Effect of co-administration of oral pregabalin and intravenous ketorolac on post-operative pain in patients undergoing cesarean section with spinal anesthesia.
Evaluation of the effect of concomitant oral administration of pregabalin and intravenous ketorolac on postoperative pain in patients undergoing spinal sensory cesarean section
Design
A clinical trial with a control group, with parallel groups, without blinding, with random allocation using the table of random numbers, phase 3 on 56 patients.
Settings and conduct
One hour before the operation, patients in the intervention group received one 150 mg oral pregabalin capsule and a dose of 30 mg intravenous ketorolac and in the control group, patients received placebo.
After 15 minutes, the patient is placed in a sitting position and received 2.5 cc of bupivacaine hyperbaric via spinal cord with needle No. 25 after the CSF is expelled. Intravenous ringer lactate 15 cc/kg/h is prescribed until the end of surgery. After the fetus delivered, 10 units of oxytocin are slowly infused into one liter of serum. Postoperatively, patients' pain will be assessed at three-times (6, 12, and 24 hours) using a VAS scale.
Study place: Imam Reza hospital and Ghaem hospital in Mashhad.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Pregnant mothers with I ASA and 18-40 years old candidates for elective cesarean section and spinal anesthesia and have no history of any neurological disease, calcium channel blocker, and analgesia in the last 3 months.
Exclusion criteria: the need for general anesthesia for any reason, contraindications to spinal surgery, and people who have a contraindication for pregabalin use.
Intervention groups
Intervention group: This group receives a 150 mg capsule of pregabalin and a dose of 30 mg ketorolac intravenously one hour before surgery.
Control group: This group receives one placebo capsule with a 30 mg intravenous dosage block 1 hour before surgery.
Main outcome variables
Pain (VAS)
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20220114053711N1
Registration date:2022-08-26, 1401/06/04
Registration timing:prospective
Last update:2022-08-26, 1401/06/04
Update count:0
Registration date
2022-08-26, 1401/06/04
Registrant information
Name
seyed majid taghizadeh mayani
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 51 3800 2000
Email address
taghizadehm3@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-12-06, 1401/09/15
Expected recruitment end date
2023-03-06, 1401/12/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of co-administration of oral pregabalin and intravenous ketorolac on post-operative pain in patients undergoing cesarean section with spinal anesthesia.
Public title
Effect of co-administration of oral pregabalin and intravenous ketorolac on post-operative pain in patients undergoing cesarean section with spinal anesthesia.
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Pregnant mothers with I ASA and 18-40 years old who are candidates for elective cesarean section and spinal anesthesia, sign the informed consent form to participate in this project.
Do not have a history of any neurological disease in the last three months.
There are no contraindications to spinal surgery (hemodynamic abnormalities, coagulation defects, history of allergy to local anesthetics, lack of patient cooperation, and local infection).
Do not have a history of taking calcium channel blockers and painkillers in the last three months.
Exclusion criteria:
Need general anesthesia for any reason
People with a contraindication for pregabalin use (a history of previous allergies to pregabalin or any of the ingredients in its formulation). Community Verified icon
Age
From 18 years old to 40 years old
Gender
Female
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
56
Randomization (investigator's opinion)
Randomized
Randomization description
Sampling method is available and patients are divided into two groups of intervention (n = 28) and placebo (n = 28) based on random allocation method (with table of random numbers). The assigned codes are written separately on separate sheets and placed in separate envelopes or updated in such a way that the code written inside them is not available. After each patient with inclusion criteria is referred, an envelope is removed in order and according to the code written in it (for example a / b) the patient is placed in one of two groups.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Mashhad University of Medical Sciences
Street address
Danesh and Salamat Shahrek, between Shahidjovan and Al Shahidi Square, Shaheed Fakuri Blvd, Mashhad, Khorasan Razavi
City
Mashhad
Province
Razavi Khorasan
Postal code
9138813944
Approval date
2022-06-13, 1401/03/23
Ethics committee reference number
IR.MUMS.MEDICAL.REC.1401.172
Health conditions studied
1
Description of health condition studied
cesarean section
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Postoperative pain
Timepoint
at 6, 12, and 24 hours after surgery
Method of measurement
VAS (visual analog scale)
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: This group receives a 150 mg capsule of pregabalin one hour before the operation and a 30 mg dose of intravenous ketorolac during the operation after clamping the Tuff band.
Category
Treatment - Drugs
2
Description
Control group: The control group receives a placebo one hour before the operation.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Emam Reza hospital of Mashhad
Full name of responsible person
ُُSeyyed Majid Taghizadeh Mayani
Street address
Imam Reza Research and Treatment Center, Imam Reza Hospital Square, Ibn Sina St, Mashhad, Khorasan Razavi
City
Mashhad
Province
Razavi Khorasan
Postal code
+989137913316
Phone
+98 51 3854 3031
Email
presidentoffice@mums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Dr. Majid Ghayor Mobarhan
Street address
Mashhad, University Street, University of Medical Sciences, University Research and Technology Vice-Chancellor, 3rd floor
City
Mashhad
Province
Razavi Khorasan
Postal code
9138813944
Phone
+98 51 3841 1538
Email
vcresraech@mums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Mashhad 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
Mashhad University of Medical Sciences
Full name of responsible person
Seyed Majid Taghizadeh Mayani
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Anesthesiology
Street address
Mashhad Central Medical Sciences Building, University Street.
City
Mashhad
Province
Razavi Khorasan
Postal code
9138813944
Phone
+98 51 3800 2000
Fax
Email
taghizadehm3@mums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Seyed Majid Taghizadeh Mayani
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Anesthesiology
Street address
Mashhad Central Medical Sciences Building, University Street.
City
Mashhad
Province
Razavi Khorasan
Postal code
9138813944
Phone
+98 51 3800 2000
Fax
Email
taghizadehm3@mums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Seyed Majid Taghizadeh Mayani
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Anesthesiology
Street address
Mashhad Central Medical Sciences Building, University Street.
City
Mashhad
Province
Razavi Khorasan
Postal code
9138813944
Phone
+98 51 3800 2000
Fax
Email
taghizadehm3@mums.ac.ir
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 is potentially shareable after de-identifying individuals.
When the data will become available and for how long
The access period starts 6 months after the results are published.
To whom data/document is available
The data will be available only to researchers working in academic and scientific institutions.
Under which criteria data/document could be used
The data can only be requested by academic and scientific researchers and after providing documentation indicating their employment and providing documentation indicating the reason for requesting the data.
From where data/document is obtainable
Central Organization of Mashhad University of Medical Sciences,
number: 051 38049
What processes are involved for a request to access data/document
After the request from Mashhad University of Medical Sciences, the review will be done in about three months.