The aim of this study was to evaluate the effect of meperidine 5 mg as an additive to bupivacaine for spinal anesthesia on postoperative pain in cesarean section surgery. This double blind randomized clinical trial study was performed on 40 patients aged 20-50 yr with American society anesthesia physical classification system (ASA) 1 or 2 were scheduled for elective cesarean surgery under spinal anesthesia. Patients were randomized according to usage of meperidine or normal salin as an additive to bupivacaine for spinal anesthesia. All patients with pre-existing or pregnancy-induced hypertension, known fetal abnormality or allergy to bupivacaine or meperidine were excluded. Postoperative analgesia was compared between two groups immediately and 2, 12, 24 hours after surgery. Also, the need for antiemetic was compared between groups.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2015052821383N2
Registration date:2016-03-20, 1395/01/01
Registration timing:retrospective
Last update:
Update count:0
Registration date
2016-03-20, 1395/01/01
Registrant information
Name
Amir Saber Tanha
Name of organization / entity
Birjand University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 56 3243 2778
Email address
dr.saber@bums.ac.ir
Recruitment status
Recruitment complete
Funding source
Birjand University of Medical Sciences.
Expected recruitment start date
2015-02-05, 1393/11/16
Expected recruitment end date
2015-08-07, 1394/05/16
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of the effect of addition of 5 mg meperidine to 10 mg bupivacaine for spinal anesthesia on postoperative pain in cesarean section surgery.
Public title
The effect of addition of meperidine to intrathecal bupivacaine on postoperative pain after cesarean section.
Purpose
Prevention
Inclusion/Exclusion criteria
inclusion criteria: all patients 20-50 years with score 1-2 according to American Society of Anesthesia classification for risk of anesthesia were scheduled for cesarean section under spinal anesthesia.
Exclusion criteria: pre-existing or pregnancy-induced hypertension, known fetal abnormality or allergy to bupivacain or mepridine.
Age
From 20 years old to 50 years old
Gender
Female
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
40
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
Birjand University of Medical Sciences
Street address
Birjand University of Medical Sciences, Ghafari Street, Birjand
City
Birjand
Postal code
Approval date
2015-01-26, 1393/11/06
Ethics committee reference number
1393-11-01
Health conditions studied
1
Description of health condition studied
Cesarean section
ICD-10 code
O30-048
ICD-10 code description
Maternal care related to the fetus and amniotic cavity and possible delivery problems
Primary outcomes
1
Description
Postoperative pain
Timepoint
Immediately after surgery, 2, 12, 24 hours after surgery
Method of measurement
Visual analog score of pain
Secondary outcomes
1
Description
Intraoperative nausea and vomiting
Timepoint
Intraoperative
Method of measurement
Incidence of vomiting or need for administration of antiemetic drug.
Intervention groups
1
Description
Intrathecal injection of 0.5% hyperbaric bupivacaine 2.0 ml plus normal saline 0.5 ml
Category
Prevention
2
Description
Intrathecal injection of 0.5% hyperbaric bupivacaine 2.0 ml plus 1% meperidine 0.5 ml
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
Valiasr hospital of Birjand University of Medical Sciences
Full name of responsible person
Dr. Amir Saber Tanha
Street address
Valiasr hospital, Ghafari Street, Birjand
City
Birjand
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Birjand University of Medical Sciences
Full name of responsible person
Dr. Asghar Zarban
Street address
Birjand University of Medical Sciences, Ghafari Street, Birjand
City
Birjand
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Birjand 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
Birjand University of Medical Sciences
Full name of responsible person
Dr. Amir Saber Tanha
Position
Assistant professopr of anesthesia
Other areas of specialty/work
Street address
Birjand University of Medical Sciences, Ghafari Street, Birjand
City
Birjand
Postal code
Phone
+98 56 3244 3001
Fax
Email
amirsaber63@gmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Birjand university of Medical Sciences
Full name of responsible person
Dr. Amir Saber Tanha
Position
Anesthesiologist, Assistant professor
Other areas of specialty/work
Street address
Birjand University of Medical Sciences, Ghafari Street, Birjand, Iran
City
Birjand
Postal code
Phone
+98 56 3244 3001
Fax
Email
amirsaber63@gmail.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Birjand University of Medical Sciences
Full name of responsible person
ِDr. Amir Saber Tanha
Position
Assisstant professore of anesthesia
Other areas of specialty/work
Street address
Birjand University of Medical Sciences, Ghafari Street, Birjand, Iran
City
Birjand
Postal code
Phone
Fax
Email
amirsaber63@gmail.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)