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Comparison the Analgesic Effects of Acetaminophen, Meperidine, and their Combination on Postoperative Pain Management in Elective Cesarean Section Surgeries under Spinal Anesthesia

Protocol summary

Study aim
Comparison the analgesic Effects of Acetaminophen, Meperidine, and Their Combination on Postoperative Pain Management in Elective Cesarean Section Surgeries under spinal anesthesia
Design
randomized double-blind, parallel-group
Settings and conduct
The patients were randomly allocated to three groups as follows: Group one:40 patients received 15mg/kg iv. acetaminophen (diluted in 100 cc normal saline solution), Group two:40 patients received 0.5mg/kg iv meperidine Group three:40 patients received 15mg/kg iv. acetaminophen + 0.5mg/kg meperidine within 15 minutes in the Hafez Hospital, Shiraz,
Participants/Inclusion and exclusion criteria
Inclusion criteria:120 full-term pregnant women aged 18 to 40 years old with ASA I, undergoing elective cesarean section under spinal anesthesia. Exclusion criteria: contraindications for meperidine or acetaminophen, history of alcoholism, drug abuse, convulsion, migraine, dicopathy, hepatitis, renal failure, cardiovascular or pulmonary diseases, preeclampsia or eclampsia, hypertension, and diabetes, below high school education, gravidity more than 3, surgery more than 90-minute, failed or partial Sspinal anesthesia, fetal distress, Intrauterine Growth Restriction (IUGR), multiple pregnancies.
Intervention groups
Group one:40 patients received 15mg/kg iv. acetaminophen (diluted in 100 cc normal saline solution), Group two:40 patients received 0.5mg/kg iv meperidine Group three:40 patients received 15mg/kg iv. acetaminophen + 0.5mg/kg
Main outcome variables
pain score, nausea, vomiting, shivering, headache.

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20141009019470N75
Registration date: 2018-05-04, 1397/02/14
Registration timing: retrospective

Last update: 2018-05-04, 1397/02/14
Update count: 0
Registration date
2018-05-04, 1397/02/14
Registrant information
Name
Farzaneh Masihi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 71 3647 4270
Email address
masihif@sums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-01-05, 1396/10/15
Expected recruitment end date
2018-03-06, 1396/12/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison the Analgesic Effects of Acetaminophen, Meperidine, and their Combination on Postoperative Pain Management in Elective Cesarean Section Surgeries under Spinal Anesthesia
Public title
Comparison the Analgesic Effects of Acetaminophen, Meperidine, and their Combination in Elective Cesarean Section Surgeries under Spinal Anesthesia
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
full-term pregnant women aged 18 to 40 years old American Society of anesthesiologists physical status classification I(ASA I) undergoing elective cesarean section under spinal anesthesia
Exclusion criteria:
contraindications for meperidine or acetaminophen history of alcoholism drug abuse convulsion migraine dicopathy hepatitis renal failure cardiovascular or pulmonary diseases preeclampsia or eclampsia, hypertension diabetes, gravidity more than 3 surgery more than 90-minute failed or partial S/A, Intrauterine Growth Restriction (IUGR), multiple pregnancies fetal distress
Age
From 18 years old to 40 years old
Gender
Female
Phase
2-3
Groups that have been masked
  • Participant
  • Investigator
Sample size
Target sample size: 120
Randomization (investigator's opinion)
Randomized
Randomization description
Patients were randomized according to the charts which was derived from www.randomization.com site.
Blinding (investigator's opinion)
Double blinded
Blinding description
pregnant woman undergoing cesarean section and investigators were blinded to the study treatments.
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Shiraz University of Medical Sciences
Street address
Vice Chancellor of research, Shiraz University of Medical Sciences, 7th floor, central building of Shiraz University of Medical Sciences, Zand street
City
Shiraz
Province
Fars
Postal code
7134844119
Approval date
2017-12-22, 1396/10/01
Ethics committee reference number
IR.SUMS.MED.REC.1396.110

Health conditions studied

1

Description of health condition studied
Elective Cesarean Section
ICD-10 code
O82
ICD-10 code description
Encounter for cesarean delivery without indication

Primary outcomes

1

Description
Pain score
Timepoint
At 1, 2, 4, 6, 12, and 24 h after the surgery
Method of measurement
Visual Analogue Scale (VAS)

2

Description
Nausea and vomiting,
Timepoint
At 1, 2, 4, 6, 12, and 24 h after the surgery
Method of measurement
Observation

3

Description
Shivering
Timepoint
At 1, 2, 4, 6, 12, and 24 h after the surgery
Method of measurement
Observation

4

Description
Headache
Timepoint
At 1, 2, 4, 6, 12, and 24 h after the surgery
Method of measurement
Observation

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: 40 patients received 15mg/kg iv. acetaminophen (diluted in 100 cc normal saline solution)
Category
Treatment - Drugs

2

Description
Intervention group: 40 patients received 0.5mg/kg iv meperidine
Category
Treatment - Drugs

3

Description
40 patients received 15mg/kg iv. acetaminophen + 0.5mg/kg meperidine within 15 minutes.
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Hafez hospital
Full name of responsible person
Zeinab Sadat Fattahi Saravi
Street address
Chamran boulevard , Hafez hospital
City
Shiraz
Province
Fars
Postal code
7134844119
Phone
+98 71 3647 4270
Email
parniafattahi@rocketmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Dr Seed Basir Hashemi
Street address
Vice chancellor of research,7th floor of central building of Shiraz University of Medical Sciences, Zand street
City
Shiraz
Province
Fars
Postal code
7134844119
Phone
+98 71 3647 4270
Email
masihifarzaneh@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shiraz University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic

Person responsible for general inquiries

Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Laleh Dehghanpishe
Position
Anesthesiologist
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Shahid Faghihi Hospital, Zand Street
City
Shiraz
Province
Fars
Postal code
7134844119
Phone
+98 71 3628 1460
Email
lalehdehghan@yahoo.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Zienab Sadat Fatahi Saravi
Position
Anesthesiologist
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Anesthesiology Department, Faghihi Hospital, Zand Street
City
Shiraz
Province
Fars
Postal code
713484419
Phone
+98 713436474270
Email
parniafattahi@rocketmail.com

Person responsible for updating data

Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Farzaneh Masihi
Position
MS in English Teaching, BS in anesthesia/English Consultant
Latest degree
Master
Other areas of specialty/work
Others
Street address
5th floor, Mohammad Rasoul Allah Research Tower, Khalili Street
City
Shiraz
Province
Fars
Postal code
713484419
Phone
+98 71 3647 4270
Email
masihifarzaneh@yahoo.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
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