| CTRI Number |
CTRI/2024/05/066666 [Registered on: 02/05/2024] Trial Registered Prospectively |
| Last Modified On: |
15/12/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cohort Study |
| Study Design |
Other |
|
Public Title of Study
|
Comparison of landmark versus ultrasound guided technique for spinal anesthesia in obese patients. |
|
Scientific Title of Study
|
Comparison Of Landmark Versus Ultrasound Guided Lumbar Puncture Technique In Obese Patients Undergoing Total Knee Replacement Surgery Under Spinal Anaesthesia |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Kalariya Parthikkumar Mansukhlal |
| Designation |
Junior Resident |
| Affiliation |
Army Hospital Research and Referral |
| Address |
Department of Anaesthesiology and Critical Care , Army Hospital Research and Referral, Delhi Cantt - 110010
South West
DELHI
110010
India |
| Phone |
9409454878 |
| Fax |
|
| Email |
parthikk@yahoo.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Brig (Dr) Parmeet Bhatia |
| Designation |
Professor Anaesthesiology and Critical Care |
| Affiliation |
Army Hospital Research and Referral |
| Address |
Department of Anaesthesiology and Critical Care , Army Hospital Research and Referral, Delhi Cantt - 110010
South West
DELHI
110010
India |
| Phone |
9815599269 |
| Fax |
|
| Email |
drparmeetbhatia@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Kalariya Parthikkumar Mansukhlal |
| Designation |
Junior Resident |
| Affiliation |
Army Hospital Research and Referral |
| Address |
Department of Anaesthesiology and Critical Care , Army Hospital Research and Referral, Delhi Cantt - 110010
South West
DELHI
110010
India |
| Phone |
9409454878 |
| Fax |
|
| Email |
parthikk@yahoo.in |
|
|
Source of Monetary or Material Support
|
| Army Hospital Research and Referral |
| individual |
|
|
Primary Sponsor
|
| Name |
Kalariya Parthikkumar Mansukhlal |
| Address |
Department of Anaesthesiology and Critical Care , Army Hospital Research and Referral, Delhi Cantt - 110010 |
| 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 |
| Kalariya Parthikkumar Mansukhlal |
Army Hospital Research and Referral |
Department of Anaesthesia and Critical Care, 2nd Floor, Room No.2, New Delhi 110010
South West
DELHI |
9409454878
parthikk@yahoo.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee Army Hospital Research and Referral |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: U07-U07||Provisional assignment of new diseases of uncertain aetiology or emergency use (U00-U49), |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Landmark guided lumbar puncture technique for spinal anaesthesia |
Landmark guided lumbar puncture technique for spinal anaesthesia injection bupivacaine 0.5% heavy 2.2 ml |
| Intervention |
Ultrasound guided lumbar puncture technique for spinal anaesthesia |
Ultrasound guided lumbar puncture technique for spinal anaesthesia, injection bupivacaine 0.5% heavy 2.2 ml |
|
|
Inclusion Criteria
|
| Age From |
45.00 Year(s) |
| Age To |
85.00 Year(s) |
| Gender |
Both |
| Details |
BMI more than 27 kg/m2, patients undergoing surgery under neuraxial block, patients giving valid informed consent |
|
| ExclusionCriteria |
| Details |
patient refusal, Patients with spinal deformity, neurological diseases, coagulation disorders, local infections, unstable hemodynamics |
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| to evaluate mean difference of puncture attempts and success rate of dural puncture on first needle insertion attempt in ultrasound guided and landmark guided technique for spinal anaesthesia in obese patients. |
baseline, 4 month, 6 month |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
to compare both groups in terms of
Lumar puncture time from skin puncture to csf outflow
adverse events or complications following dural puncture |
baseline, 4 months, 6 months |
|
|
Target Sample Size
|
Total Sample Size="50"
Sample Size from India="50"
Final Enrollment numbers achieved (Total)= "68"
Final Enrollment numbers achieved (India)="68" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
11/05/2024 |
| Date of Study Completion (India) |
30/07/2024 |
| Date of First Enrollment (Global) |
11/05/2024 |
| Date of Study Completion (Global) |
30/07/2024 |
|
Estimated Duration of Trial
|
Years="1"
Months="6"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Completed |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
none yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Subarachnoid Block produces a quick sensory and good motor block
through the injection of local anaesthetic to the subarachnoid space. Spinal
anaesthesia is traditionally performed using the palpation of bony landmarks to
identify the level and point of the needle insertion, together with tactile
feedback during needle insertion.
The success of traditional lumbar puncture mainly depends on the
accurate positioning of the puncture point. The accurate location of the
puncture point was mainly based on the anatomical landmarks, through the
Tuffler’s line (the transverse line connecting the superior aspects of the iliac
crests) and touching the interspace of the spinous process. However, the
actual level of Tuffler’s line may vary from the L4 body to the L5 body, the line
is insufficient to use for assessing spinal segmental level.
If the patient is obese, the subcutaneous fat layer is thickened, the
ligament and bony landmarks are not displayed clearly, the traditional lumbar
puncture method is more difficult, greatly increasing the possibility of failure.
Ultrasound (US) imaging has become an increasingly popular tool among
anaesthesiologists to guide neuraxial blockade. Studies have shown that
Ultrasonography facilitates the performance of spinal anaesthesia in patients in
whom technical difficulties are expected. Ultrasound window provides an
enhanced visibility of the neuraxis and surrounding structures.
In this prospective, observational study we hypothesized that Ultrasound
guided spinal anaesthesia would result in reduced puncture attempts and
improved success rates at first attempt when compared with the conventional
landmark-guided technique in obese patients |