Investigating the effect of Gabapentin in mothers undergoing spinal anesthesia for Caesarean section.
Design
A controlled, parallel-group, Double-blind, block randomized, phase 2 clinical trial on 25 patients in each group.
Settings and conduct
Primipara mothers (18-40 years old) undergoing caesarian section at Gynecology & Obstetrics OR, Ghaem Hosp. under spinal anesthesia will receive 300 mg Gabapentin (or identical placebo) 1 h before surgery. The pain intensity will be evaluated at 6, 12, and 24 h using VAS after surgery.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Primipara class 1 (ASA) mothers at 18-40 years old undergoing caesarean section with spinal anesthesia and no history of neurological disease, calcium channel blockers consumption in the last month; no contraindication for spinal surgery; no coagulopathies; no history of sensitivity to local anesthetics; no local infection
Exclusion criteria: Patients in need for general anesthesia for any reason will be excluded from the study.
Intervention groups
300 mg of Gabapentin one hour before surgery and another group receives a placebo.
Main outcome variables
Postoperative pain
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20230311057674N1
Registration date:2024-05-26, 1403/03/06
Registration timing:prospective
Last update:2024-05-26, 1403/03/06
Update count:0
Registration date
2024-05-26, 1403/03/06
Registrant information
Name
Mahdeih Jafari
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 51 3882 8888
Email address
jafarimh@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-06-21, 1403/04/01
Expected recruitment end date
2024-07-22, 1403/05/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of the effect of Gabapentin on post-operative pain in patients undergoing Caesarean section under spinal anesthesia
Public title
Evaluation of the effect of Gabapentin on post-operative pain in patients undergoing Caesarean section under spinal anesthesia
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Pregnant mother first pregnancy with I ASA and age 18-40 who is a candidate for elective caesarean section and Spanish anesthesia.
Exclusion criteria:
There is no history of any neurological disease and calcium channel blocker in recent month and contraindication of Gabapentin and without spinal contraindication criteria, coagulation defects, history of sensitivity to local anesthetics, noncooperation and local infection.
Age
From 18 years old to 40 years old
Gender
Female
Phase
2-3
Groups that have been masked
Participant
Care provider
Outcome assessor
Sample size
Target sample size:
25
Randomization (investigator's opinion)
Randomized
Randomization description
In this study, we are going to use simple randomization bloked. In this study, 50 eligible patients with two arms will be selected by blocking method. Ten random samples with different sizes of 4 and 6 and different sequences from the https://www.sealedenvelope.com/simple-randomiser/v1/lists site will be selected as described below, and the contents of each block will be kept in sealed and opaque envelopes with someone who is blinded to the grouping and when referring to the order of the blocks will be opened and depending on the sequence of the contents of that person in one of the arms of the study. Accordingly, completion of the first block and the second block is randomly selected and this continues until the last block and the last person is assigned to the arms of the study. Normally, by allocating the last leaf of the last block of the patient blocks, it is grouped in two arms of study and balance is established between the two groups.
Blinding (investigator's opinion)
Double blinded
Blinding description
the contents of each block will be kept in sealed and opaque envelopes with someone who is blinded to the grouping.
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
Daneshgah st, Mashhad
City
Mashhad
Province
Razavi Khorasan
Postal code
9138813944
Approval date
2023-02-27, 1401/12/08
Ethics committee reference number
IR.MUMS.IRH.REC.1401.076
Health conditions studied
1
Description of health condition studied
Caesarean section
ICD-10 code
O82
ICD-10 code description
Encounter for Caesarean section without indication
Primary outcomes
1
Description
Severity of pain after caesarean section in patients
Timepoint
6, 12, and 24 hours after the operation
Method of measurement
It will be evaluated using the Visual Analogue Scale (VAS) questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Gabapentin 600 mg orally and the second group received placebo one hour before the operation.
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
Qaem Educational, Research and Treatment Center Mashhad University of Medical Sciences
Full name of responsible person
Mahdieh Jafari
Street address
Between shahid javan and Ale shahidi Sq, Shahid Fakoori Blvd, Mashhad, Iran
City
Mashhad
Province
Razavi Khorasan
Postal code
٩٩١٩١ ٩١٧٧٨
Phone
+98 51 3879 5031
Email
jafarimh@mums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Mohsen Tafaghodi
Street address
Daneshgah st, Mashhad
City
Mashhad
Province
Razavi Khorasan
Postal code
9138813944
Phone
+98 51 3841 1538
Fax
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
Mahdieh Jafari
Position
Assistant Professor of Anesthesiology
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Between shahid javan and Ale shahidi Sq, Shahid Fakoori Blvd, Mashhad, Iran
City
Mashhad
Province
Razavi Khorasan
Postal code
9178799191
Phone
+98 51 3879 5031
Fax
Email
jafarimh@mums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Mahdieh Jafari
Position
Assistant Professor of Anesthesiology
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Between shahid javan and Ale shahidi Sq, Shahid Fakoori Blvd, Mashhad, Iran
City
Mashhad
Province
Razavi Khorasan
Postal code
9178799191
Phone
+98 51 3879 5031
Email
jafarimh@mums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Mahdieh Jafari
Position
Assistant Professor of Anesthesiology
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Between shahid javan and Ale shahidi Sq, Shahid Fakoori Blvd, Mashhad, Iran
City
Mashhad
Province
Razavi Khorasan
Postal code
9178799191
Phone
+98 51 3879 5031
Email
jafarimh@mums.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