| CTRI Number |
CTRI/2024/09/074123 [Registered on: 20/09/2024] Trial Registered Prospectively |
| Last Modified On: |
07/07/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Medical Device
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Effect of early ambulation on post dural puncture headache after surgery under spinal anaesthesia with 27 G whitacre spinal needle |
|
Scientific Title of Study
|
Effect of early ambulation on post dural puncture headache with 27 G Whitacre spinal anaesthesia needle at tertiary care centre A prospective randomized single blind clinical trial
|
| 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 Satyendra Yadav |
| Designation |
Senior consultant NBEMS and Associate professor anaesthesiology |
| Affiliation |
Veer Chandra Singh Garhwali Government institute of medical sciences |
| Address |
Department of anesthesiology and critical care Veer Chandra Singh Garhwali government institute of medical science Srinagar Pauri Garhwal
Garhwal
UTTARANCHAL
246174
India |
| Phone |
9410110479 |
| Fax |
01346244701 |
| Email |
satyendra.homein@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Ashish Rana |
| Designation |
DNB FIRST YEAR RESIDENT |
| Affiliation |
Veer Chandra Singh Garhwali Government institute of medical sciences |
| Address |
Department of anesthesiology and critical care Veer Chandra Singh Garhwali government institute of medical science Srinagar Pauri Garhwal
Garhwal
UTTARANCHAL
246174
India |
| Phone |
8178737154 |
| Fax |
01346244701 |
| Email |
ashishrana.ar66@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Satyendra Yadav |
| Designation |
Senior consultant NBEMS and Associate professor anaesthesiology |
| Affiliation |
Veer Chandra Singh Garhwali Government institute of medical sciences |
| Address |
Department of anesthesiology and critical care Veer Chandra Singh Garhwali government institute of medical science Srinagar Pauri Garhwal
Garhwal
UTTARANCHAL
246174
India |
| Phone |
9410110479 |
| Fax |
01346244701 |
| Email |
satyendra.homein@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of anaesthesiology
Veer Chandra Singh Garhwali Government Institute of medical Sciences and Research
Srikot Srinagar Pauri Garhwal
pincode 246178 Uttrakhand India |
|
|
Primary Sponsor
|
| Name |
Veer chandra singh garhwali government institute of medical sciences |
| Address |
Department of anaesthesiology and critical care
Veer chandra singh garhwali government institute of medical sciences Srikot Srinagar Pauri Garhwal pin code 246178 Uttrakhand India |
| Type of Sponsor |
Research institution and hospital |
|
|
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 Satyendra Yadav MD MAMS |
Veer chandra singh Garhwali government institute of medical sciences and research |
Department of Anaesthesiology and Critical care
Garhwal
UTTARANCHAL |
8178737154
01346244701
ashishrana.ar66@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Veer chandra singh garhwali Instituitnal ethical committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O||Medical and Surgical, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Group B is the comparator group In group B ambulation done in 6 hours of spinal anaesthesia and evaluate for post dural puncture headache |
Patient are parallel grouped in group A and Group B In Group A patient ambulation done at 2 hours of spinal anesthesia and evaluated for incidence character and severity of Post dural puncture headache In group B patient are ambulation done at 6 hours of spinal anesthesia and evaluate for incidence character and severity of post dural puncture headache
|
| Intervention |
Spinal anesthesia with Whitacre 27 G spinal needle in patient undergoing surgery below T10 dermatome level |
Spinal anesthesia with Whitacre 27 G spinal needle in patient undergoing surgery below T10 dermatome level
Patient are parallel grouped in group A and Group B
In Group A patient ambulation done at 2 hours of spinal anesthesia and evaluated for incidence character and severity of Post dural puncture headache
In group B patient ambulation done at 6 hours of spinal anesthesia and evaluate for incidence character and severity of post dural puncture headache i |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
ASA Grade 1 and Grade 2
Age 18 years to 60 years
Elective general and orthopedic surgery below T10 dermatome level |
|
| ExclusionCriteria |
| Details |
Patients not willing for the spinal anesthesia procedure
Patients with ASA grade more than 2
Patient age more than 60 years
Patients with bleeding disorders
Obstetrics patients
Patients with documented allergy to Bupivacaine
If dose of injection Bupivacaine more than 3 ml
Surgical procedure lasting more than 90 minutes
Patients with any co morbid conditions requiring treatment
Bloody tap following sub arachnoid puncture
BMI more than 24 |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
To evaluate the effect of early ambulation following spinal anesthesia with Whitacre
spinal needle on post dural puncture headache (PDPH) in surgical patients.
II. To study incidence and characteristics of post dural puncture headache (PDPH)
following spinal anesthesia with Whitacre spinal needle in relation to early versus
restricted ambulation in surgical patients. |
Group A Early ambulation observed for post dural puncture headache in perioperative period and headache after ambulation at h 2 hours 4 hours 6 hours 8 hours 12 hours 18 hours 24 hours 36 hours 48 hours and 72 hours of spinal anesthesia
Group B Restricted ambulation observed for headache in perioperative period and after ambulation at 6 hours 8 hours 12 hours 18 hours 24 hours 36 hours 48 hours and 72 hours. of spinal anetheisa
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To study the ease of lumbar puncture and failure rate of spinal anesthesia with
Whitacre 27 G spinal needle |
Group A Early ambulation at 2 hours of spinal anaesthesia
Group B Restricted ambulation at 6 hours of spinal anaetheisa |
|
|
Target Sample Size
|
Total Sample Size="64"
Sample Size from India="64"
Final Enrollment numbers achieved (Total)= "64"
Final Enrollment numbers achieved (India)="64" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
25/09/2024 |
| Date of Study Completion (India) |
30/09/2025 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Completed |
Publication Details
Modification(s)
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Those patient will be recurited who are coming for preanesthetic checkup before surgery in department of anaesthesiology and critical care Veer Chandra Singh Garhwali Government Institute of medical Sciences and Research Srinagar Pauri Garhwal |