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CTRI Number  CTRI/2024/05/067888 [Registered on: 24/05/2024] Trial Registered Prospectively
Last Modified On: 15/05/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Randomized, Parallel Group, Placebo Controlled Trial 
Public Title of Study   low dose ketamine for pain relief in CA breast patients for breast cancer surgery 
Scientific Title of Study   Impact of intraoperative and post operative low dose ketamine infusion on neuropathic pain component in chronic persistent postsurgical pain following breast cancer surgery . A randomized controlled double blind 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  Rajat Singh 
Designation  Post graduate student 
Affiliation  University College of Medical Sciences/Guru Tegh Bahadur Hospital 
Address  Department of Anaesthesia Second floor near Main icu UCMS Shahdara Delhi

East
DELHI
110095
India 
Phone  9634389359  
Fax    
Email  rajat.ranasingh123@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Ashok Kumar 
Designation  Professor and Ex-Head of Department  
Affiliation  University College of Medical Sciences/Guru Tegh Bahadur Hospital 
Address  Department of Anaesthesia Second floor near Main icu UCMS Shahdara Delhi


DELHI
110095
India 
Phone  9810431367  
Fax    
Email  profashoksaxena2@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Rajat Singh 
Designation  Post graduate student 
Affiliation  University College of Medical Sciences/Guru Tegh Bahadur Hospital 
Address  Department of Anaesthesia Second floor near Main icu UCMS Shahdara Delhi


DELHI
110095
India 
Phone  9634389359  
Fax    
Email  rajat.ranasingh123@gmail.com  
 
Source of Monetary or Material Support  
Nil 
University College of Medical Sciences, Shahdara, Delhi-110095, India 
 
Primary Sponsor  
Name  University College Of Medical Sciences 
Address  Shahdara, Delhi-110095 , India. 
Type of Sponsor  Government medical college 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Rajat Singh  Department of Anaesthesia, Second Floor, MAIN ICU, GTB HOSPITAL   Dilshad Garden/GTB hospital
East
DELHI 
9634389359

rajat.ranasingh123@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional ethics committee- Human Research, University College of Medical Sciences  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
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  Group C- Normal saline  Control group in which patients received 0.4 mg/kg normal saline intravenous as a bolus before skin incision followed by intraoperative and immediate postoperative normal saline intravenous infusion for 24 hours @ 0.2mg/kg/hr. 
Intervention  Group S-Injection Ketamine  Study group in which patients received 0.4mg/kg ketamine intravenous as bolus before skin incision followed by intraoperative and immediate postoperative intravenous infusion for 24 hours @ 0.2mg/kg/hr. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Female 
Details  Adult female patients between 18-65 year of age, who are diagnosed as carcinoma breast and scheduled to undergo elective breast cancer surgery 
 
ExclusionCriteria 
Details   
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Double Blind Double Dummy 
Primary Outcome  
Outcome  TimePoints 
To assess and compare NRS-Pain scores and neuropathic pai. n in the study group S as compared to similar scores in control group C following breast cancer surgery at 1hour, 6 hours, 24 hours, 72 hours, 1 month, 2months and 3 months post-breast cancer surgery.  To assess and compare NRS-Pain scores and neuropathic pain in the study group S as compared to similar scores in control group C following breast cancer surgery at 1hour, 6 hours, 24 hours, 72 hours, 1 month, 2months and 3 months post-breast cancer surgery. 
 
Secondary Outcome  
Outcome  TimePoints 
To assess and compare rescue analgesia required in the study group S as compared to control group C following breast cancer surgery.
To assess and compare SF12 scores in the study group S as compared to control group C following breast cancer surgery.
3To assess and compare adverse effects in the study group S as compared to control group C following breast cancer surgery.

 
1,6,24,72 hours
1,2,3 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   Phase 4 
Date of First Enrollment (India)   30/05/2024 
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="4"
Days="0" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
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  

Rationale: Chronic persistent post-surgical pain is a debilitating complication following breast cancer surgery. Therefore, it is important to evolve strategies that limit the development of chronic persistent post-surgical pain.

Objectives: To assess and compare NRS pain scores, multiple neuropathic pain scores (DN4, NPSI, PDQ scores), rescue analgesia, SF-12 Quality of Life scores and adverse effects in the study group as compared to similar scores in control group following breast cancer surgery.

Study design: Randomised, controlled, double blind study.

Time frame: Study will be conducted from March 2024 to August 2026.

Participants: Adult female patients aged 18 to 65 years of age, diagnosed as carcinoma breast scheduled for elective breast cancer surgery.

Procedure: Patients will be randomly divided into two groups of 30 patients in each group. Study group will receive ketamine as a bolus before skin incision followed by low dose ketamine infusion intraoperatively and postoperatively for 24 hours whereas we will use normal saline in control group in same dosing and time period as study group.

Patients will be assessed for NRS-pain score and multiple neuropathic scores (DN4, NPSI, PDQ scores) at 1hour, 6 hours, 24 hours, 72 hours, 1 month, 2 months and 3 months post-breast cancer surgery.

Outcome measures: NRS-pain scores, DN4 questionnaire score, NPSI score, PDQ score, SF-12 quality of life scores, rescue analgesia required and adverse events will be assessed and compared between study group and control group.

Sample size: One hundred adult female patients diagnosed a carcinoma breast.

But because of limitations in the availability of cases of carcinoma breast in our clinical setup for breast cancer surgery, we shall be taking up 30 patients per arm; though every effort would be made to target calculated value of patients per arm.

Statistical analysis: Data will be analysed by SPSS statistical software version 20. The data will be summarised for continuous variable in mean (SD) or median (25th to 75th percentile) and qualitative data will be reported with number and percentage.

Baseline patient characteristics will be compared using unpaired t-test and “Chi-square test” using two arms. All continuous variables will be tested for normality using box whisker plot and Kolmogorov Smirnov test.Level of significance for present studywill be fixed as 5 % or p< 0.05.

 
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