Comparison of intravenous paracetamol and ketorolac for prevention of intra-operative shoulder pain in patients undergoing cesarean section under spinal anesthesia
Comparison of the pre-emptive analgesic effect of intravenous paracetamol and ketorolac for prevention of intra-operative shoulder pain in patients undergoing cesarean section under spinal anesthesia
Design
Double Blinded Randomized Clinical Trial
Settings and conduct
In this study , 300 patient in 3 groups in a double-blind placebo-controlled clinical trial will undergo cesarean section at Hafez hospital ,Shiraz.
Participants/Inclusion and exclusion criteria
Inclusion criteria: primi-gravid or second gravid; elective cesarean section (ASA I-II) who have singleton term pregnancy (37 weeks of gestational age or more).
Non-inclusion criteria:, hepatic disorders, renal insufficiency, chronic alcoholism, chronic pains, history of peptic ulcer disease, history of abdominal surgery any contraindication to spinal anesthesia.
Intervention groups
Intervention group 1: patients in the ketorolac group will receive 30 mg of ketorolac in 100 cc normal saline during 20 minutes.
Intervention group 2: patients in the paracetamol group will receive preventive paracetamol, 1000 mg in 100 cc normal saline during 20 minutes.
Control group: Patients in the control group will receive 100 cc normal saline as placebo during 20 minutes.
Main outcome variables
Shoulder Pain; Blood pressure; Heart rate
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20180922041084N4
Registration date:2019-10-21, 1398/07/29
Registration timing:prospective
Last update:2019-10-21, 1398/07/29
Update count:0
Registration date
2019-10-21, 1398/07/29
Registrant information
Name
Maryam Tabibzadeh
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 71 3628 1460
Email address
dpt2370349433@sums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-10-22, 1398/07/30
Expected recruitment end date
2020-01-20, 1398/10/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of intravenous paracetamol and ketorolac for prevention of intra-operative shoulder pain in patients undergoing cesarean section under spinal anesthesia
Public title
The effect of intravenous paracetamol and ketorolac for prevention of intraoperative shoulder pain
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
primi-gravid or second gravid
elective cesarean section (ASA I-II) who have singleton pregnancy at term (37 weeks of gestational age or more
singleton pregnancy
37 weeks of gestational age or more
Exclusion criteria:
allergy to ketorolac and other NSAIDs
allergy to paracetamol
asthma
gestational diabetes
cardiovascular disorders
hepatic disorders
renal insufficiency
chronic alcoholism
per-eclampsia
bleeding tendency
chronic pain
history of upper extremity trauma
history of peptic ulcer disease
history of abdominal surgery
any contraindication to spinal anesthesia
spinal column fracture
Age
From 18 years old to 45 years old
Gender
Both
Phase
2-3
Groups that have been masked
Participant
Investigator
Outcome assessor
Data analyser
Sample size
Target sample size:
150
Randomization (investigator's opinion)
Randomized
Randomization description
Patients are randomized according to the charts which is derived from www.randomization.com site.
Blinding (investigator's opinion)
Double blinded
Blinding description
Neither the participants nor the investigators involved in data collection and assessing the outcomes are aware of the identity of the target drugs used in the study.
Placebo
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, 7th floor, Shiraz University of Medical Sciences, central building of Shiraz University of Medical Sciences, Zand street
City
Shiraz
Province
Fars
Postal code
7134844119
Approval date
2018-12-03, 1397/09/12
Ethics committee reference number
IR.SUMS.MED.REC.1397.358
Health conditions studied
1
Description of health condition studied
cesarean delivery
ICD-10 code
O82.9
ICD-10 code description
Delivery by caesarean section, unspecified
Primary outcomes
1
Description
shoulder pain
Timepoint
Before the surgery as baseline measurement and intra-operatively
Method of measurement
numerical rating scale (NRS)
2
Description
Blood pressure
Timepoint
Every five minutes till 20 minutes after spinal anesthesia and the every 10 minutes to the end of the surgery.
Method of measurement
Monitoring
3
Description
Heart rate
Timepoint
Every five minutes till 20 minutes after spinal anesthesia and the every 10 minutes to the end of the surgery.
Method of measurement
Monitoring
Secondary outcomes
1
Description
Hematocrit
Timepoint
Before and after surgery
Method of measurement
Blood sample
Intervention groups
1
Description
Intervention group 1: patients in the ketorolac group will receive 30 mg of ketorolac in 100 cc normal saline during 20 minutes.
Category
Treatment - Drugs
2
Description
Intervention group 2: patients in the paracetamol group will receive preemptive paracetamol 1000 mg in 100 cc normal saline during 20 minutes.
Category
Treatment - Drugs
3
Description
Control group: Patients in the control group will receive 100 cc normal saline as placebo during 20 minutes.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Hafez Hospital
Full name of responsible person
Farnaz Faiz
Street address
At the beginning of Abirverdi Street, Chamran street
City
Shiraz
Province
Fars
Postal code
۳۴۷۸۶-۷۱۹۴۶
Phone
+98 71 3647 4270
Email
ffeiz1984@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Dr.Younes Ghasemi
Street address
Vice Chancellor of research, 7th floor, central building of Shiraz University of Medical Sciences, Zand street
City
Shiraz
Province
Fars
Postal code
7134844119
Phone
+98 71 3647 4270
Email
drtabib.maryam@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
Farnaz Faiz
Position
Anesthesiology resident/physician
Latest degree
Medical doctor
Other areas of specialty/work
Anesthesiology
Street address
Anesthesiology Department, Faghihi Hospital, Zand Street
City
Shiraz
Province
Fars
Postal code
7134844119
Phone
+98 71 3647 4270
Email
ffeiz1984@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
laleh Dehghan Pishe
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
7134844119
Phone
+98 71 3647 4270
Email
lalehdehghan@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Maryam tabibzadeh
Position
Medical Doctor
Latest degree
Medical doctor
Other areas of specialty/work
Others
Street address
5th floor, Mohammad Rasoul Allah Research Tower, Khalili Street
City
Shiraz
Province
Fars
Postal code
7134844119
Phone
+98 910 718 3846
Email
drtabib.maryam@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