| CTRI Number |
CTRI/2023/04/051628 [Registered on: 17/04/2023] Trial Registered Prospectively |
| Last Modified On: |
13/04/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
To study effect of hip-shoulder width ratio and waist-shoulder width ratio on cephalad spread of spinal Anesthesia in caesarean section; A prospective observational study |
|
Scientific Title of Study
|
To study effect of hip-shoulder width ratio and waist-shoulder width ratio on sensory level in sub arachnoid block in caesarean section; A prospective observational study |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Nihala Kareem M T |
| Designation |
DNB student , Department of Anesthesiology |
| Affiliation |
Shri Lal Bahadur Shastri Government medical College and hospital Nerchowk at Mandi Himachal Pradesh |
| Address |
Shri Lal Bahadur Shastri Government medical College and hospital Nerchowk at Mandi Himachal Pradesh
Mandi
HIMACHAL PRADESH
175021
India |
| Phone |
9496875929 |
| Fax |
|
| Email |
nihalamt2012@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Nihala Kareem M T |
| Designation |
DNB student , Department of Anesthesiology |
| Affiliation |
Shri Lal Bahadur Shastri Government medical College and hospital Nerchowk at Mandi Himachal Pradesh |
| Address |
Shri Lal Bahadur Shastri Government medical College and hospital Nerchowk at Mandi Himachal Pradesh
Mandi
HIMACHAL PRADESH
175021
India |
| Phone |
9496875929 |
| Fax |
|
| Email |
nihalamt2012@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Nihala Kareem M T |
| Designation |
DNB student , Department of Anesthesiology |
| Affiliation |
Shri Lal Bahadur Shastri Government medical College and hospital Nerchowk at Mandi Himachal Pradesh |
| Address |
Shri Lal Bahadur Shastri Government medical College and hospital Nerchowk at Mandi Himachal Pradesh
Mandi
HIMACHAL PRADESH
175021
India |
| Phone |
9496875929 |
| Fax |
|
| Email |
nihalamt2012@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Anesthesiology, Shri Lal Bahadur Shastri Government medical College and hospital Nerchowk at Mandi Himachal Pradesh |
|
|
Primary Sponsor
|
| Name |
Department of Anesthesiology |
| Address |
Shri Lal Bahadur Shastri Government medical College and hospital Nerchowk at Mandi Himachal Pradesh |
| 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 Anshit Pathania |
Shri Lal Bahadur Shastri medical college Nerchowk at Mandi, Himachal Pradesh |
Department of Anaesthesiology
Mandi
HIMACHAL PRADESH |
7018152725
apathania26@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| IEC SLBS Govt. Medical College |
Approved |
|
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Regulatory Clearance Status from DCGI
|
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Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: 1||Obstetrics, |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Female |
| Details |
Singleton pregnancy
Gestational age more than 37 weeks
Height between 150-170 cm |
|
| ExclusionCriteria |
| Details |
Fetal distress, neuromuscular diseases, hypovolemia or shock, Electrolyte imbalance, Infection on back, On anticoagulant therapy, Vertebral anomaly, Obstetric comorbidities, Medical comorbidities |
|
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Method of Generating Random Sequence
|
|
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Method of Concealment
|
|
|
Blinding/Masking
|
|
|
Primary Outcome
|
| Outcome |
TimePoints |
To determine the correlation between hip shoulder width ratio and sensory level of sub arachnoid block in parturient undergoing LSCS
To determine any correlation between waist-shoulder width ratio and sensory level of sub arachnoid block in parturient undergoing LSCS |
12 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Better predictor for cephalad spread- Hip shoulder width ratio or waist shoulder width ratio |
1 year |
|
|
Target Sample Size
|
Total Sample Size="120"
Sample Size from India="120"
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)
|
20/04/2023 |
| 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="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
Not yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Study conducted in 120 parturient ( excluding exclusion criteria) undergoing LSCS. Informed consent will be taken from patients. Detailed history and investigations will be checked.patient will be shifted to OT, monitors attached. Vitals will be noted. Hip circumference, waist circumference, shoulder width, height, weight noted. Sub arachnoid block given with inj Bupivaccaine 0.5% heavy 2 ml for all patients in lateral position. Patients made to lie in supine position with left lateral displacement. Spinal level checked every 1 minute for 5 minutes and then every 5 minutes for 30 minutes. Surgeon allowed to proceed once level become T6. Vitals are also monitored every 3 minutes and noted. Hip shoulder width ratio and waist-shoulder width ratio calculated. Objective to determine the correlation between hip shoulder width ratio and sensory level in sub arachnoid block and to determine any correlation between waist-shoulder width ratio and sensory level in sub arachnoid block. Also to ascertain whether hip shoulder width ratio or waist shoulder width ratio is a better predictor of cephalad spread of sub arachnoid block. |