| CTRI Number |
CTRI/2024/07/070352 [Registered on: 10/07/2024] Trial Registered Prospectively |
| Last Modified On: |
09/07/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
To compare the effect of spinal anaesthesia while administering in lateral and sitting position in abdominal hysterectomy patients |
|
Scientific Title of Study
|
Comparison of sitting versus lateral position for performing sub arachnoid block in abdominal hysterectomy patients |
| 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 Catherine Singh |
| Designation |
Junior resident |
| Affiliation |
Peoples College of medical science and research center |
| Address |
Room 1
First floor
Anaesthesia department
Peoples hospital
Bhanpur Bhopal
Bhopal
MADHYA PRADESH
462037
India |
| Phone |
9806543342 |
| Fax |
|
| Email |
drcatherinesingh@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Akanksha Agrawal |
| Designation |
Professor |
| Affiliation |
Peoples College of medical science and research center |
| Address |
Room 2
First floor
Anaesthesia department
Peoples Hospital
Bhanpur Bhopal
Bhopal
MADHYA PRADESH
462037
India |
| Phone |
8989147838 |
| Fax |
|
| Email |
akankshaagarwal2020@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Akanksha Agrawal |
| Designation |
Professor |
| Affiliation |
Peoples College of medical science and research center |
| Address |
Room 2
First floor
Anaesthesia department
Peoples Hospital
Bhanpur Bhopal
Bhopal
MADHYA PRADESH
462037
India |
| Phone |
8989147838 |
| Fax |
|
| Email |
akankshaagarwal2020@gmail.com |
|
|
Source of Monetary or Material Support
|
| Peoples hospital , peoples College of medical science, karond bypass road bhanpur, Bhopal Madhya pradesh 462037 |
|
|
Primary Sponsor
|
| Name |
Peoples College of medical science and research center |
| Address |
Peoples University karond bypass road bhanpur Bhopal Madhya pradesh 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 Catherine Singh |
Peoples Hospital |
Room no 1 1st Floor Peoples Hospital Karond Bypass Road Bhanpur Bhopal 462037
Bhopal
MADHYA PRADESH |
9806543342
drcatherinesingh@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Commitee PCMS and RC |
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 |
| Intervention |
Bupivacaine heavy in sitting position |
Patients for elective abdominal hysterectomy will be administered intrathecal Bupivacaine heavy 3.4ml in sitting position |
| Comparator Agent |
Bupivacaine heavy intrathecal in lateral position |
Patient for elective abdominal hysterectomy will be administered with Bupivacaine heavy intrathecal 3.4ml in lateral position |
|
|
Inclusion Criteria
|
| Age From |
35.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Female |
| Details |
American society of ANAESTHESIOLOGISTS grade 1 and 2 .
Patients for elective abdominal hysterectomy. |
|
| ExclusionCriteria |
| Details |
Patients not giving consent.
ASA grade 3 or more.
Anatomical deformities of spine.
Coagulopathy or bleeding disorders.
Infection at lumbar region of spine.
Hemodynamic instability.
Any neurological disorder.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Blood pressure |
30 minutes |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Ease of spinal anaesthesia & haemodynamic parameters |
30 minutes |
|
|
Target Sample Size
|
Total Sample Size="120"
Sample Size from India="120"
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
|
Phase 3 |
|
Date of First Enrollment (India)
|
20/07/2024 |
| 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
|
for this study patients will be divided into 2 groups group s and group l. After thorough assessment and pre anaesthetic checkup of patient , patient will be divided into groups based on computer based randamizaion .patients in group S will receive sub arachnoid block in sitting position while patients in group L will receive sub arachnoid block in lateral position. patients will be assessed and compared the effects based on haemodynamic changes like blood pressure , onset of sensory and motor block . |