| CTRI Number |
CTRI/2025/08/093494 [Registered on: 22/08/2025] Trial Registered Prospectively |
| Last Modified On: |
22/08/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug Surgical/Anesthesia |
| Study Design |
Non-randomized, Multiple Arm Trial |
|
Public Title of Study
|
Regional anaesthesia with three different drug doses in sick and elderly patients with hip fracture |
|
Scientific Title of Study
|
Anaesthetic management of high risk orthopedic patients with combined sequential spinal epidural using three different doses of intrathecal ropivacaine |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Sathyasuba Meenakshi sundaram |
| Designation |
Associate Professor |
| Affiliation |
BIHER |
| Address |
#7, CLC Works road, Sree Balaji medical college and hospital, Chromepet, Chennai 600044. OR 10, Green star OT complex, 3rd floor, Dept. of Anaesthesia, SBMCH, Chennai 600044 Chennai TAMIL NADU 600044 India |
| Phone |
9791421124 |
| Fax |
|
| Email |
drsathyasuba@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Sathyasuba Meenakshi sundaram |
| Designation |
Associate Professor |
| Affiliation |
BIHER |
| Address |
#7, CLC Works road, Sree Balaji medical college and hospital, Chromepet, Chennai 600044. OR 10, Green star OT complex, 3rd floor, Dept. of Anaesthesia, SBMCH, Chennai 600044. Chennai TAMIL NADU 600044 India |
| Phone |
9791421124 |
| Fax |
|
| Email |
drsathyasuba@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Sathyasuba Meenakshi sundaram |
| Designation |
Associate Professor |
| Affiliation |
BIHER |
| Address |
#7, CLC Works road, Sree Balaji medical college and hospital, Chromepet, Chennai 600044. OR 10, Green star OT complex, 3rd floor, Dept. of Anaesthesia, SBMCH, Chennai 600044 Chennai TAMIL NADU 600044 India |
| Phone |
9791421124 |
| Fax |
|
| Email |
drsathyasuba@gmail.com |
|
|
Source of Monetary or Material Support
|
| SREE BALAJI MEDICAL COLLEGE AND HOSPITAL
CHROMPET, CHENNAI-44 |
|
|
Primary Sponsor
|
| Name |
NIL |
| Address |
NIL |
| 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 |
| Sathyasuba Meenakshi sundaram |
Sree Balaji medical college and hospital |
OR No.10, Green star OT complex, 3rd floor, Dept of Anaesthesia, Sree Balaji medical college and hospital, Chromepet, Chennai 600044
Chennai TAMIL NADU |
09791421124
drsathyasuba@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| IHEC-SBMCH |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M00-M99||Diseases of the musculoskeletal system and connective tissue, (2) ICD-10 Condition: M80||Osteoporosis with current pathological fracture, (3) ICD-10 Condition: M800||Age-related osteoporosis with current pathological fracture, (4) ICD-10 Condition: M800||Age-related osteoporosis with current pathological fracture, (5) ICD-10 Condition: O||Medical and Surgical, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Combined sequential spinal epidural anaesthesia |
Comparator 1 SAB with three and a half mg of ropivacaine heavy and epidural top up with half percent bupivacaine
|
| Comparator Agent |
Combined sequential spinal epidural anaesthesia |
Comparator 2 SAB with five mg of ropivacaine heavy and epidural top up with half percent bupivacaine |
| Comparator Agent |
Combined sequential spinal epidural anaesthesia |
Comparator 3 SAB with seven point five mg of ropivacaine heavy and epidural top up with half percent bupivacaine |
| Intervention |
SAB with different doses of spinal ropivacaine
|
SAB with three and a half mg five mg and seven and a half mg of ropivacaine |
|
|
Inclusion Criteria
|
| Age From |
65.00 Year(s) |
| Age To |
95.00 Year(s) |
| Gender |
Both |
| Details |
1.Patients with ASA III & above
2.Heart disease with systolic & diastolic dysfunction
3.IHD with no indication/unwilling for pre-procedure intervention
4.Patients of either sex above 75 yrs of age irrespective of other comorbidities
5.Patients of uncontrolled DM
6.Elective /emergency surgery
|
|
| ExclusionCriteria |
| Details |
1.Patients <65 yrs
2.Contraindication of CSEA/SAB
3.Not willing |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| The primary objective is to compare the hemodynamic stability measured in terms of fall in MAP 30% from baseline. |
Every 5 minutes, upto 30 minutes and then every 15 minutes till completion of surgery. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. Incidence of bradycardia
2. Time needed to achieve bromage 3 (complete motor paralysis)
3. Time needed to reach sensory T10
4. Volume of epidural bupivacaine to reach sensory T10
5. Surgeon satisfaction
6. Patient satisfaction
7. Adverse events if any
|
Whenever incidences are noticed from start of anaesthesia till completion of surgery |
|
|
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)
|
15/09/2025 |
| 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)
|
Closed to Recruitment of Participants |
| 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-identification.
- What additional supporting information will be shared?
Response - Study Protocol
- Who will be able to view these files?
Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.
- For what types of analyses will this data be available?
Response - For individual participant data meta-analysis.
- By what mechanism will data be made available?
Response - Proposals should be directed to [drsathyasuba@gmail.com].
- For how long will this data be available start date provided 20-09-2025 and end date provided 02-09-2026?
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
|
Patients will be observed in terms of 3 groups namely Group 1 SAB with three and a half mg of ropivacaine heavy and epidural top up with half percent bupivacaine till T10 level is achieved Group 2 SAB with five mg of ropivacaine heavy and epidural top up with half percent bupivacaine till T10 level is achieved Group 3 SAB with seven and a half mg of ropivacaine heavy and epidural top up with half percent bupivacaine till T10 level is achieved After 2 segment regression epidural top ups will be given with bupivacaine half percent either one third of the dose needed to achieve T10 level or 3 ml. The level of sensory block, modified Bromage motor scores MBS systolic blood pressure MAP and heart rate will be recorded for 30 min following anesthesia Peak sensory block height and MBS time for sensory regression to L1 and motor recovery to MBS 1 side effects and operator s satisfaction will be noted.Dural puncture will be performed at the L3 4 interspace with a 25 gauge Quincke tip spinal needle Next 0 5 percent hyperbaric ropivacaine will be given intrathecally in doses of 7 5 mg 11 25 mg and 15 mg in 3 groups namely groups 1 2 and 3 after the free flow of cerebrospinal fluid is observed The degree of sensory and motor block will be measured on the unoperated side of the limbs Surgery will be allowed to start as soon as the sensory block height reached the tenth thoracic dermatome T10 or 10 min had elapsed After 2 segment regression epidural top ups with bupivacaine 0 5 percent either 1/3 of the dose needed to achieve T10 level or 3 ml will be given,for the completion of surgery The orthopedic surgeons performing all the operations will grade the operator s satisfaction on a 5 point scale 5 very good 4 good 3 satisfactory 2 poor 1 very poor Similarly patient satisfaction will be noted down on a five point Likert scale Very satisfied Satisfied Neither satisfied nor dissatisfied Dissatisfied and Very dissatisfied from a scale of 5 to 1 |