| CTRI Number |
CTRI/2022/07/043635 [Registered on: 01/07/2022] Trial Registered Prospectively |
| Last Modified On: |
08/07/2022 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
compare the after surgery pain prevention effect of two different doses of drug |
|
Scientific Title of Study
|
To Compare The Post Operative Analgesic effect Of Two Different Doses Of Magnesium Sulphate As An Adjuvant To Levobupivacaine In Sub-Arachnoid Block for Infra-Umbilical Surgeries |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Lakshmi Mahajan |
| Designation |
Associate Professor |
| Affiliation |
Sri Guru Ram Das Institute of Medical Sciences and Research |
| Address |
Operation Theatre, Sri Guru Ram Das Institute of Medical Sciences and Research, Sri Amritsar.
Amritsar
PUNJAB
143001
India |
| Phone |
7986469143 |
| Fax |
|
| Email |
drlakshmimahajan@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sunil Chawla |
| Designation |
Professor |
| Affiliation |
Sri Guru Ram Das Institute of Medical Sciences and Research |
| Address |
Sri Guru Ram Das Institute of Medical Sciences and Research, Sri Amritsar.
Sri Guru Ram Das Institute of Medical Sciences and Research, Sri Amritsar.
Amritsar
PUNJAB
143001
India |
| Phone |
9915530033 |
| Fax |
|
| Email |
sunilchawla30@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Kanwarvir Singh |
| Designation |
Junior Resident |
| Affiliation |
SGRDIMSAR |
| Address |
Operation Theatre, Sri Guru Ram Das Institute of Medical Sciences and Research, Sri Amritsar.
Amritsar
PUNJAB
143001
India |
| Phone |
9729324360 |
| Fax |
|
| Email |
hirakanwar@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
SGRDIMSAR |
| Address |
Mehta Road, Vallah |
| Type of Sponsor |
Research institution and hospital |
|
|
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 Ruchi Gupta |
SGRD Hospital |
Department of Anaesthesia,
SGRDIMSAR
Amritsar
PUNJAB |
9814320805
drruchisgrd@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| SGRD ethical committe |
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 |
Magnesium sulphate |
Compare two different doses of magnesium sulphate and normal saline |
| Intervention |
Spinal Anaesthesia |
group A:0.5% Isobaric LEVOBUPIVACAINE 15mg+100mg magnesium sulphate diluted in N.S(0.2ml),
group B: 0.5% isobaric LEVOBUPIVACAINE 15mg+75mgmagnesium sulphate diluted in N.S. (0.2 ml)and
group C: only isobaric LEVOBUPIVACAINE 0.5%+0.2ML(NS) intrathecally. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Patients undergoing infra-umbilical surgeries
American Society of Anesthesiology (ASA) Grade I and II
Hemodyanamically stable
|
|
| ExclusionCriteria |
| Details |
1. Neurological and musculoskeletal disease.
2. Patients with cardiovascular diseases.
3. Contraindications to regional anesthesia such as patient refusal, local infections/sepsis at the site of lumbar puncture, anatomical disorders of spine, shock, any bleeding disorder and patient on anticoagulants.
4. Hypersensitivity to study drugs
5. Pregnant women
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To Compare Post Operative Analgesic effect of Two Different Doses of Magnesium Sulphate as an Adjuvant to Levobupivacaine in Sub-Arachnoid Block for Infra-Umbilical Surgeries |
from the time of giving spinal anaesthesia till 24 hours postopertively |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Complications |
from the time of giving spinal anaesthesia till 24 hours postopertively |
|
|
Target Sample Size
|
Total Sample Size="90"
Sample Size from India="90"
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)
|
02/07/2022 |
| 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
Modification(s)
|
Years="0"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
NA |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Hyperbaric bupivacaine 0.5% iscommonly used in spinal
anesthesia. Hyperbaric solutions may cause sudden cardiac arrest due to
hypotension, bradycardia because of higher extend of sympathetic blockade. The
use of isobaric solutions may decrease these risks. LEVOBUPIVACAINE is newer
drug and should be preferred during
spinal anesthesia due to its lower cardiovascular side-effects and central
nervous system toxicity. Intrathecal adjuvants are commonly used to improve the
quality of intraoperative analgesia and extend it in the postoperative period
without significant motor or autonomic blockade.
The
study will consist of 90 patients randomly divided into three groups of 30
each- group A:0.5% Isobaric LEVOBUPIVACAINE
15mg + 100mg magnesium sulphate diluted in N.S(0.2ml),
group B: 0.5% isobaric LEVOBUPIVACAINE 15mg +75mgmagnesium sulphate diluted in
N.S. (0.2 ml)and group C: only isobaric LEVOBUPIVACAINE 0.5%+0.2ML(NS)
intrathecally. These groups will be compared with respect to onset and duration
of sensory and motor blockade, duration of postoperative analgesia, sedation
score, side effects and complications. |