| CTRI Number |
CTRI/2023/07/055582 [Registered on: 24/07/2023] Trial Registered Prospectively |
| Last Modified On: |
24/07/2023 |
| 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 effectiveness of intravenous magnesium sulphate and paracetamol in reducing the pain after surgery in patients undergoing Total abdominal hysterectomy |
|
Scientific Title of Study
|
A comparison of post operative analgesia of magnesium sulphate to paracetamol intravenously in patients undergoing total abdominal hysterectomy under subarachnoid block in tertiary care center in kerala |
| Trial Acronym |
nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
ANU ELSA BOBBY |
| Designation |
Postgraduate resident |
| Affiliation |
pushpagiri medical college and research centre thiruvalla |
| Address |
Pushpagiri Medical College and Research Centre
Thiruvalla
Pathanamthitta
Pathanamthitta
KERALA
689101
India |
| Phone |
8111952093 |
| Fax |
|
| Email |
anuelsa96@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr. Mathews K Thomas |
| Designation |
Associate Professor |
| Affiliation |
pushpagiri medical college and research centre thiruvalla |
| Address |
Pushpagiri Medical College and Research Centre
Thiruvalla
Pathanamthitta
Pathanamthitta
KERALA
689101
India |
| Phone |
7356879388 |
| Fax |
|
| Email |
mathewskthomas@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
ANU ELSA BOBBY |
| Designation |
Post graduate resident |
| Affiliation |
pushpagiri medical college and research centre thiruvalla |
| Address |
Pushpagiri Medical College and Research Centre
Thiruvalla
Pathanamthitta
Pathanamthitta
KERALA
689101
India |
| Phone |
8111952093 |
| Fax |
|
| Email |
anuelsa96@gmail.com |
|
|
Source of Monetary or Material Support
|
| Pushpagiri Medical College and Research Institute
Thiruvalla |
|
|
Primary Sponsor
|
| Name |
ANU ELSA BOBBY |
| Address |
Pushpagiri medical college and research centre, Thiruvalla
Pathanamthitta |
| Type of Sponsor |
Other [] |
|
|
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 ANU ELSA BOBBY |
Pushpagiri Medical College and Research Centre |
Department of Anaesthesiology
Pushpagiri Medical College
Thiruvalla
Pathanamthitta
KERALA |
8111952093
anuelsa96@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| pushpagiri institute of medical science and research centre |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: N939||Abnormal uterine and vaginal bleeding, unspecified, (2) ICD-10 Condition: N926||Irregular menstruation, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Comparing the post operative analgesic effect of intravenous Magnesium sulphate and Paracetamol in patients undergoing total abdominal hysterectomy under Sub arachnoid block |
patients are divided into two groups. One group will receive intravenous magnesium sulphate 30 mg/kg for 15 minutes and then 15mg/kg/hour until 4 grams is reached. Other group will receive paracetamol 1 gram intravenous infusion. The post operative analgesic requirement is monitored for 24 hours post operative
patients are monitored for the 24 hour cumulative analgesic requirement
monitor for adverse effects of magnesium sulphate |
| Comparator Agent |
comparing the post operative analgesic effect of magnesium sulphate to paracetamol in patients undergoing total abdominal hysterectomy under sub arachnoid block. |
In this study 1 gram paracetamol is administered as the comparator agent after giving sub arachnoid block for total abdominal hysterectomy. |
|
|
Inclusion Criteria
|
| Age From |
30.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Female |
| Details |
1.ASA grade 1 and 2 patients
|
|
| ExclusionCriteria |
| Details |
1.Emergency surgeries
2.BMI > 40kg/m2
3.Patients with known allergy to the drugs used in study
4.Patients with renal insufficiency
5.Neuromuscular diseases
6.Hepatic dysfunction
7.Cardiac disease
8.Previous oncological surgery
|
|
|
Method of Generating Random Sequence
|
|
|
Method of Concealment
|
|
|
Blinding/Masking
|
|
|
Primary Outcome
|
| Outcome |
TimePoints |
| Pain score in both the group |
0hr, 4hr, 8 hr, 12hr , 16hr, 20 hr , 24hr |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
•Total analgesic requirement in the two groups in first 24 hours
•Time (in minutes) to request first analgesic in both groups
•Frequency of occurrence of side-effects of magnesium sulphate |
0 hour, 4 hours, 8 hours , 12 hours , 16 hours, 20 hours, 24 hours |
|
|
Target Sample Size
|
Total Sample Size="39"
Sample Size from India="39"
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 4 |
|
Date of First Enrollment (India)
|
03/08/2023 |
| 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)?
Response - NO
|
|
Brief Summary
|
This is a study to compare the post operative analgesic effect of intravenous magnesium sulphate and paracetamol in patients undergoing total abdominal hysterectomy under Sub arachnoid block. This surgery is associated with severe post operative pain and patients require analgesics including opioids. This study is conducted to find out if the analgesic requirement has reduced in patients receiving these drugs. |