| 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
|
|
|
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
|
|
|
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 |
|
|
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. |