| CTRI Number |
CTRI/2024/01/062168 [Registered on: 31/01/2024] Trial Registered Prospectively |
| Last Modified On: |
31/01/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
To evaluate the effect of intravenous vitamin B12 on chronic post surgical pain after modified radical mastectomy |
|
Scientific Title of Study
|
Effect of perioperative intravenous vitamin B12 on chronic post surgical pain after modified radical mastectomy:A prospective randomiized double blind control 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 |
Dr P Hemalatha |
| Designation |
Professor ,Department of Anaesthesiology,SVIMS |
| Affiliation |
|
| Address |
Department of Anaesthesiology, SVIMS, Alipiri, Tirupati, Chittoor,Andhra Pradesh,517507
Chittoor
ANDHRA PRADESH
517507
India |
| Phone |
9490713983 |
| Fax |
|
| Email |
madhugastro@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr P Hemalatha |
| Designation |
Professor, Department of Anaesthesiology, SVIMS |
| Affiliation |
Sri Venkateswara Institute of Medical Sciences |
| Address |
Department of Anaesthesiology, SVIMS,Alipiri,Tirupati,Chittoor,Andhra Pradesh,517507 Chittoor
ANDHRA PRADESH
517507
India
Chittoor
ANDHRA PRADESH
517507
India |
| Phone |
9490713983 |
| Fax |
|
| Email |
madhugastro@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr P Hemalatha |
| Designation |
Professor, Department of Anaesthesiology, SVIMS |
| Affiliation |
Sri Venkateswara Institute of Medical Sciences |
| Address |
Department of Anaesthesiology, SVIMS,Alipiri,Tirupati,Chittoor,Andhra Pradesh,517507 Chittoor
ANDHRA PRADESH
517507
India
Chittoor
ANDHRA PRADESH
517507
India |
| Phone |
9490713983 |
| Fax |
|
| Email |
madhugastro@gmail.com |
|
|
Source of Monetary or Material Support
|
| Sri Venkateswara Institute of Medical Sciences, Alipiri road,Tirupati,Chittoor,Andhra pradesh 517507
|
|
|
Primary Sponsor
|
| Name |
Nil |
| Address |
Nil |
| Type of Sponsor |
Other [Nil] |
|
|
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 P Hemalatha |
SRI VENKATESWARA INSTITUTE OF MEDICAL SCIENCES |
DEPARTMENT OF ANAESTHESIOLOGY, SVIMS, ALIPIRI ROAD, TIRUPATI, CHITTOOR, ANDHRAPRADESH - 517507
Chittoor
ANDHRA PRADESH |
9490713983
madhugastro@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee |
Submittted/Under Review |
|
|
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 |
100 ml of normal saline 1 hour before surgery |
100 ml of normal saline 1 hour before surgery and on POD 1 and 2 |
| Intervention |
perioperative intravenous vitamin B12 500mcg on the day of surgery and on POD 1 and 2 |
500mcg of vitamin B12 in 100ml of normal saline given 1 hour before surgery and on POD 1 AND 2 |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
patients with ASA physical status 1,2,3
patients posted for elective modified radical mastectomy |
|
| ExclusionCriteria |
| Details |
patients who are not willing to participate in study
patients with pre existing pain syndromes
patients with cardiovascular,pulmonary,renal and hepatic disease
patients not able to communicate and understand NRS scoring
patients with known allergy to study drug
pregnant and lactating women |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To evaluate the effect of peri operative intra venous vitamin B12 on the incidence of chronic post mastectomypain at 3rd month |
To evaluate the effect of peri operative intra venous vitamin B12 on the incidence of chronic post mastectomypain at 3rd month |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To assess the severity of chronic post mastectomy pain using Numerical Rating Scale(NRS) |
After 3 months |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
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
|
N/A |
|
Date of First Enrollment (India)
|
06/01/2025 |
| 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
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
This is a randomised double blind control study conducted in India to evaluate the efficacy of intravenous vitamin B12 500mcg in 500ml normal saline on the day of surgery and on POD1 and 2 on reduction of chronic post surgical pain in patients undergoing modified radical mastectomy.After 3 months of surgery patients are contacted through telephone and pain will be assessed by Numerical Rating Scale(1-10) |