| CTRI Number |
CTRI/2025/08/092516 [Registered on: 06/08/2025] Trial Registered Prospectively |
| Last Modified On: |
01/08/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Cohort Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
All postoperative headaches are not PDPH.A Observational study on postoperative headache and optic nerve sheath diameter |
|
Scientific Title of Study
|
Observational study on postoperative headaches and changes in optic nerve sheath diameter in cesarean section after 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 |
S Kalyani Surya Dhana Lakshmi |
| Designation |
Additional professor |
| Affiliation |
AIIMS BIBINAGAR |
| Address |
Department of Anesthesiology, Bibinagar, AIIMS Bibinagar, Hyderabad
Hyderabad
TELANGANA
508126
India |
| Phone |
7893720606 |
| Fax |
|
| Email |
sksdhanalakshmi@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
GOGULA SNEHA |
| Designation |
senior resident |
| Affiliation |
AIIMS BIBINAGAR |
| Address |
Department of Anesthesiology, Bibinagar, All India Institute of Medical Sciences, Bibinagar, Hyderabad Metropolitan region
Hyderabad
TELANGANA
508126
India |
| Phone |
9493677889 |
| Fax |
|
| Email |
snehagkkd@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
S Kalyani Surya Dhana Lakshmi |
| Designation |
Additional professor |
| Affiliation |
AIIMS BIBINAGAR |
| Address |
Department of Anesthesiology, Bibinagar, AIIMS Bibinagar, Hyderabad
Hyderabad
TELANGANA
508126
India |
| Phone |
7893720606 |
| Fax |
|
| Email |
sksdhanalakshmi@gmail.com |
|
|
Source of Monetary or Material Support
|
| All India Institute of Medical sciences, Bibinagar, Hyderabad Metropolitan Region, Telangana-508126 |
|
|
Primary Sponsor
|
| Name |
All India Institute of Medical Sciences Bibinagar |
| Address |
All India Institute of Medical Sciences Bibinagar, Hyderabad Metropolitan Region, Telangana |
| 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 G Sneha |
ALL INDIA INSTITUTE OF MEDICAL SCIENCES, Bibinagar |
Room no G35 and G36, Operation theater complex, Department of Anaesthesiology, All India Institute of Medical Sciences, Bibinagar, Hyderabad Metropolitan Region
Hyderabad
TELANGANA |
09493677889
snehagkkd@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee(AIIMS BBN-IEC) |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O00-O9A||Pregnancy, childbirth and the puerperium, |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Female |
| Details |
1) ASA Physical Status of 2 and 3
2) Patients undergoing LSCS under SA with 25guage spinal needle
|
|
| ExclusionCriteria |
| Details |
1) spinal anaesthesia failure and converted to GA
2) Bleeding disorders
3) Patient refusal
4) Patients on Anti-coagulants
5) Infections and lesions at puncture site
6) Patients with allergy to drugs
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Incidence of postoperative headache in LSCS patients done under spinal anesthesia patients
Changes in ONSD in preoperative and postoperative periods in patients complaining of headache
Incidence of PDPH out of all headaches
Incidence of headache in association with no of spinal attempts intraoperative hypotension, amount of vasopressors used and type of spinal drug used
|
Incidence of postoperative headache in LSCS patients done under spinal anesthesia patients within 5days postoperatively
Changes in ONSD in preoperative and postoperative periods 24th and 48th hour
Incidence of PDPH out of all headaches 5days postoperatively
Incidence of headache in association with no of spinal attempts intraoperative hypotension amount of vasopressors used and type of spinal drug used 5days postoperatively
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Differentiating types of headache |
Till 5th postoperative day |
|
|
Target Sample Size
|
Total Sample Size="363"
Sample Size from India="363"
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)
|
01/09/2025 |
| 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="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| 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
|
Headaches are a common neurological complaint during pregnancy and the postpartum period · Most are primary and benign, but there are also several secondary headaches. · Anesthesiologist should be aware of the importance of carefully observing these headache characteristics, associated symptoms, in order to give differential diagnoses and provide appropriate treatment. · By clinical observation incidence of headache in postoperative period is relatively less in Indian population. However, there are no studies available on the total incidence of headaches in Indian population. There is no literature differentiating various headaches from PDPH after cesarian section in Indian population. · ONSD as a predictor of Post-dural Puncture Headache (PDPH) following spinal anesthesia could have significant implications for clinical practice. · By providing a reliable, non-invasive method to assess patient risk. | |