Study of Pregabalin Effect on Post Surgical Pain on Breast Cancer Patients Underwent Axillary Dissection: a Double Blind Randomized Clinical Trial Using Placebo
Evaluating Pregabalin effect on post surgical patients who underwent breast cancer surgery
Design
Clinical trial with control group, Parallel groups, double blinded, randomized, phase 3, on 150 patients, Randomization was based on Random allocation software
Settings and conduct
Place: Shariati hospital and Imam Khomeini cancer institute
Procedure: Patients scheduled for breast surgery were given 75 mg pregabalin or placebo 1h before surgery and continued every 12 h for 15 days. Pain scores were obtained using Verbal numerical rating scale at specific times after surgery. Patients and researcher were blinded toward the drug. only pharmacotherapist knew the code of the drugs. it was revealed after data gathering.
Participants/Inclusion and exclusion criteria
Patients who underwent breast cancer surgery were enrolled in the study.
Patients who didn't sign the consent or with history of seizure or previously using pregabalin or GFR less than 60 or patients who were unable to cooperate with data gathering were excluded.
Intervention groups
Intervention group: 75 mg Pregabalin twice daily 15 days following surgery
control group: 75 mg Placebo twice daily 15 days following surgery
Main outcome variables
Age؛ BMI؛ Morphine usage؛ surgery time؛ tumor size؛ Lymph node involvement؛ Hospital؛ Nausea؛ headache؛ Dizziness؛ blurred vision؛ neoadjuvant؛ Breast surgery type؛ Axillary surgery type؛ Addiction؛ Point of maximal pain؛ Pain scores at rest and arm abduction in 24h, 48h, 1w, 1M and 6 month after surgery
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20200502047263N1
Registration date:2020-05-08, 1399/02/19
Registration timing:retrospective
Last update:2020-05-08, 1399/02/19
Update count:1
Registration date
2020-05-08, 1399/02/19
Registrant information
Name
Mohammad Masoomzadeh
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 31 3668 3368
Email address
mzmasoomzadeh@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-04-21, 1398/02/01
Expected recruitment end date
2019-09-22, 1398/06/31
Actual recruitment start date
2019-07-14, 1398/04/23
Actual recruitment end date
2019-10-02, 1398/07/10
Trial completion date
2020-03-29, 1399/01/10
Scientific title
Study of Pregabalin Effect on Post Surgical Pain on Breast Cancer Patients Underwent Axillary Dissection: a Double Blind Randomized Clinical Trial Using Placebo
Public title
Study of Pregabalin effect on breast cancer surgery
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients who underwent breast cancer surgery at Shariati hospital and Imam khomeini Cancer institute in 2019
Exclusion criteria:
Patient denial to participate in the study
Known cases with sensitivity to pregabalin
History of seizure
Patients who were already using Pregabalin or gabapentin or opioids
Patients who were unable to cooperate with data gathering, physically or emotionally
GFR less than 60
Age
No age limit
Gender
Female
Phase
3
Groups that have been masked
Participant
Care provider
Investigator
Sample size
Target sample size:
250
Actual sample size reached:
150
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization Method: Simple, each Patient has equal odds to be placed in intervention group or control group
Randomization unit: Each patient
No randomization layers was used
randomization tool: Random allocation software
Randomization sequence was created by software after defining each group and sample size
allocation concealment: central telephone randomization system, researcher telephone the pharmacotherapist and asks what group next patient will be.
Blinding (investigator's opinion)
Double blinded
Blinding description
Patients, Researcher, Doctors and nurses and Data gatherers were blind towards the drug. Evaluator and analyzer were not blind.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Tehran university of Medical Sciences
Street address
No 68, North Sindokht street, North Kargar Street, Tehran
City
Tehran
Province
Tehran
Postal code
1411933886
Approval date
2018-11-05, 1397/08/14
Ethics committee reference number
IR.TUMS.MEDICINE.REC.1397.570
Health conditions studied
1
Description of health condition studied
Post op Pain after breast cancer surgery
ICD-10 code
C50
ICD-10 code description
Malignant neoplasm of breast
Primary outcomes
1
Description
Post op pain score after breast cancer surgery
Timepoint
24h, 48h, 1w, 1m and 6 month after surgery
Method of measurement
Verbal Numerical Rating Scale (VNRS)
Secondary outcomes
1
Description
Morphine usage
Timepoint
after surgery until discharge
Method of measurement
nurse's report
Intervention groups
1
Description
Intervention group: 75 mg Pregabalin 1h before surgery orally then every 12h until 15 days after surgery
Category
Rehabilitation
2
Description
Control group: 75 mg Placebo 1h before surgery orally then every 12h until 15 days after surgery
Category
Rehabilitation
Recruitment centers
1
Recruitment center
Name of recruitment center
Shariati Hospital, Imam Khomeini cancer institute
Full name of responsible person
Mohammad Masoomzadeh
Street address
No. 68, North Sindokht street, North Kargar street, Tehran
City
Tehran
Province
Tehran
Postal code
1411933886
Phone
+98 31 3668 3368
Email
Mzmasoomzadeh@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Mohammad Masoomzadeh
Street address
No 68, North Sindokht street, North Kargar street, Tehran
City
Tehran
Province
Tehran
Postal code
1411933886
Phone
+98 31 3668 3368
Email
Mzmasoomzadeh@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Tehran university of medical sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Mohammad Masoomzadeh
Position
General Surgery Resident
Latest degree
Medical doctor
Other areas of specialty/work
General Surgery
Street address
No 68, North Sindokht street, North Kargar street, Tehran
City
Tehran
Province
Tehran
Postal code
1411933886
Phone
+98 31 3668 3368
Email
mzmasoomzadeh@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Mohammad Masoomzadeh
Position
General Surgery Resident
Latest degree
Medical doctor
Other areas of specialty/work
General Surgery
Street address
No 68, North Sindokht street, North Kargar street, Tehran
City
Tehran
Province
Tehran
Postal code
1411933886
Phone
+98 31 3668 3368
Email
mzmasoomzadeh@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Mohammad Masoomzadeh
Position
General Surgery Resident
Latest degree
Medical doctor
Other areas of specialty/work
General Surgery
Street address
No 68, North Sindokht street, North Kargar street, Tehran
City
Tehran
Province
Tehran
Postal code
1411933886
Phone
+98 31 3668 3368
Email
mzmasoomzadeh@yahoo.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
All data after concealment of the name can be shared
When the data will become available and for how long
6 Month after publication
To whom data/document is available
Researchers in scientific centers
Under which criteria data/document could be used
Every usage or analysis on the data is permitted with mentioning the source. Requests are sent through email
From where data/document is obtainable
Send request to Dr. Mohammad Masoomzadeh through email address: mzmasoomzadeh@yahoo.com
What processes are involved for a request to access data/document