| CTRI Number |
CTRI/2022/02/040012 [Registered on: 03/02/2022] Trial Registered Prospectively |
| Last Modified On: |
02/02/2022 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A CLINICAL TRAIL TO STUDY COMPARISON BETWEEN ROPIVACAINE WITH OR WITHOUT MAGNESIUM SULPHATE FOR POST OPERATIVE PAIN RELIEF IN LOWER ABDOMINAL SURGERY BY USING TRANSVERSUS ABDOMINIS PLANE BLOCK |
|
Scientific Title of Study
|
A COMPARATIVE STUDY BETWEEN ROPIVACAINE WITH OR WITHOUT MAGNESIUM SULPHATE FOR POST OPERATIVE ANALGESIA IN LOWER ABDOMINAL SURGERY BY USING TRANSVERSUS ABDOMINIS PLANE BLOCK |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Abhinetri Danashetti |
| Designation |
PostGraduate Resident |
| Affiliation |
HKE Societys M R Medical College |
| Address |
Departement Of Anaesthesia, Basaveshwar Teaching And General Hospital , Gulbarga
Gulbarga
KARNATAKA
585105
India |
| Phone |
9481983493 |
| Fax |
|
| Email |
abhinetridanashetti1994@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr M R Sontakke Nanda Nandyal |
| Designation |
Associate Professor |
| Affiliation |
HKE Societys M R Medical College |
| Address |
Department Of Anaesthesia
Basaveshwar Teaching And General Hospital
Gulbarga
Gulbarga
KARNATAKA
585105
India |
| Phone |
9663420776 |
| Fax |
|
| Email |
nandyalnanda@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Abhinetri Danashetti |
| Designation |
PostGraduate Resident |
| Affiliation |
HKE Societys M R Medical College |
| Address |
Department Of Anaesthesia, Basaveshwar Teaching and General Hospital , Gulbarga
Gulbarga
KARNATAKA
585105
India |
| Phone |
9481983493 |
| Fax |
|
| Email |
abhinetridanashetti1994@gmail.com |
|
|
Source of Monetary or Material Support
|
| Basaveshwar Teaching and General Hospital |
|
|
Primary Sponsor
|
| Name |
Dr Abhinetri Danashetti |
| Address |
B.V.V Sanghas Staff Quaters No. 6, Near Commerce College, Bagalkot 587101 |
| 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 Abhinetri Danashetti |
Basaveshwar Teaching and General Hospital |
Dept. Of Anaesthesia,Sedam Road, Kalaburgi 585105
Gulbarga
KARNATAKA |
9481983493
abhinetridanashetti1994@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| HKE Societys Mahadevappa Rampure Medical College Institutional Ethics Committee |
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 |
Ropivacaine + Magnesium Sulphate
Dose- Inj. Ropivacaine 0.25% Of 20ml With 2.5ml Of 20% Magnesium Sulfate (500mg) For 8-10hours |
| Intervention |
Nil |
Nil |
| Comparator Agent |
Ropivacaine |
Dose-Inj. Ropivacaine 0.25% Of 20ml With 2.5ml Of Normal Saline for 6-8hours
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1.All patients posted for lower abdominal surgery.
2.Age group 18-60 years.
3.Patients of American Society of Anaesthesiology grade 1 and II.
|
|
| ExclusionCriteria |
| Details |
1. Patients on any opioid or any sedative medication in the week prior to the surgery.
2. Patients with history of alcohol or drug abuse.
3. Patients who have known allergies to any of test drugs.
4. Patients with coagulation disorders or on anti coagulant drugs.
5. Patients with cardiac disease (heart block, premature ventricular contractions, significant bradyarrhythmias, left ventricular failure.)
6. Patients with respiratory diseases.
|
|
|
Method of Generating Random Sequence
|
Adaptive randomization, such as minimization |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To study the efficacy of Ropivacaine with or without Magnesium sulphate for postoperative analgesia. |
From Time of Injection to First 6-8 Hours After The Surgery |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To Study Systemic Side Effects. |
From Time Of Injection To 6hr, 12hr, 24hr After The Surgery |
|
|
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 3/ Phase 4 |
|
Date of First Enrollment (India)
|
04/02/2022 |
| 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
|
Years="1"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
Nil |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
This Study Is a Prospective Interventional Study, With Duration Of 18Months
And Sample Size Of 60 Patients divided into two groups GroupA and Group B with 30 patients each
Sampling procedure:Simple Random sampling GroupA-30case Inj .Ropivocaine 0.25% 20ml with 2.5ml of Normal saline GroupB-30cases Inj Ropivocaine 0.25% 20ml With 2.5ml of Magnesium Sulphate(500mg) conducted in our Institution and Research Hospital. Primary outcome will be to provide Post operative analgesia after lower abdominal surgeries using TAP Block
|