In double blind randomized clinical trail, 60 patients candidate for elective caesarian with ASA I –II who accepted to come to study divide to equals group(n=30). All the patients in control group receive 15 micrograms of fentany plus bupiuvacaine .05% up to 2 milliliter. Fentany is a synthetic opioid with receptor in CNS. In case group all the patients receive 300 milligrams gabapentin 2 hours before surgery and receive bupiuvacaine .05% up to 2 milliliter intratechaly before surgery. Gabapentin is gaba amino butyric acid inhibitor and can reduce post operative pain. Pain score, need to analgesic drugs, patient satisfaction, neonate apgar and time of discharge, will be recorded and analyzed in study groups.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201202241936N8
Registration date:2012-03-01, 1390/12/11
Registration timing:prospective
Last update:
Update count:0
Registration date
2012-03-01, 1390/12/11
Registrant information
Name
Abdolreza Najafi Anaraki
Name of organization / entity
Bushehr University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 77 1354 0088
Email address
najafianaraki@bpums.ac.ir
Recruitment status
Recruitment complete
Funding source
Bushehr University of Medical Science
Expected recruitment start date
2012-03-19, 1390/12/29
Expected recruitment end date
2012-08-21, 1391/05/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of Preemptive Effect of Gabapentine and Intra techal Fentanyl on Post operative Pain after Caesarean Surgery.
Public title
Comparison of Preemptive Effect of Gabapentine and Intra techal Fentanyl on Post operative Pain after Caesarean Surgery.
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: the entire patient candidates for elective cesarean age between 20 till 40 that accept to come to study are inclusion criteria.
Exclusion criteria: history of sensitivity to gabapentin; patient with hepatic and renal problem; history of epilepsy; patients that received analgesic 8 hours before surgery; patients with psychological problem; history of sensitivity to opioids and any situation that made regional anesthesia contraindicated.
Age
From 20 years old to 40 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
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
Bushehr university of medical science
Street address
Bushehr-SIRAF AVENUE
City
Bushehr
Postal code
Approval date
2012-02-08, 1390/11/19
Ethics committee reference number
B-90-13-9
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
First 24 hours
Method of measurement
Observation
2
Description
Analgesic demands
Timepoint
First 24 hours
Method of measurement
Observation
Secondary outcomes
1
Description
Patients' statisfication
Timepoint
First 24 hours
Method of measurement
Question
Intervention groups
1
Description
In case group all the patients receive spinal anesthesia with bupiuvacaine .05% up to 2 milliliter.in this group all the patients receive 300 milligrams gabapentin orally 2 hours before surgery as preemptive analgesic protocol.
Category
Treatment - Drugs
2
Description
All the patient in control group receive 15 micrograms of fentany as pain protocol plus bupiuvacaine .05% up to 2 milliliter intratechaly
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Bentolhoda hospital
Full name of responsible person
Street address
City
Bushehr
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Bushehr University of Medical Sciences
Full name of responsible person
Dr majid asady
Street address
Bushehr University of Medical Sciences
City
Bushehr
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Bushehr University of Medical Sciences
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
Bushehr University of Medical Science
Full name of responsible person
Dr. Abdolreza Najafi Anaraki
Position
Assistant professor
Other areas of specialty/work
Street address
Bushehr University of Medical Science
City
Bushehr
Postal code
Phone
+98 77 1252 2417
Fax
Email
DR.NAJAFIANARAKI@GMAIL.COM
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Bushehr University of Medical Science
Full name of responsible person
Dr. Abdolreza Najafi Anaraki
Position
Assistant professor
Other areas of specialty/work
Street address
Bushehr University of Medical Science
City
Bushehr
Postal code
Phone
+98 77 1252 2417
Fax
Email
DR.NAJAFIANARAKI@GMAIL.COM
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Bushehr University of Medical Science
Full name of responsible person
Dr Abdolreza Najafi Anaraki
Position
Assistant Professor
Other areas of specialty/work
Street address
Bushehr
City
Bushehr
Postal code
Phone
+98 77 1252 2417
Fax
Email
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)