Objective: To compare the effect of the spinal pethidine with epidural bupivacaine in relief of labor pain.
Population: patients were randomly divided into two groups. The first group of were consists of 25 patients who received spinal anesthesia and the second group were 25 patients that received an epidural one.
Sample size: 25 pregnant women who were candidates for vaginal delivery with epidural bupivacaine and 25 cases with spinal anesthesia with pethidine.
Methods and materials: at first about 500-1000cc serum(ringer ) were infused for all the patients of pethidine group In the first group for prevention of nausea and vomiting metoclopramide ( mg100) dexamethasone(8mg) was injected intravenously. The patient was placed in a sitting position and a 25-gauge needle with the tip bent( Aspanyal)were used , 25 mg pethidine +1/5 mgdextrose 10% of the total volume 2cc (hyper time being) was injected into the subarachnoid space.
In the second group (epidural anesthesia) epidural catheter 20 in the L3 - L4 space were used when the cervix is 4cm.The bolus dose 0/125 percent (15cc) of bupivacaine and fentanyl3/12 microgram/cc in three divided dose every 5 minutes were used. The dose was repeated if the effect of drug were disappeared before delivery.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2013060312701N5
Registration date:2013-06-13, 1392/03/23
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2013-06-13, 1392/03/23
Registrant information
Name
Mohammad Forozeshfard
Name of organization / entity
Semnan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 23 2362 2990
Email address
mff@sem-ums.ac.ir
Recruitment status
Recruitment complete
Funding source
Semnan University of Medical Sciences
Expected recruitment start date
2013-01-03, 1391/10/14
Expected recruitment end date
2013-07-05, 1392/04/14
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
comparison Spinal and epidural anesthesia with bupivacaine and pethidine in Painless Childbirth
Public title
Spinal and epidural anesthesia with bupivacaine and pethidine in Painless Childbirth
Purpose
Supportive
Inclusion/Exclusion criteria
The study group were all pregnant women who were candidate for the normal vaginal delivery and they had no underlying disease consists of heart disease and asthma.
Age
No age limit
Gender
Female
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
50
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Semnan University of Medical Services
Street address
Semnan University of Medical Services
City
semnan
Postal code
Approval date
2012-08-07, 1391/05/17
Ethics committee reference number
5845/16/91
Health conditions studied
1
Description of health condition studied
Single spontaneous delivery
ICD-10 code
O80
ICD-10 code description
Single spontaneous delivery
Primary outcomes
1
Description
Analgesia
Timepoint
Before and after the intervention to end delivery process
Method of measurement
Numeric Rating Pain Scale
Secondary outcomes
1
Description
Changes in blood pressure
Timepoint
From start to finish the process of intervention delivery
Method of measurement
Pressure gauge
2
Description
Nausea and vomiting
Timepoint
From start to finish the process of intervention delivery
Method of measurement
Nausea, and stomach contents during delivery
3
Description
Respiratory depression
Timepoint
From start to finish the process of intervention delivery
Method of measurement
Observational
Intervention groups
1
Description
The first group of 25 patients who received spinal anesthesia.
Category
Treatment - Drugs
2
Description
The second group of 25 patients who received an epidural.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Amiralmomenin hospital
Full name of responsible person
Forozeshfard Mohammad
Street address
Semnan University of Medical Sciences
City
Semnan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Semnan University of Medical Sciences
Full name of responsible person
Raheb Ghorbany
Street address
Semnan University of Medical Sciences
City
semnan
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Semnan 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
Semnan University of Medical Sciences
Full name of responsible person
Forozeshfard Mohammad
Position
Professional MD
Other areas of specialty/work
Street address
Semnan University of Medical Sciences
City
Semnan
Postal code
Phone
+98 23 1446 0099
Fax
Email
mff@sem-ums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Semnan University of Medical Sciences
Full name of responsible person
Forozeshfard Mohammad
Position
Professional MD
Other areas of specialty/work
Street address
Semnan University of Medical Sciences
City
Semnan
Postal code
Phone
+98 23 1446 0099
Fax
Email
mff@sem-ums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Semnan University of Medical Services
Full name of responsible person
Forozeshfard Mohammad
Position
Professional MD
Other areas of specialty/work
Street address
Semnan University of Medical Services
City
Semnan
Postal code
Phone
+98 23 1446 0099
Fax
Email
mff@sem-ums.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)