The aim of study was to compare the effects of gabapentin and gabapentin plus B-Complex -induced analgesia in reducing pain after cesarean section . In this study, pregnant women undergoing cesarean section from 17 to 40 years old who have not underlying medical condition involved. in This double-blind study of 128 patients in two groups: one group of 64 people who gabapentin 300 mg and other group 300mg gabapentin plus B-Complex a half hour before cesarean received .The requirement for analgesia including diclofenac and pethidine is assessed. VPS, sleepy, and vomiting at recovery and 2, 4, 8 and 12 hours after a cesarean section is investigated. All patients received 2.5 mg of bupivacaine 0.5% with a spinal needle placed No. 25 Quinke under spinal anesthesia.. .
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2014040617138N1
Registration date:2014-09-21, 1393/06/30
Registration timing:retrospective
Last update:
Update count:0
Registration date
2014-09-21, 1393/06/30
Registrant information
Name
Ghodrat Allah Soltanian
Name of organization / entity
Ghazvin University of Medical Science
Country
Iran (Islamic Republic of)
Phone
00283359557
Email address
ghsoltanian@qums.ac.ir
Recruitment status
Recruitment complete
Funding source
Gazvin University of Medical Sciences
Expected recruitment start date
2012-11-21, 1391/09/01
Expected recruitment end date
2013-09-16, 1392/06/25
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of gabapentin plus vitamin B - complex and gabapentin alone on pain after spinal
anesthesia for cesarean section
Public title
Effect of Vitamin B-Complexand gabapentin in reducing pain
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: pregnant women undergoing cesarean section between 17 and 40 years old; Patient satisfaction; The absence of an underlying disease, such as heart or lung disease, and seizures; No previous frequent use of analgesics; Lack of drug addiction;
Exclusion criteria: pregnant women undergoing cesarean section are less than 17 years and has more than 40 years; Lack of consent; Underlying disease, such as heart or lung disease, and seizures; Previous repeated use analgesics; Drug Addiction
Age
From 17 years old to 40 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
128
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ghazvin University of Medical Science
Street address
Bahonar Blvd, Qazvin
City
Ghazvin
Postal code
Approval date
2013-11-25, 1392/09/04
Ethics committee reference number
28/20/8102
Health conditions studied
1
Description of health condition studied
Post operative pain
ICD-10 code
O74.9
ICD-10 code description
Complication of anaesthesia during labour and delivery, unspecified
Primary outcomes
1
Description
post operative pain
Timepoint
12 hour after operation
Method of measurement
observation
2
Description
Analgesic demands
Timepoint
First 12 hours
Method of measurement
milligram
Secondary outcomes
1
Description
sleepy
Timepoint
12 hour after operation
Method of measurement
ramsay score scale
2
Description
nausea and vomiting
Timepoint
12 hour after operation
Method of measurement
Require treatment and no treatment is needed.
Intervention groups
1
Description
All the patient in control group receive gabapentin 300 mg and two B-complex tablets orally half an hour before surgery to postoperative analgesia
Category
Treatment - Drugs
2
Description
In case group all the patients receive gabapentin 300 mg orally half an hour before surgery to postoperative analgesia
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Kosar Hospital Ghazvin
Full name of responsible person
Ghodrat Allah Soltanian
Street address
City
Ghazvin
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Ghazvin University of Medical Science
Full name of responsible person
Godrat Allah Soltanian
Street address
Kosar Hospital Ghazvin
City
Ghazvin
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Ghazvin 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
Ghazvin University of Medical Science
Full name of responsible person
Nahid Naseh
Position
Assistant professor
Other areas of specialty/work
Street address
Kosar Hospital Ghazvin
City
Ghazvin
Postal code
Phone
+98 28 3379 0621
Fax
Email
nahid.nasseh@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Ghazvin University of Medical Sciences
Full name of responsible person
Nahid Nahid
Position
Assistant professor
Other areas of specialty/work
Street address
Kosar Hospital Ghazvin
City
Ghazvin
Postal code
Phone
+98 28 3379 0621
Fax
Email
nahid.nasseh@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Ghazvin University of Medical Science
Full name of responsible person
Nahid Naseh
Position
Assistant professor
Other areas of specialty/work
Street address
Kosar Hospital Ghazvin
City
Ghazvin
Postal code
Phone
+98 28 3379 0621
Fax
Email
nahid.nasseh@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)