The purpose of this study will be to assess the effect of pregabalin on postoperative pain in elective craniotomy
Design
Clinical trial with two arm parallel groups, randomised trial with double blinded assessment. Study phase will be 2-3.
Settings and conduct
In Urmia Imam Khomeini hospital operating room the patients with craniotomy surgery with general anesthesia will be devided into two parallel groups (50 patients per group).The drug will be administered by the nurse in the ward and at the time of admission, the anesthesiologist will be unaware which patient will be assigned to which group. Drug containers will be identical and only the nurse will know about the contents of each of them, and finally, after collecting information by the resident in training in anesthesiology, the anesthesiology specialist will be informed of the group each patient is assigned to. After surgery pain will be compared with each other.
Participants/Inclusion and exclusion criteria
Inclusion criteria: being at the age of 20 to 60 years old; American Society of Anesthesiologists class I and II; candidate for elective craniotomy. Exclusion criteria: history of congenital mental retardation or mental disorders; pregnancy or breastfeeding; history of systemic malignant tumor; previous treatment using this protocol or participation in another experimental study within the last 30 days; allergy to the drugs used in the study; body mass index greater than 30; drug or alcohol addiction.
Intervention groups
Intervention group1: patients will receive Pregabalin 300 Mg oral tablet, 90 minutes before surgery.
Intervention group 2: patients will receive placebo oral tablet, 90 minutes before surgery.
Main outcome variables
Pain
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20160430027677N23
Registration date:2022-10-05, 1401/07/13
Registration timing:prospective
Last update:2022-10-05, 1401/07/13
Update count:0
Registration date
2022-10-05, 1401/07/13
Registrant information
Name
Shahryar Sane
Name of organization / entity
Urmia University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 44 3223 4897
Email address
sane.sh@umsu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-10-23, 1401/08/01
Expected recruitment end date
2023-02-20, 1401/12/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of the pregabalin effect on postoperative pain in elective craniotomy
Public title
The effect of pregabalin on postoperative pain in craniotomy
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Being at the age of 20 to 60 years old
American Society of Anesthesiologists class I and II
Being candidate for elective craniotomy
Exclusion criteria:
History of congenital mental retardation or mental disorders
Pregnancy or breastfeeding
History of systemic malignant tumor
Previous treatment using this protocol or participation in another experimental study within the last 30 days
Allergy to the drugs used in the study
Body mass index greater than 30
Drug or alcohol addiction
Age
From 20 years old to 60 years old
Gender
Both
Phase
2-3
Groups that have been masked
Participant
Investigator
Sample size
Target sample size:
50
Randomization (investigator's opinion)
Randomized
Randomization description
Patients will be randomly assigned into two groups pregabaline 300 mg (group P) and placebo (C) using Random Allocation Software 2.0, and the target codes will be written on a piece of paper and placed in sealed envelopes with sequential allocation.
Blinding (investigator's opinion)
Double blinded
Blinding description
The drug will be administered by the nurse in the ward and at the time of admission, the anesthesiologist will be unaware which patient will be assigned to which group. Drug containers will be identical and only the nurse will know about the contents of each of them, and finally, after collecting information by the resident in training in anesthesiology, the anesthesiology specialist will be informed of the group each patient is assigned to.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics commitee of Urmia University of Medical Sciences
Street address
Orjanse alley, Resalat blvd
City
Urmia
Province
West Azarbaijan
Postal code
5714783734
Approval date
2022-08-30, 1401/06/08
Ethics committee reference number
IR.UMSU.HIMAM.REC.1401.037
Health conditions studied
1
Description of health condition studied
Post craniotomy pain
ICD-10 code
R52.0
ICD-10 code description
Acute pain
Primary outcomes
1
Description
pain
Timepoint
In recovery, 6, 12 and 24 hours after surgery
Method of measurement
Visual Analogue Scale
Secondary outcomes
1
Description
Mean Arterial Blood Pressure
Timepoint
In recovery, during Laryngoscopy, 6, 12 and 24 hours after surgery
Method of measurement
None Invasive Blood Pressure
2
Description
Mean pulse Rate
Timepoint
In recovery, during Laryngoscopy, 6, 12 and 24 hours after surgery
Method of measurement
Electrocardiogram
Intervention groups
1
Description
Intervention group: patients will receive Pregabalin 300 Mg oral tablet, 90 minutes before surgery.
Category
Prevention
2
Description
Control group: patients will receive placebo oral tablet, 90 minutes before surgery.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Operating room, Khomeini Hospital
Full name of responsible person
Shahryar Sane
Street address
Ershad blvd, Modarres blvd
City
Urmia
Province
West Azarbaijan
Postal code
5715781351
Phone
+98 44 3346 9931
Fax
+98 44 3346 8967
Email
emam-h-urm@umsu.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Oroumia University of Medical Sciences
Full name of responsible person
Saber Gholizadeh
Street address
Orjanse alley, Resalat blvd
City
Urmia
Province
West Azarbaijan
Postal code
5714783734
Phone
+98 44 3223 4897
Fax
+98 44 3223 4897
Email
research@umsu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Oroumia 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
Oroumia University of Medical Sciences
Full name of responsible person
Shahryar Sane
Position
Associate professor
Latest degree
Subspecialist
Other areas of specialty/work
Anesthesiology
Street address
Orjanse alley, Resalat blvd
City
Urmia
Province
West Azarbaijan
Postal code
5714783734
Phone
+98 44 3223 4897
Fax
+98 44 3346 8967
Email
sanesh@umsu.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Oroumia University of Medical Sciences
Full name of responsible person
Shahryar Sane
Position
Associate professor
Latest degree
Subspecialist
Other areas of specialty/work
Anesthesiology
Street address
Orjanse alley, Resalat blvd
City
Urmia
Province
West Azarbaijan
Postal code
5714783734
Phone
+98 44 3223 4897
Fax
+98 44 3346 8967
Email
sanesh@umsu.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Oroumia University of Medical Sciences
Full name of responsible person
Shahryar Sane
Position
Associate professor
Latest degree
Subspecialist
Other areas of specialty/work
Anesthesiology
Street address
Orjanse alley, Resalat blvd
City
Urmia
Province
West Azarbaijan
Postal code
5714783734
Phone
+98 44 3223 4897
Fax
+98 44 3346 8967
Email
sanesh@umsu.ac.ir
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