Evaluation of the effect of duloxetine before and after surgery in reducing the vas score of patients after surgery compared to the control group in Shah Vali Hospital in Yazd in patients undergoing spinal stenosis surgery
Design
Clinical trial with intervention and control groups with parallel groups of double-blind randomized phase 2 on 64 patients.
Settings and conduct
shahvali hospital
Participants/Inclusion and exclusion criteria
Inclusion criteria for all patients with spinal canal stenosis and exclusion criteria for drug allergy and abnormal liver and kidney function test and use of opioids, gaba pentin and pregabalin for more than three months and pregnant women and patients with Psychiatry disorders and seizure disorders
Intervention groups
samples are divided into two groups. The intervention group will receive 60 mg of oral duloxetine daily for 1 day before surgery, 60 mg daily from the day of surgery to the first day after surgery (total for 3 days). The control group will receive a placebo with the same schedule and time.
Main outcome variables
Time required for analgesia, pain intensity, type of medication used
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20210124050130N1
Registration date:2021-08-07, 1400/05/16
Registration timing:registered_while_recruiting
Last update:2021-08-07, 1400/05/16
Update count:0
Registration date
2021-08-07, 1400/05/16
Registrant information
Name
Mitra Shahriarypoor
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 35 3822 5260
Email address
mitrashahriary143@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-06-26, 1400/04/05
Expected recruitment end date
2021-09-22, 1400/06/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of the Perioperative and Postoperative effects of Duloxetine in reducing postoperative pain in patients with spinal stenosis
Public title
evaluation of the effect of duloxetine in reducing pain
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
all patients with spinal stenosis
Exclusion criteria:
Allergy to the test drug
Abnormal liver and kidney function test
Use of opioids, gabapentin and pregabalin for more than three months
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Care provider
Investigator
Outcome assessor
Data and Safety Monitoring Board
Sample size
Target sample size:
64
Randomization (investigator's opinion)
Randomized
Randomization description
Patients are randomly divided into two groups by simple randomization method. How to select people and place them in dual groups will be random. Thus, after confirming the necessary conditions to enter the study, patients will be selected sequentially, the first patient in the first group, the second patient in the second group. In the same way, again, the groups will take each patient until the desired limit is reached, the number of samples in the intervention and control groups is equal.
Blinding (investigator's opinion)
Double blinded
Blinding description
The studied drugs were prepared by a neurosurgeon who did not participate in the project later and were stored in sealed envelopes on which the patient code was written. The envelopes were in the neurosurgery ward one day before surgery; Day of surgery; day after surgery; It is opened by a neurosurgeon who does not know the type of drug and the group in which the patient is placed. Nurses and patients are also unaware of the type of drug and the patient group.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
ethics committee of azad yazd university of medical sciences
Street address
shohadaye gomnam blvd
City
yazd
Province
Yazd
Postal code
8915813135
Approval date
2021-05-16, 1400/02/26
Ethics committee reference number
IR.IAU.YAZD.REC.1400.004
Health conditions studied
1
Description of health condition studied
Evaluation of the Perioperative and Postoperative effects of Duloxetine in reducing postoperative pain in patients with spinal stenosis
ICD-10 code
M48.0
ICD-10 code description
Spinal stenosis
Primary outcomes
1
Description
numeric rating scale according to visual analogue scale
Timepoint
visual analogue scale before surgery and 2 hours after surgery and 24 hours after surgery
Method of measurement
by visual analogue scale criterion
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: will receive 60 mg of oral duloxetine daily for 1 day before surgery, 60 mg daily from the day of surgery to the first day after surgery (total 3 days).
Category
Treatment - Drugs
2
Description
Control group: placebo one day before surgery;day of surgery;one day after surgery
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Shahvali Hospital
Full name of responsible person
Hamid Hobobati
Street address
Shohadaye Gomnam Blvd
City
Yazd
Province
Yazd
Postal code
89195155
Phone
+98 35 3821 1091
Email
Shahvali.Hospital93@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Islamic Azad University
Full name of responsible person
Ahmad Shajari
Street address
Shohadaye gomnam blvd
City
Yazd
Province
Yazd
Postal code
8915813135
Phone
+98 35 3821 0540
Email
ethics.iauyazdmedical@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Islamic Azad University
Proportion provided by this source
100
Public or private sector
Private
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
Islamic Azad University
Full name of responsible person
Mitra Shahriary poor
Position
Medical intern
Latest degree
A Level or less
Other areas of specialty/work
Others
Street address
Shahid ghandi Blvd
City
Yazd
Province
Yazd
Postal code
8915877851
Phone
+98 34 4225 7756
Email
mitrashahriary143@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Hamid Hobobati
Position
Neurosurgeon
Latest degree
Specialist
Other areas of specialty/work
Neurosurgery
Street address
Shahid ghandi blvd
City
Yazd
Province
Yazd
Postal code
8915877851
Phone
+98 35 3728 8008
Email
hh1358@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Mitra Shahriary poor
Position
Medical intern
Latest degree
A Level or less
Other areas of specialty/work
Others
Street address
Shahid ghandi Blvd
City
Yazd
Province
Yazd
Postal code
8915877851
Phone
+98 34 4225 7756
Email
mitrashahriary143@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available