| CTRI Number |
CTRI/2024/08/071890 [Registered on: 05/08/2024] Trial Registered Prospectively |
| Last Modified On: |
31/07/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A study to compare the accuracy of using ultrasound versus landmark guided method for locating subarachnoid space in patients having cesarean delivery under spinal anaesthesia |
|
Scientific Title of Study
|
A randomized controlled study to compare the accuracy of pre-procedural ultrasound versus conventional landmark method for locating subarachnoid space in patients undergoing cesarean delivery under spinal anaesthesia |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Harsh Kaul |
| Designation |
PG resident |
| Affiliation |
Lady hardinge medical College and associated hospitals, New Delhi |
| Address |
Department of Anaesthesia,
Lady hardinge medical college
Shaheed Bhagat Singh marg
Connaught place
Central DELHI 110001 India |
| Phone |
9599699038 |
| Fax |
|
| Email |
kaulrobin12@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Anshu Gupta |
| Designation |
Professor |
| Affiliation |
Lady hardinge medical college and associated hospitals , New Delhi |
| Address |
Department of Anaesthesia, Lady hardinge medical college,
Shaheed Bhagat Singh marg, connaught place
Central DELHI 110001 India |
| Phone |
9871158433 |
| Fax |
|
| Email |
dranshugupta1@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Dr Anshu Gupta |
| Designation |
Professor |
| Affiliation |
Lady hardinge medical college and associated hospitals , New Delhi |
| Address |
Department of Anaesthesia, Lady hardinge medical college, Shaheed Bhagat Singh marg, connaught place
DELHI 110001 India |
| Phone |
9871158433 |
| Fax |
|
| Email |
dranshugupta1@gmail.com |
|
|
Source of Monetary or Material Support
|
| Lady Hardinge Medical College
Shaheed Bhagat Singh Marg, , DIZ Area, Connaught Place, New Delhi, Delhi, India 110001 |
|
|
Primary Sponsor
|
| Name |
lady hardinge medical college |
| Address |
department of anaesthesia lady hardinge medical college shahid bhagat singh marg, connaught place |
| Type of Sponsor |
Government 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 harsh kaul |
Lady hardinge medical college |
Department of Anaesthesia, Lady Hardinge Medical College, DIZ Area, Connaught Place, New Delhi, Delhi 110001 Central DELHI |
9599699038
kaulrobin12@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| institutional Ethics comittee for human research LHMC and associated hospitals, New Delhi |
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 |
landmark guided subarachnoid block |
palpation of posterior superior iliac spine using tuffiers line and L3-L4 or L4-L5 intervertebral space.0.5% heavy bupivacine (9-10mg) with 25mcg fentanyl will be administered at an injection rate of 0.1ml/s |
| Intervention |
ultrasound guided subarachnoid block |
L3-L4 inter vertebral space will be identified using ultrasound and pre-determined point of entry for the needle will be marked on patient’s back.0.5% heavy bupivacine (9-10mg) with 25mcg fentanyl will be administered at an injection rate of 0.1ml/s |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Female |
| Details |
Patients for elective cesarean delivery as categorized by RCOG (Royal College of Obstetricians and Gynaecologists) in categories III and IV |
|
| ExclusionCriteria |
| Details |
any contraindications of spinal anaethesia |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To compare the accuracy (in terms number of patients having successful needle first pass attempt) of pre-procedural ultrasound and conventional landmark method for locating subarachnoid space in patients undergoing cesarean delivery under spinal anaesthesia |
free flow of CSF in single attempt(time noted in seconds) |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1 To compare ultrasound depth of subarachnoid space with real needle to target distance in ultrasound group
2 Number of successful needle first pass attempt in patients of various BMI
3 Number of needle redirections
4 Number of skin punctures required
5 Number of attempted intervertebral spaces
6 Total procedure time
7 Patient satisfaction using five point Likert scale after 24 hours postoperatively
8 Complications such as headache backache incidence of bloody tap |
1 measure of target distance in ultrasound to free flow of CSF in the spinal needle hub
2 free flow of CSF
3 free flow of CSF
4 free flow of CSF
5 free flow of CSF
6 free flow of CSF
7 free flow of CSF in the spinal needle hub to 24 hours post operatively
8 free flow of CSF in the spinal needle hub to 24 hours post operatively
|
|
|
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)
|
15/08/2024 |
| 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="1" Days="18" |
|
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
|
Spinal anaesthesia is gold standard anaesthetic technique in obstetric patients because of lower complication rate and better neonatal outcome as compared to general anesthesia However in obstetric patients there are increased lumbar lordsis, obesity and soft tissue edema making spinal anesthesia technically more challenging ,also there are many more anatomical and physiological changes in pregnancy predisposing them to multiple needle pass attempts and increased difficulty in administrating successful subarachnoid block. Use of landmark method of locating subarachnoid space may sometime be inaccurate, which invariably leads to repeated attempts and redirections of the needle leading to complications such as bloody tap, nerve injury, spinal hematoma, paresthesia, postdural puncture headache, patient discomfort and dissatisfaction and delay in treatment which may sometimes also affect the neonatal outcome. Due to challenges associated with spinal anaesthesia in obstetric patients, pre-procedural ultrasound could be helpful in locating the subarachnoid space accurately thus decreasing the number of attempts and needle redirections while performing the subarachnoid block, reducing many complications. The existing literature explores the utility of pre-procedural ultrasound in various patient populations, but its application in obstetric anesthesia remains relatively underexplored. Therefore we planned our study in obstetric population which may guide about its utility routine practice. Administrating spinal anaesthesia is difficult in obstetric patients due to various anatomical and physiological changes. This causes multiple needle pass attempts leading to many complications such as bloody tap, nerve injury, spinal hematoma, paresthesia, post dural puncture headache, patient discomfort and dissatisfaction. Pre-procedural ultrasound may facilitate spinal anaesthesia by locating the accurate needle insertion point accurately in obstetric patients making the technique easier resulting in lesser needle first pass attempts, ultimately enhancing maternal and neonatal outcomes. There is a paucity of literature regarding utility of pre-procedural ultrasound for locating sub arachnoid space in obstetric patients, its superiority over the landmark technique has not been proven yet. |