU |
9629574742
harini.kans@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| UNIVERSITY ETHICS COMMITTEE VMRF-DU |
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 |
Intrathecal 0.5% isobaric ropivacaine with morphine in lower limb surgeries |
Name of Intervention:
Intrathecal 0.5% isobaric ropivacaine with morphine
Type of agent: Drug
Route of administration: Intrathecal (spinal)
To compare with higher concentration (0.75%) for differences in block onset, level, duration, and analgesic profile. |
| Intervention |
Intrathecal 0.75% isobaric ropivacaine with morphine in lower limb surgeries
|
Name of intervention: Intrathecal 0.75% isobaric ropivacaine with morphine in lower limb surgeries
Type of intervention: Drug
Route of administration: Intrathecal (spinal)
To evaluate onset, level, and duration of sensory and motor block, and duration of postoperative analgesia. |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1.Patient giving valid informed consent
2.ASA grade 1 and 2
3.Age between 20 to 60 years
4.Elective lower limb surgeries |
|
| ExclusionCriteria |
| Details |
1.Patient refusal
2.ASA grade 3 and 4
3.Age less than 20 years and more than 60 years
4.Emergency surgeries
5.IHD , Angina, arrythmias,MI
6.Metabolic disorders, neurological ,cardiovascular , congenital diseases
7.Patients allergic to local anesthetic drugs |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To determine the time of onset of sensory blockade and motor blockade after intrathecal injection of the drug |
Defined as time (minutes) from intrathecal injection to loss of pinprick sensation at the T10 dermatome; assessed every 1–2 minutes after injection until T10 achieved and inability to move the lower limbs |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To determine the postoperative hemodynamic changes and side effect such as nausea, vomiting , shivering , hypotension , bradycardia and respiratory depression |
From immediate postoperative period until 24 hours |
|
|
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 4 |
|
Date of First Enrollment (India)
|
20/12/2025 |
| 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="0"
Months="6"
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
|
This study aims to compare the clinical effectiveness and safety of two concentrations of intrathecal isobaric ropivacaine—0.5% and 0.75%—when used along with morphine as an adjuvant for spinal anesthesia in patients undergoing lower limb surgeries. Participants will be randomly allocated into two groups: one receiving 0.5% isobaric ropivacaine with morphine and the other receiving 0.75% isobaric ropivacaine with morphine.
The study will evaluate the onset and duration of sensory and motor block, quality of intraoperative anesthesia, postoperative analgesia duration, hemodynamic stability, and adverse effects. The objective is to determine which concentration provides better intraoperative conditions and longer, safer postoperative pain relief without increasing side effects. This comparison will help identify the optimal intrathecal dose of isobaric ropivacaine with morphine for lower limb surgeries. |