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The efficacy of gabapentin after cesarean section in reducing post-cesarean pain in women with elective cesarean section and spinal anesthesia

Protocol summary

Summary
The aim of this study was to evaluate the effectiveness of gabapentin in reducing pain after cesarean section in order to reduce the use of narcotic drugs, which is randomized, double blind, post-marketing, single-center, stage two trials. In this study, participants are randomly categorized in separate groups, thus allowing comparison of interventions to the researcher. Patients under study, women referring to health center, educational, research martyrs Mobini Sabzevar, who intends to have elective cesarean section. The main in inclusion criteria are: Pregnant women with term pregnancy؛ spinal anesthesia؛ aged over eighteen years old؛ with pfannenstiel incision case in previous cesarean section؛ live and single fetus. The main exclusion criteria included: need general anesthesia؛ analgesic use 8 hours before surgery؛ use non-steroidal anti-inflammatory drugs 24 hours before surgery, and the patients are divided into two groups of 51, comprising the control group (1 placebo capsule) and the intervention group (1 capsule gabapentin 300 mg). Both groups receive oral medication, then cesarean section. The main study is pain.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2017081635740N1
Registration date: 2017-09-17, 1396/06/26
Registration timing: registered_while_recruiting

Last update:
Update count: 0
Registration date
2017-09-17, 1396/06/26
Registrant information
Name
sara hajiseyedi
Name of organization / entity
Sabzevar University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 44011000051
Email address
hajiseyedis88@medsab.ac.ir
Recruitment status
Recruitment complete
Funding source
Sabzevar University of Medical Sciences
Expected recruitment start date
2017-08-22, 1396/05/31
Expected recruitment end date
2017-10-23, 1396/08/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The efficacy of gabapentin after cesarean section in reducing post-cesarean pain in women with elective cesarean section and spinal anesthesia
Public title
Effect of gabapentin in post-cesarean pain
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Patients who were willing to participate in the study and signed an informed consent letter; age 18 and above; Pregnancy age between 37 and 42 weeks؛ Term pregnancy; Having a live and monolingual fetus; Auxillary tempreture less than 37.5 degrees; Pfannenstiel incision in the previous cesarean section; Elective cesarean; Spinal anesthesia; No history of seizure; No history of gabapentin susceptibility; No history of psychiatric disorders; No Infectious Disease AIDS and hepatitis; Absence of uncontrolled blood pressure and diabetes; No systemic disease to moderate to severe; No alcohol and drug addiction. Exclusion criteria: Patient's lack of cooperation; Analgesic use 8 hours before surgery; Use of non-steroidal anti-inflammatory drugs 24 hours before surgery; Need for general anesthetic.
Age
From 77 years old
Gender
Female
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size: 102
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double 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 Sabzevar University of Medical Sciences and Health Services
Street address
Central Organization of Medical Sciences, Asad Abadi Street, sabzevar
City
Sabzevar
Postal code
Approval date
2017-06-12, 1396/03/22
Ethics committee reference number
IR.MEDSAB.REC.1396.12

Health conditions studied

1

Description of health condition studied
Pain after cesarean section
ICD-10 code
ICD-10 code description

Primary outcomes

1

Description
Pain after cesarean section
Timepoint
6 times in recovery and at hours 2, 4, 6, 12, 24 after cesarean section
Method of measurement
Visual Scale of Pain

Secondary outcomes

empty

Intervention groups

1

Description
In the intervention group: gabapentin, 300 mg capsule, oral, single dose, Mehr Pharmaceutical Company
Category
Treatment - Drugs

2

Description
In the control group: placebo, oral, single dose, capsule
Category
Placebo

Recruitment centers

1

Recruitment center
Name of recruitment center
Shahidan Mobini Hospital
Full name of responsible person
Street address
North Kashefi Avenue, Sabzevar
City
Sabzevar

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice Chancellor for research of sabzevar University of Medical Science
Full name of responsible person
Ms. Elham Bashtani
Street address
Vice Chancellor for research, near to trooper, sabzevar
City
Sabzevar
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice Chancellor for research of sabzevar University of Medical Science
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty

Person responsible for general inquiries

Contact
Name of organization / entity
Sabzevar University of Medical Sciences
Full name of responsible person
M.s Sara Hajiseyedi
Position
Medical student
Other areas of specialty/work
Street address
Central Organization of Medical Sciences, Asad Abadi Street, sabzevar
City
Sabzevar
Postal code
Phone
+98 51 4401 1000
Fax
Email
info@medsab.ac.ir
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Sabzevar University of Medical Sciences
Full name of responsible person
Mrs. Behnaz Sovizi
Position
Obstetricians
Other areas of specialty/work
Street address
Central Organization of Medical Sciences, Asad Abadi Street, Sabzevar
City
Sabzevar
Postal code
Phone
+98 51 4401 1000
Fax
Email
info@medsab.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Sabzevar University of Medical Sciences
Full name of responsible person
Sara Hajiseyedi
Position
medical student
Other areas of specialty/work
Street address
Central Organization of the University of Medical Sciences,Asad Abadi Street, sabzevar
City
Sabzevar
Postal code
Phone
+98 51 4426 4462
Fax
Email
hajiseyedisara@gmail.com
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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