| CTRI Number |
CTRI/2026/03/105904 [Registered on: 11/03/2026] Trial Registered Prospectively |
| Last Modified On: |
10/03/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Follow Up Study |
| Study Design |
Other |
|
Public Title of Study
|
Study to Find How Often Headache Occurs After Spinal Anaesthesia in Patients Undergoing Knee Ligament Surgery |
|
Scientific Title of Study
|
Incidence of Post-Dural Puncture Headache (PDPH) in Patients Undergoing
Surgery for Knee Ligament Tear Under Spinal Anaesthesia – A Prospective Observational Study. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Naineesh Shahir |
| Designation |
Junior Resident |
| Affiliation |
Kasturba Medical College , Manipal |
| Address |
Department of Anaesthesia ,
Kasturba Medical College , Manipal , Karnataka
Udupi
KARNATAKA
576104
India |
| Phone |
9850474040 |
| Fax |
|
| Email |
shahir.kmcmpl2024@learner.manipal.edu |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sushma TK |
| Designation |
Additional Professor |
| Affiliation |
Kasturba Medical College , Manipal |
| Address |
Department of Anaesthesia Kasturba Medical College , Manipal , Karnataka
Udupi
KARNATAKA
576104
India |
| Phone |
9964620729 |
| Fax |
|
| Email |
drsushmagowda@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sushma TK |
| Designation |
Additional Professor |
| Affiliation |
Kasturba Medical College , Manipal |
| Address |
Department of Anaesthesia Kasturba Medical College , Manipal , Karnataka
Udupi
KARNATAKA
576104
India |
| Phone |
9964620729 |
| Fax |
|
| Email |
drsushmagowda@gmail.com |
|
|
Source of Monetary or Material Support
|
| Kasturba Medical College and Kasturba Hospital , Manipal Academy of Higher Education , 576104 , Udupi , Karnataka |
|
|
Primary Sponsor
|
| Name |
Kasturba Medicaal College and Kasturba Hospital |
| Address |
asturba Medical College and Kasturba Hospital , Manipal Academy of Higher Education , 576104 , Udupi , Karnataka |
| Type of Sponsor |
Private 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 |
| Naineesh Shahir |
Kasturba Medical College and Kasturba Hospital , Manipal |
Department of Anaesthesiology ,Tiger Circle Road , Madhav Nagar , Manipal , 576104 , Udupi ,Karnataka
Udupi
KARNATAKA |
09850474040
shahir.kmcmpl2024@learner.manipal.edu |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Kasturba Medical College and Kasturba Hospital Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Knee Ligament Injuries |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
1]Adults aged 18–50 years undergoing elective knee ligament tear surgery under spinal anaesthesia
2]ASA physical status I or II
3]Willing to provide informed consent and comply with follow-up
|
|
| ExclusionCriteria |
| Details |
Exclusion Criteria
1]Known history of chronic headache, migraine, or psychiatric disorders
2]Neurological disease or spinal deformities
3]Infection at the puncture site
4]Coagulopathy or anticoagulant use
•Allergy to local anaesthetics
•Conversion to general anaesthesia
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| •Incidence of PDPH at 0, 24, and 48 hours post spinal anaesthesia |
•Incidence of PDPH at 0, 24, and 48 hours post spinal anaesthesia |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1]To assess the time of onset & duration of PDPH post-spinal anaesthesia.
2]To evaluate the severity of PDPH at 0, 24, & 48 hours using the Visual Analog Scale (VAS).
3]To identify associated risk factors for PDPH, including age, sex, BMI, needle gauge, number of attempts, & history of headache |
Immediately after procedure , 24 hours & 48 hours after procedure |
|
|
Target Sample Size
|
Total Sample Size="55"
Sample Size from India="55"
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)
|
02/04/2026 |
| 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="6"
Days="2" |
|
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
|
PDPH is a well documented iatrogenic complication of spinal anaesthesia that occurs due to persistent cerebrospinal fluid leakage through the dural puncture site , resulting in intracranial hypotension . Although self limiting , PDPH can significantly delay postoperative recovery , prolong hospital stay and cause considerable patient distress. In context to knee ligament surgeries - a common orthopaedic procedure in younger , active populations understanding PDPH burden becomes essential . These patients may exhibit heightened susceptibility due to demographic factors and urgency of functional recovery post surgery . Several global and Indian studies have investigated PDPH across diverse populations including obstetric and general surgery cohort however very few have focused specifically on elective orthopedic patients undergoing surgery for knee ligament injuries. |