| CTRI Number |
CTRI/2020/02/023169 [Registered on: 06/02/2020] Trial Registered Prospectively |
| Last Modified On: |
11/05/2022 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Spinal anaesthesia with bupivacaine with and without magnesium sulphate in patient undergoing uterus surgeries |
|
Scientific Title of Study
|
Comparison between epidural bupivacaine with and without magnesium sulphate in patient undergoing elective total abdominal hystrectomy - A randomised controlled trial |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Aishwarya Guru |
| Designation |
Post Graduate |
| Affiliation |
Shri sathya sai medical college and research institute |
| Address |
Department of anaesthesia Shri sathya medical college and research Institute Guduvanchery Thiruporur main road Ammapettai Nellikuppam Chengalpattu taluk
Kancheepuram
TAMIL NADU
603108
India |
| Phone |
9669450181 |
| Fax |
|
| Email |
aishwarya.gurus1994@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
S N Krishnamoorthy |
| Designation |
Professor |
| Affiliation |
Shri sathya sai medical college and research institute |
| Address |
Department of anaesthesia Shri sathya medical college and research Institute Guduvanchery Thiruporur main road Ammapettai Nellikuppam Chengalpattu taluk
Kancheepuram
TAMIL NADU
603108
India |
| Phone |
9786743120 |
| Fax |
|
| Email |
esenkeyem@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Aishwarya Guru |
| Designation |
Post Graduate |
| Affiliation |
Shri sathya sai medical college and research institute |
| Address |
Department of anaesthesia Shri sathya medical college and research Institute Guduvanchery Thiruporur main road Ammapettai Nellikuppam Chengalpattu taluk
Kancheepuram
TAMIL NADU
603108
India |
| Phone |
9669450181 |
| Fax |
|
| Email |
aishwarya.gurus1994@gmail.com |
|
|
Source of Monetary or Material Support
|
| Shri Sathya Sai Medical College and Research Institute Thiruporur Guduvanchery Main Road Ammapettai Nellikuppam Kancheepuram 603108 Tamil Nadu India
|
|
|
Primary Sponsor
|
| Name |
Aishwarya Guru |
| Address |
316 damoh road
Yagshala K pass
Tehsil Patharia
Damoh district
Madhya pradesh 470666 |
| 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 |
| Aishwarya Guru |
Shri sathya sai medical college and research institute |
OBG OT First Floor OT Complex Shri Sathya Sai Medical College and Research Institute Thiruporur Guduvanchery Main Road Ammapettai Nellikuppam Kancheepuram 603108 Tamil Nadu India Kancheepuram TAMIL NADU Kancheepuram TAMIL NADU
Kancheepuram
TAMIL NADU |
9669450181
aishwarya.gurus1994@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institute Human Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: N70-N77||Inflammatory diseases of female pelvic organs, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Bupivacaine |
Before the beginning of surgery,0.5% Bupivacaine 20ml ( 100mg ) given epidurally one time 15 minutes before incision |
| Comparator Agent |
Magnesium sulphate |
Before the beginning of surgery, 0.5ml magnesium sulphate ( 500mg ) along with 0.5% Bupivacaine 20ml ( 100mg ) given epidurally one time before 15 minutes start of incision |
|
|
Inclusion Criteria
|
| Age From |
40.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Female |
| Details |
Patients undergoing total abdominal hysterectomy surgery.
Patients in the age group 40-60 years.
ASA I & II female |
|
| ExclusionCriteria |
| Details |
Patient refusal.
Allergy to local anesthetics/magnesium sulphate
ASA III & ASA IV
Coagulation disorders.
Local site infection.
BMI > 30.
Poorly controlled Hypertension.
Poorly controlled Diabetes mellitus.
Severe CVS abnormalities
Renal or Hepatic failure.
CVS disorders like heart block,myocardial infraction
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To compare the duration of analgesia of epidural block with plain Bupivacaine and Bupivacaine with Magnesium sulphate in patients undergoing total abdominal hysterectomy |
Post operative period |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Onset of action
Intra op requirement of analgesia
Side effect-shivering, pruritis, hypotension
|
Intra operative period and post operative period |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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 1 |
|
Date of First Enrollment (India)
|
10/02/2020 |
| 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
|
Not Yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
Brief Summary
Modification(s)
|
This is aprospective randomised controlled trial to compare the plain bupivacaine with and without magnesium sulphate given through epidural catheter for patient undergoing total abdominal hysterectomy,among 60 patients are divided in to 2 groups over a period of 18 months.The primary objective is to compare the duration of analgesia between 2 groups.The secondary objectives are onset of action, intra operative requirement of analgesia,looking for side effects like shivering, pruritis , hypotension intra operatively. |