| CTRI Number |
CTRI/2026/01/100975 [Registered on: 13/01/2026] Trial Registered Prospectively |
| Last Modified On: |
12/01/2026 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
A study to evaluate spinal anaesthesia for planned lower limb surgeries |
|
Scientific Title of Study
|
A Dose Response Study To Evaluate The Minimal Effective Dose Of 0.5% Isobaric Levo Bupivacaine In Continuous Spinal Anaesthesia For Elective 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.Mitali Khobragade |
| Designation |
Assistant Professor |
| Affiliation |
PCMC PGI YCM Hospital, Pimpri , Pune |
| Address |
PCMC PGI YCM Hospital, Pimpri, Pune
Pune
MAHARASHTRA
411018
India |
| Phone |
8669165752 |
| Fax |
|
| Email |
khobragademitali6@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr.Mitali Khobragade |
| Designation |
Assistant Professor |
| Affiliation |
PCMC PGI YCM Hospital, Pimpri, Pune |
| Address |
PCMC PGI YCM Hospital, Pimpri, Pune
Pune
MAHARASHTRA
411018
India |
| Phone |
8669165752 |
| Fax |
|
| Email |
khobragademitali6@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr.Mitali Khobragade |
| Designation |
Assistant Professor |
| Affiliation |
PCMC PGI YCM Hospital, Pimpri, Pune |
| Address |
PCMC PGI YCM Hospital,Pimpri, Pune
Pune
MAHARASHTRA
411018
India |
| Phone |
8669165752 |
| Fax |
|
| Email |
khobragademitali6@gmail.com |
|
|
Source of Monetary or Material Support
|
| PCMC PGI YCM Hospital
Sant Tukaram Nagar, Pimpri
Pune 411018
Maharashtra
India |
|
|
Primary Sponsor
|
| Name |
PCMC PGI YCM Hospital |
| Address |
PCMC PGI YCM Hospital
Sant Tukaram Nagar, Pimpri
Pune 411018
Maharashtra
India |
| 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 |
| Dr Mitali Khobragade |
PCMC PGI YCM Hospital, Pimpri |
Department of Anaesthesiology,
Floor No. 1,Dhanvantari Main OT Complex,PCMC PGI YCM Hospital,
Pimpri,
Pune 411018
Maharashtra,India
Pune
MAHARASHTRA |
8669165752
khobragademitali6@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| ETHICS COMMITTEE PCMCS POST GRADUATE INSTITUTE YASHWANTRAO CHAVAN MEMORIAL HOSPITAL |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M259||Joint disorder, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Levobupivacaine |
Patients undergoing elective intertrochanteric femur surgery will receive continuous spinal anaesthesia using 0.5% isobaric levobupivacaine administered intrathecally through a spinal catheter.The initial dose and subsequent incremental doses will bedetermined as per the study protocol to identify the minimal effective dose required to achieve adequate surgical anaesthesia.Hemodynamic parameters,sensory and motor block characteristics and adverse events will be monitored intraoperatively. |
| Comparator Agent |
NOT APPLICABLE |
NOT APPLICABLE |
|
|
Inclusion Criteria
|
| Age From |
25.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
. ASA I-II
. Elective intertrochanteric femur surgery
. Height 150cm-180cm |
|
| ExclusionCriteria |
| Details |
. Allergy to local anaesthetics
. Coagulopathy or anticoagulant therapy
. Infection at puncture site |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Minimal effective dose of 0.5% isobaric levobupivacaine required to achieve adequate sensory block for surgery during continuous spinal anaesthesia in patients undergoing lower limb surgeries |
From initiation of intrathecal drug administration until achievement of adequate sensory block intraoperatively for surgery |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
.To assess hemodynamic parameters
|
.Baseline and intraoperatively at regular intervals until completion of surgery. |
| .Onset and duration of sensory and motor block |
From intrathecal drug administration until achievement of adequate sensory block and intraoperatively
|
| .Total top ups of injection 0.5% Isobaric Levobupivacaine required |
.From initiation of intrathecal drug administration until the end of surgery |
| .Adverse effects of injection 0.5% Isobaric Levobupivacaine and injection Fentanyl |
.Intraoperative period and immediate postoperative period. |
|
|
Target Sample Size
|
Total Sample Size="67"
Sample Size from India="67"
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)
|
10/02/2026 |
| 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="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 - YES
- What data in particular will be shared?
Response - All of the individual participant data collected during the trial, after de-identiļ¬cation.
- What additional supporting information will be shared?
Response - Study Protocol
Response - Statistical Analysis Plan
Response - Informed Consent Form
Response - Clinical Study Report
Response - Analytic Code
- Who will be able to view these files?
Response - Researchers who provide a methodologically sound proposal.
- For what types of analyses will this data be available?
Response - To achieve aims in the approved proposal.
- By what mechanism will data be made available?
Response - Proposals should be directed to [khobragademitali6@gmail.com].
- For how long will this data be available start date provided 01-11-2026 and end date provided 01-11-2031?
Response - Beginning 3 months and ending 5 years following article publication.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
|
|
Brief Summary
|
This is a prospective single centre interventional dose response study designed to evaluate the minimal effective dose of 0.5 percent isobaric levobupivacaine for continuous spinal anaesthesia in patients undergoing elective intertrochanteric femur surgery.Adult patients scheduled for surgery under continuous spinal anaesthesia will be enrolled.0.5 percent Isobaric Levobupivacaine will be administered intrathecally through a spinal catheter in incremental doses as per the study protocol. The primary objective is to determine the minimal effective dose required to achieve adequate surgical anaesthesia. Secondary objectives include assessment of hemodynamic changes and onset and duration of sensory and motor block and total number of top ups required and incidence of adverse effects during the intraoperative and immediate postoperative period. |