| CTRI Number |
CTRI/2026/03/105204 [Registered on: 02/03/2026] Trial Registered Prospectively |
| Last Modified On: |
28/02/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A Study on Different Doses of Magnesium for Improving Pain Relief After Abdominal Hysterectomy |
|
Scientific Title of Study
|
COMPARISION OF DIFFERENT DOSES OF MAGNESIUM SULPHATE AS AN ADJUVANT TO LEVOBUPIVACAINE IN ULTRASOUND GUIDED TRANSVERSUS ABDOMINIS PLANE BLOCK IN PATIENTS UNDERGOING TOTAL ABDOMINAL HYSTERECTOMY UNDER SPINAL ANAESTHESIA: A PROSPECTIVE RANDOMISED STUDY |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Harshith ananth |
| Designation |
Post Graduate |
| Affiliation |
Rajarajeswari Medical College And Hospital |
| Address |
Department of Anaesthesiology, Rajarajeswari Medical college and
Hospital,Mysore road,kambipura,Bangalore
Bangalore
KARNATAKA
560074
India
Bangalore
KARNATAKA
560074
India |
| Phone |
9740867171 |
| Fax |
|
| Email |
harshithananth123@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sudheer R |
| Designation |
Professor |
| Affiliation |
Rajarajeswari Medical College And Hospital |
| Address |
Department of Anaesthesiology, Rajarajeswari Medical college and
Hospital,Mysore road,kambipura,Bangalore
Bangalore
Bangalore
KARNATAKA
560074
India |
| Phone |
9741117754 |
| Fax |
|
| Email |
sudheer_mys@yahoo.co.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sudheer R |
| Designation |
Professor |
| Affiliation |
Rajarajeswari Medical College And Hospital |
| Address |
Department of Anaesthesiology, Rajarajeswari Medical college and
Hospital,Mysore road,kambipura,Bangalore
Bangalore
Bangalore
KARNATAKA
560074
India |
| Phone |
9741117754 |
| Fax |
|
| Email |
sudheer_mys@yahoo.co.in |
|
|
Source of Monetary or Material Support
|
| Rajarajeswari Medical College and Hospital,Mysore Road,Kambipura,Bangalore Bangalore
KARNATAKA 560074 India |
|
|
Primary Sponsor
|
| Name |
Harshith Ananth |
| Address |
Rajarajeswari Medical College and Hospital,Mysore
Road,Kambipura,Bangalore Bangalore KARNATAKA 560074 India |
| 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 |
| Dr Harshith Ananth |
Rajarajeswari medical college and hospital |
2nd floor hospital
building,department of
Anaesthesiology,Rajara
jeswari medical college
and hospital,kambipura
Bangalore
KARNATAKA
Bangalore
KARNATAKA |
9740867171
harshithananth123@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee , Rajarajeswari Medical college and Hospital |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O00-O9A||Pregnancy, childbirth and the puerperium, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Group A |
USG guided transversus abdominis plane block with 20 ml of 0.25% Levobupivacaine with 150mg of Magnesium Sulphate Constituted in 3ml of Normal Saline on either side.
|
| Comparator Agent |
Group B |
USG guided transversus abdominis plane block with 20 ml of 0.25% Levobupivacaine with 250mg of Magnesium Sulphate Constituted in 3ml of Normal Saline on either side. |
|
|
Inclusion Criteria
|
| Age From |
45.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Female |
| Details |
Undergoing Total abdominal hysterectomy (TAH) under spinal anesthesia
|
|
| ExclusionCriteria |
| Details |
1.Patient refusal.
2.Patients belonging to ASA 3 and above
3.Patients having history of allergy to local anaesthetics.
4.Patient with bleeding diathesis/deranged coagulation profile
5.Patient suffering from neurological and psychiatric disorders.
6.Patient having spine abnormalities.
7.Local site infection.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
To compare VAS scores between both the groups in the post operative period.
|
To compare VAS scores between both the groups at 0min,30min,1hr,2hrs,4hrs,6hrs,8hrs ,16hrs and 24hrs
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1.Number of doses of rescue analgesic used
2.Time to first rescue analgesic
3.Time taken for regression of sensory level up to T8 dermatome
4.Adverse effects if any.
|
Time of first rescue analgesia within first 24 hours |
|
|
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 2/ Phase 3 |
|
Date of First Enrollment (India)
|
15/03/2026 |
| 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="2"
Months="0"
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
|
This prospective randomized study aims to compare two different doses of magnesium sulphate as an adjuvant to levobupivacaine in ultrasound guided transversus abdominis plane block in patients undergoing total abdominal hysterectomy under spinal anaesthesia. Effective postoperative pain control is essential for better recovery and reduced analgesic requirement. |