| CTRI Number |
CTRI/2022/09/046071 [Registered on: 30/09/2022] Trial Registered Prospectively |
| Last Modified On: |
13/09/2022 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cohort Study |
| Study Design |
Other |
|
Public Title of Study
|
effect of stress (before operation) on pain and improvement after operation in surgery for breast cancer |
|
Scientific Title of Study
|
Effect of preoperative anxiety on postoperative pain and quality of recovery after modified radical mastectomy |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Ankhila Dattatray Hamand |
| Designation |
Junior Resident first year |
| Affiliation |
Department of Anaesthesia Lokmanya Tilak municipal medical college hospital |
| Address |
lokmanya tilak municipal medical college and hospital sion ,mumbai
Mumbai
MAHARASHTRA
400022
India |
| Phone |
9321806977 |
| Fax |
|
| Email |
hamandankhila22@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Preeti Rustagi |
| Designation |
Associate Professor |
| Affiliation |
Department of Anaesthesia,Lokmanya Tilak municipal medical college hospital |
| Address |
lokmanya tilak municipal medical college and hospital sion ,mumbai
Mumbai
MAHARASHTRA
400022
India |
| Phone |
9769215359 |
| Fax |
|
| Email |
drpreetirustagi@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Ankhila Dattatray Hamand |
| Designation |
Junior Resident first year |
| Affiliation |
Lokmanya Tilak municipal medical college hospital |
| Address |
lokmanya tilak municipal medical college and hospital sion ,mumbai
Mumbai
MAHARASHTRA
400022
India |
| Phone |
9321806977 |
| Fax |
|
| Email |
hamandankhila22@gmail.com |
|
|
Source of Monetary or Material Support
|
| Lokmanya tilak muncipal and medical college,mumai |
|
|
Primary Sponsor
|
| Name |
Lokmanya tilak municipal medical college |
| Address |
LOkmanya tilak municipal medical college,sion ,mumbai |
| 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 Ankhila Hamand |
lokmanya tilak municipal medical college & hospital |
Surgery ot,ward building ,3rd floor.
Mumbai
MAHARASHTRA |
9321806977
hamandankhila22@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethics committee lokmanya tilak municipal medical college. |
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
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Female |
| Details |
female patients undergoing modeified radical mastectomy, between 18 years to 65 years of ASA CLASS | and ‖. |
|
| ExclusionCriteria |
| Details |
patients 1 Ot giving consent
2 With chronic pain
3 With chronic non steroidal anti
inflammatory drugs/opoid use
4 With psychiatric illness |
|
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Method of Generating Random Sequence
|
|
|
Method of Concealment
|
|
|
Blinding/Masking
|
|
|
Primary Outcome
|
| Outcome |
TimePoints |
| Relationship between preoperative anxiety and postoperative pain. |
Assessment of anxiety with APAIS(Amsterdam preoperative anxiety and information scale) one day prior and postoperative pain with Visual Analogue scale at 2nd,4th,8th ,12th and 24th hours. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Analyze the effect of preoperative anxiety on postoperative analgesic
consumption after surgery
(MRM)
Analyze effect of preoperative anxiety on recovery by Quality of recovery -15 questionnaire.
Analyze the effect of preoperative anxiety on quality of recovery after surgery(MRM) |
2,4,8, 12, 24 hours after surgery |
|
|
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)
|
30/10/2022 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
13/10/2022 |
| 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 Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
|
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Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
After satisfying all inclusion and exclusion criteria and written valid consent taken ,one day prior to operation patient’s anxiety will be assessed using APAIS scale .Question will be translated to local language .Surgery will be performed under general anesthesia with intraoperative pain management including injection fentanyl and dexmedetomidine .All patient’s are administered injection paracetamol 30 minute prior to extubation for postoperative pain relief .Total dose of intraoperative pain relievers will be recorded .Then postoperative pain severity will be measured using VAS scale quality of recovery will be assessed .scale and depend on scale score ,if VAS score >3 injection tramadol 1mg/kg administered intravenously as rescue analgesic and patient will be observed if further doses required total dose of tramadol .Then 24hours postoperatively QOR15 will be used to asses quality of recovery and depend on QOR15 |