| CTRI Number |
CTRI/2025/02/081378 [Registered on: 27/02/2025] Trial Registered Prospectively |
| Last Modified On: |
16/02/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Medical Device
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Evaluating the Best Approach for Spinal Anesthesia in Elderly Patients with Lower Limb Injuries |
|
Scientific Title of Study
|
Comparison of classical midline approach versus modified paramedian approach in spinal Anaesthesia for lower limb orthopedic surgeries in elderly patients |
| 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 Gopikrishnan |
| Designation |
Post graduate |
| Affiliation |
shri sathya sai medical college and research institute |
| Address |
Department of anaesthesia ,shri sathya sai medical college and research institute,Thiruporur ,Guduvancherry main road,chengalpattu taluk,kancheepuram,tamilnadu
Kancheepuram
TAMIL NADU
603108
India |
| Phone |
09677511171 |
| Fax |
|
| Email |
gopi_g19@yahoo.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Jagan |
| Designation |
Associate Professor |
| Affiliation |
shri sathya sai medical college and research institute |
| Address |
Department of anaesthesia ,shri sathya sai medical college and research institute,Thiruporur ,Guduvancherry main road,chengalpattu taluk,kancheepuram,tamilnadu
Kancheepuram
TAMIL NADU
603108
India |
| Phone |
9940623333 |
| Fax |
|
| Email |
drjagangovindasamy@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Gopikrishnan |
| Designation |
Post graduate |
| Affiliation |
shri sathya sai medical college and research institute |
| Address |
Department of anaesthesia ,shri sathya sai medical college and research institute,Thiruporur ,Guduvancherry main road,chengalpattu taluk,kancheepuram,tamilnadu
Kancheepuram
TAMIL NADU
603108
India |
| Phone |
09677511171 |
| Fax |
|
| Email |
gopi_g19@yahoo.in |
|
|
Source of Monetary or Material Support
|
| shri sathya sai medical college and research institute,Thiruporur,Guduvancherry main road, chengalpattu taluk,kancheepuram district,tamilnadu 603108 |
|
|
Primary Sponsor
|
| Name |
Dr Gopikrishnan |
| Address |
Department of Anaesthesia,Shri sathya sai medical college and research institute,thiruporur,guduvancherry main road,chengalpattu taluk,kancheepuram,Tamilnadu,603108 |
| Type of Sponsor |
Other [Self] |
|
|
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 Gopikrishnan |
shri sathya sai medical college and research instiute |
Department of anesthesia,2nd floor anaesthesia OT complex.Thiruporur,Guduvancherry main road chengalpattu taluk,ammapettai,kancheepuram District,Tamilnadu.603108
Kancheepuram
TAMIL NADU |
09677511171
gopi_g19@yahoo.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| shri sathya sai medical college and research institute |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M95-M95||Other disorders of the musculoskeletal system and connective tissue, (2) ICD-10 Condition: 4||Measurement and Monitoring, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Group A: Patients who are receiving classical midline neuraxial block |
While using the classical midline approach at the desired level (midline) the needle passes through skin, subcutaneous tissue, supraspinous ligament, interspinous ligament, ligamentum flavum, epidural space, duramater, arachnoid mater and finally subarachnoid space |
| Intervention |
Group B: Patients who are receiving modified paramedian neuraxial block |
In modified paramedian technique, needle is inserted 0.5cm inferolateral to midline and and feels only the resistance of ligamentum flavum and pierces the dura evading the supraspinous and interspinous ligaments and enters the interlaminar space more easily. |
|
|
Inclusion Criteria
|
| Age From |
65.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
Patient posted for elective lower limb orthopedic surgeries under ASA I and II with BMI 18.5-29.9 (normal and overweight category).
|
|
| ExclusionCriteria |
| Details |
Emergency lower limb orthopedic surgeries.
Refusal to participation.
Allergic to local anaesthetic and adjuvants.
Contraindications to Spinal anaesthesia
Local infections.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| success rates and lesser number of attempts |
30minutes |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To assess the occurrence of side effects such as headache, nausea, vomiting within 24 hours of operation and Visual analogue scale for low back pain. |
24 hours |
|
|
Target Sample Size
|
Total Sample Size="80"
Sample Size from India="80"
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)
|
28/03/2025 |
| 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="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
|
After approval from ethical committee, patients posted for lower limb orthopedic surgeries in geriatric age from the Department of Orthopaedics surgery will be taken for study after obtaining written and informed consent, anaesthetic checkup will be done on those patients who fit into the inclusion criteria will be analyzed thoroughly and taken up for the study. Randomization will be done by computer generated card of patient and allocated into two equal groups: Group A and Group B Group A: Patients who are receiving classical midline neuraxial block (n=40) Group B: Patients who are receiving modified paramedian neuraxial block (n=40) During the procedure, number of attempts, time taken to perform the spinal anaesthesia will be recorded. After the procedure, standard monitoring of ECG, pulse oximetry and non-invasive blood pressure for 30minutes. After adequate eye opening and maintenance of airway reflexes patients would be transferred post anesthesia recovery unit. All patients are followed up by postoperatively for 24 hours. Further patients will be assessed for the efficacy of post operative analgesia using the VAS score and will be monitored for other variables such as complications. |