| CTRI Number |
CTRI/2024/07/071395 [Registered on: 26/07/2024] Trial Registered Prospectively |
| Last Modified On: |
27/07/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
Type of Study
Modification(s)
|
Prospective comparative |
| Study Design |
Other |
|
Public Title of Study
|
A Comparison Of Incidence Of Headaches After Spinal Anesthesia Using Different Spinal Needles |
|
Scientific Title of Study
|
A Comparison Of Incidence Of Post Dural Puncture Headache With 25G Quincke’s And 25G Whitacre’s Spinal Needles Following 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 |
Dr Disney Das |
| Designation |
Junior Resident |
| Affiliation |
KS Hegde Medical Academy |
| Address |
Department of Anesthesiology
KS Hegde Medical Academy
Derlakatte
Mangaluru
Dakshina Kannada KARNATAKA 575018 India |
| Phone |
9706429694 |
| Fax |
|
| Email |
Disneydas14@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Anil Shetty |
| Designation |
Professor |
| Affiliation |
KS Hegde Medical Academy |
| Address |
Department of Anesthesiology
KS Hegde Medical Academy
Derlakatte
Mangaluru
Dakshina Kannada KARNATAKA 575018 India |
| Phone |
9448012303 |
| Fax |
|
| Email |
shetty.anil10@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Dr Anil Shetty |
| Designation |
Professor |
| Affiliation |
KS Hegde Medical Academy |
| Address |
Department of Anesthesiology
KS Hegde Medical Academy
Derlakatte
Mangaluru
Dakshina Kannada KARNATAKA 575018 India |
| Phone |
9448012303 |
| Fax |
|
| Email |
shetty.anil10@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Dr Disney Das |
| Address |
Department of Anaesthesiology
KS Hegde Medical Academy
PO Derlakatte
Mangaluru
575018 |
| 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 Disney Das |
KS Hegde Medical Academy |
Deparment of Anaesthesiology
1st floor
KS Hegde Medical Academy
PO Derlakatte
Managluru - 575018 Dakshina Kannada KARNATAKA |
9706429694
disneydas14@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| KS Hedge Medical Academy Institutional Ethics Commitee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
NIL |
|
Intervention / Comparator Agent
Modification(s)
|
| Type |
Name |
Details |
| Intervention |
Nil |
25G Quincke vs 25G Whitacre needle used in respective groups and post dural puncture headache incidence observed. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1. Patients in the age group of 18 to 65 years undergoing SAB using 25G Quincke
needle or Whitacre needle.
2. ASA PS I and II. |
|
| ExclusionCriteria |
| Details |
Pregnant patients
Intraop General anesthesia administration
Migraine or other neurological or chronic headache patients
BMI more than 35 |
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Incidence of post dural puncture headache |
Daily from post operative period upto post operative day 10. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Onset |
Onset evaluated at Postoperative day 1 to Postoperative day 10. |
| Postural effect |
Daily at post operative day 1 to post operative day 10. |
| Any associated symptoms present? |
At post operative day 1 to post operative day 10. |
|
|
Target Sample Size
|
Total Sample Size="86" Sample Size from India="86"
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) |
15/08/2024 |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="2" Months="0" Days="0" |
|
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
|
Participants satisfying the inclusion criteria will be evaluated after obtaining informed written consent. A thorough pre-anaesthetic evaluation will be done a day prior to surgery. Patient shall be prepared as per institutional protocol. All patients will be coloaded with 500 ml of appropriate IV fluid as per standard institutional protocol. As per the standard procedure, using the midline approach of spinal anaesthesia using Quincke’s or Whitacre’s spinal needle will be inserted into L3-L4 subarachnoid space and 0.5% of hyperbaric bupivacaine will be injected into the space by a trained anaesthesiologist. Level of sensory and motor block will be assessed. All the non-invasive hemodynamic monitoring will be used to record the vitals. Patient and the observer will be blinded from the type of needle used for spinal anaesthesia. All patients will be examined on the day of surgery and there after every day for the next ten days. The patients will be assessed on post operative day one for signs of PDPH and followed up till day ten. After day of discharge, will be followed up via telephonic communication. The following information will be collected from the anaesthesiologist giving the subarachnoid block about the type of needle used, size, approach, position, number of attempts, ease of puncture. After assessing the patients on POD10 about headache with regards to its severity, onset, effect of posture and associated symptoms like nausea, vomiting, auditory and ocular symptoms the patients will be allocated into groups Q and W after obtaining information regarding the procedure from the anaesthesiologist. Accordingly, assessment of more than the sample size will be done and patients not satisfying the inclusion criteria will be excluded based on usage of different type and size of needle used. Study will be concluded once the sample size is reached. The collected data will be entered into MS Excel followed by the analysis using SPSS version 22/R Core Team (2023). The comparison of post dural puncture headache following spinal anaesthesia, ease of puncture and number of attempts between the two groups will be done using Chi Square test/ Fishers exact test/Proportion test. P value<0.05 will be considered statistically significant. |