| CTRI Number |
CTRI/2024/07/070670 [Registered on: 16/07/2024] Trial Registered Prospectively |
| Last Modified On: |
14/07/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparison of crossed legged sitting position versus Traditional sitting position forthe ease of insertion of Epidural catheter in patients posted for hysterectomy |
|
Scientific Title of Study
|
Comparision of crossed legged sitting position with traditional sitting position for the ease of insertion of Epidural catheter in patients posted for hysterectomy |
| Trial Acronym |
No |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Akansha Joshi |
| Designation |
Post graduate |
| Affiliation |
Peoples college of Medical Sciences and Research Center Bhopal |
| Address |
Room no 1 first floor Department of Anaesthesia People’s college of Medical Sciences and Research Center
Bhopal
MADHYA PRADESH
462037
India |
| Phone |
8349718336 |
| Fax |
|
| Email |
akanshajoshi29@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Abhilekh Jain |
| Designation |
Professor |
| Affiliation |
Peoples college of Medical Sciences and Research Center |
| Address |
Room 2 First floor department of Anaesthesia Peoples college of Medical Sciences and Research Centre
Bhopal
MADHYA PRADESH
462037
India |
| Phone |
9827606268 |
| Fax |
|
| Email |
jainabhilekh@rediffmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Akansha Joshi |
| Designation |
Post graduate |
| Affiliation |
Peoples college of Medical Sciences and Research Center |
| Address |
Room 1 first floor Department of Anaesthesia Peoples college of Medical Sciences and Research Center
Vidisha
MADHYA PRADESH
462037
India |
| Phone |
8349718336 |
| Fax |
|
| Email |
akanshajoshi29@gmail.com |
|
|
Source of Monetary or Material Support
|
| Peoples hospital and peoples college of Medical Sciences and Research Centre Bhopal Madhya Pradesh 462037 |
|
|
Primary Sponsor
|
| Name |
Peoples college of Medical Sciences and Research center |
| Address |
Peoples college of Medical Sciences and Research Center Bhanpur Bhopal 462037 |
| 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 |
| Dr Akansha joshi |
Peoples hospital |
Room 1 first floor Department of Anaesthesia Peoples college of Medical Sciences and Research Centre Bhanpur Bhopal Madhya Pradesh
Bhopal
MADHYA PRADESH |
8349718336
akanshajoshi29@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional 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 |
Epidural insertion in crossed legged sitting position |
This group of patients will be seated in crossed legged sitting position for epidural catheter insertion and will be assessed for ease of insertion |
| Intervention |
Epidural insertion in Traditional sitting position |
This group patients willbe seated in traditional sitting position for epidural catheter insertion and will be assessed for ease of insertion |
|
|
Inclusion Criteria
|
| Age From |
40.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Female |
| Details |
ASA Grade 1 and 2
Patient scheduled for elective Hysterectomy |
|
| ExclusionCriteria |
| Details |
Uncooperative Patients
Significant Anatomical disorder of the Spine and Hip
Body mass index more than 30kg per metre square
Patient belonging to ASA Grade more than or equal to 3
Severe infection or Wound in the Lumbar area
History of serious pulmonary disease or ischaemic heart disease or
renal dysfunction and patients with abnormal coagulation profile |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Ease of insertion of Epidural catheter |
30 minutes |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Hemodynamic parameters |
30 minutes |
|
|
Target Sample Size
|
Total Sample Size="140"
Sample Size from India="140"
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)
|
25/07/2024 |
| 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="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
|
We are going to compare between 2 sitting position Traditional sitting position versus Crossed legged sitting position for the ease of insertion of Epidural catheter in patients posted for hysterectomy |