| CTRI Number |
CTRI/2025/12/098878 [Registered on: 11/12/2025] Trial Registered Prospectively |
| Last Modified On: |
09/12/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Ultrasound versus landmark method for spinal anaesthesia in obese pregnant women |
|
Scientific Title of Study
|
Comparison of Ultrasound guided and Landmark based Subarachnoid Block in Obese Parturients |
| 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 Ashima Grace Thomas |
| Designation |
Junior Resident |
| Affiliation |
Jubilee Mission Medical College and Research Institute |
| Address |
Department of Anaesthesiology, Jubilee Mission Medical College and Research Institute , Fathima Nagar, Mahatma Nagar, Nellikunnu, Thrissur
Thrissur
KERALA
680005
India |
| Phone |
9495955804 |
| Fax |
|
| Email |
ashimagracethomas804@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sugatha Prakash |
| Designation |
Professor |
| Affiliation |
Jubilee Mission Medical College and Research Institute |
| Address |
Department of Anaesthesiology, Jubilee Mission Medical College and Research Institute , Fathima Nagar, Mahatma Nagar, Nellikunnu, Thrissur
KERALA
680005
India |
| Phone |
9633397003 |
| Fax |
|
| Email |
sugatha234@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sugatha Prakash |
| Designation |
Professor |
| Affiliation |
Jubilee Mission Medical College and Research Institute |
| Address |
Department of Anaesthesiology, Jubilee Mission Medical College and Research Institute , Fathima Nagar, Mahatma Nagar, Nellikunnu, Thrissur
Thrissur
KERALA
680005
India |
| Phone |
9633397003 |
| Fax |
|
| Email |
sugatha234@gmail.com |
|
|
Source of Monetary or Material Support
|
| Jubilee Mission Medical College and Research Institute , Fathima Nagar, Mahatma Nagar, Nellikunnu, Thrissur, Kerala 680005 |
|
|
Primary Sponsor
|
| Name |
Dr Ashima Grace Thomas |
| Address |
Department of Anaesthesiology, Jubilee Mission Medical College and Research Institute , Fathima Nagar, Mahatma Nagar, Nellikunnu, Thrissur, Kerala 680005 |
| 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 Ashima Grace Thomas |
Jubilee Mission Medical College and Research Institute |
Department of Anaesthesiology, First Floor , Old block,Fathima Nagar, Mahatma Nagar, Nellikunnu, Thrissur, Kerala 680005
Thrissur
KERALA |
9495955804
ashimagracethomas804@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, Jubilee Mission Medical College and Research Institute |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O94-O9A||Other obstetric conditions, not elsewhere classified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Landmark based approach |
Landmark based subarachnoid blocks in obese parturients observed over one year |
| Intervention |
Ultrasound guided approach |
Ultrasound guided subarachnoid blocks in obese parturients observed over one year |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Female |
| Details |
1. ASA II or III obese parturients (pre pregnancy BMI more than or equal to 25 kilogram per metre cubed) undergoing elective or emergency caesarean section.
2. Singleton pregnancy at term (greater than 37 weeks).
3. No contraindications to spinal anaesthesia. |
|
| ExclusionCriteria |
| Details |
1. Patients with spinal deformities or previous spinal surgery.
2. Contraindications to neuraxial anaesthesia (coagulopathy, infection at puncture site, allergy to local anaesthetics, psychiatric illness).
3. Patients requiring emergency caesarean section for foetal distress. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| First pass success rate and number of needle passes |
First pass success rate and number of needle passes at the time of performing subarachnoid block |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Number of needle puncture attempts |
Till successful spinal achieved |
| Total procedure time for a successful puncture |
Till CSF backflow |
| Patient satisfaction score |
1 hour post procedure |
| Incidence of complications ( PDPH, failed block, traumatic tap) |
1 day post procedure |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
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)
|
01/01/2026 |
| 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)
|
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 - NO
|
|
Brief Summary
|
There is growing interest in the use of ultrasound guidance in different patient populations, it being noninvasive. Obesity in parturients is of concern with regard to performing subarachnoid block which is the preferred choice for cesarean section. This study has been undertaken to assess the benefit of ultrasound as a tool for better patient outcome and care. |