| CTRI Number |
CTRI/2020/12/029820 [Registered on: 15/12/2020] Trial Registered Prospectively |
| Last Modified On: |
11/12/2020 |
| 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
|
Testing drugs for better pain relief in breast ontological studies |
|
Scientific Title of Study
|
To Compare The Post operative Analgesia with epidural ropivacaine with or without ketamine vs magnesium sulphate for breast ontological 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 Sunil Chawla |
| Designation |
Professor |
| Affiliation |
Sr guru ram das institute of medical sciences and research |
| Address |
Department of Anaesthesia,
Sri Guru Ram Das Institute of
Medical Sciences and Research,
Sri Amritsar
vallah amritsar
Amritsar
PUNJAB
143001
India |
| Phone |
|
| Fax |
|
| Email |
drchawla30@yahoo.co.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Ruchi Gupta |
| Designation |
Professor amd head |
| Affiliation |
Sri guru ram das institute of medical sciences and research |
| Address |
Department of Anaesthesia,
Sri Guru Ram Das Institute of
Medical Sciences and Research,
Sri Amritsar
vallah amritsar
Amritsar
PUNJAB
143001
India |
| Phone |
|
| Fax |
|
| Email |
drruchisgrd@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Rubinder kaur |
| Designation |
Pg, j.r |
| Affiliation |
Sr guru ram das institute of medical sciences and research |
| Address |
Department of Anaesthesia,
Sri Guru Ram Das Institute of
Medical Sciences and Research,
Sri Amritsar
vallah amritsar
Amritsar
PUNJAB
143001
India |
| Phone |
|
| Fax |
|
| Email |
maniksehgal2001@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of anesthesia, guru ram das medical college amritsar.vallah |
|
|
Primary Sponsor
|
| Name |
Sri guru ram das medical college |
| Address |
vallah amritsar |
| 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 |
| Rubinder kaur |
Sri guru ram das institute of medical sciences and research |
Department of anesthesia.
Amritsar
PUNJAB |
9816615551
maniksehgal2001@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Sgrdimsr |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: C509||Malignant neoplasm of breast of unspecified site, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Magnesium |
6 ml of 0.75% ropivacaine with 1 mg/kg magnesium sulphate through epidural route to make final volume of 8 ml using normal saline |
| Intervention |
Ropivacaine |
ml of 0.75% ropivacaine with 0.5mg/kg ketamine through epidural route to make final volume of 8 ml using saline |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Female |
| Details |
Female patients aged 20-70 yrs. with ASA grade I and II scheduled for elective Carcinoma breast surgeries.
2.Patients giving consent for the study.
|
|
| ExclusionCriteria |
| Details |
Contraindications to epidural anaesthesia: Patients with spinal deformity, local infection, unstable hemodynamics, bleeding diathesis and on anticoagulants.
2. Contraindication to study drug: Allergy, hypersensitivity, mental retardation, drug abuse, cardiac, respiratory, renal, thyroid, hepatic and CNS disorder.
|
|
|
Method of Generating Random Sequence
|
Adaptive randomization, such as minimization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| evaluate twenty four hour postoperative analgesic efficacy of magnesium sulphate 1mg/kg vs ketamine 0.5 mg/kg as adjunct to epidural ropivacaine alone in patients undergoing breast oncological surgery. |
On arrival in the recovery room, time will be counted as 0 hours and the patient will be evaluated for vitals, pain, side effects every 30 minutes for next 2 hours and later at 4, 6, 8, 10, 12, 24 hrs. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Efficacy of Magnesium as adjunct to Ropivacaine on intensity of post operative pain using Numerical Rating Score.
2)Efficacy of Ketamine as adjunct to Ropivacaine on intensity of post operative pain using Numerical Rating Score.
3)Comparison the efficacy of ketamine and magnesium on intensity of post operative pain using NRS.
|
On arrival in the recovery room, time will be counted as 0 hours and the patient will be evaluated for vitals, pain, side effects every 30 minutes for next 2 hours and later at 4, 6, 8, 10, 12, 24 hrs. |
|
|
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 1 |
|
Date of First Enrollment (India)
|
24/12/2020 |
| 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="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| 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
|
Due to incorporation of ketamine in schedule h its availability is a concern.so to evaluate newer drugs in post operative nalgesiq during breast oncologicql surgeries we decided to compare epidural ropivacaine with ot without magneisum sulphate with ketamine |