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The effect of low-dose intravenous ketamine on shoulder pain following caesarean section under spinal anesthesia

Protocol summary

Summary
Background:Prevalence of shoulder pain is more common in cesarian section than natural vaginal delivery, and in cases in which spinal anesthesia is used is more commonly seen. If an anti-pain drug is used before the stimulant, it can reduce severity of pain and usage of painkillers. Ketamine is one of the successful painkillers in reducing pain. This study was performed in order to evaluate effect of low dose ketamine on shoulder pain followed by cesarean section.Inclusion criteria: pregnant women who based on american society of anesthesiologists classification did not have any other organic biochemical or psychiatric disease and were aged between 15-40 years old, and were candidate for selective cesarean section under spinal anesthesia. Exclusion criteria:scientific contraindications(pre-eclampsia,eclampsia,primary hypertension,high intra-cranial pressure due to any cns pathology such as head trauma, brain tumor,recent cerebrovascular accidents),history of addiction,history of allergic reactions to ketamine,history of chronic pain,fracture or trauma to upper limb or shoulder. Methods: In this randomized double-blind study being performed in 2016,a group of 40 pregnant women were selected for intervention and a group of 40 was selected as the control group. All the women met the inclusion criteria. Control group received 5 CC of the pure water as placebo and the second group received 0/5 mg/kg interavenus ketamine in order to evaluate the effect of ketamine in reducing the shoulder pain after cesarean section.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2016041627242N2
Registration date: 2016-07-06, 1395/04/16
Registration timing: registered_while_recruiting

Last update:
Update count: 0
Registration date
2016-07-06, 1395/04/16
Registrant information
Name
Manizhe Yousefi moghadam
Name of organization / entity
Sabzevar univerity of medical sciences
Country
Iran (Islamic Republic of)
Phone
+98 51 4422 8595
Email address
yousefim1@medsab.ac.ir
Recruitment status
Recruitment complete
Funding source
Sabzevar University Of Medical Sciences
Expected recruitment start date
2016-04-18, 1395/01/30
Expected recruitment end date
2016-08-27, 1395/06/06
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of low-dose intravenous ketamine on shoulder pain following caesarean section under spinal anesthesia
Public title
The effect of low-dose intravenous ketamine on shoulder pain
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: pregnant women wich age is between 15-40 ywers old, and will be c/s under spinal anastesia Exclusion criteria: Interdict scientific forbide(rise ICP; eklampsy; pereklampsy; head truma; primery hypertension; brain tumor;cerebrovascular accsident in past); addiction; sensivity to ketamine; cronic shulder pain; history of psychiatric disease; pregnancy hypertension; history of fracture;
Age
No age limit
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 80
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
Sabzevar Univercity Of Medical Science
Street address
Setad Markazi,besid the Heshmatieh hospital,Asadabadi street,Sabzevar
City
Sabzevar
Postal code
Approval date
2015-08-03, 1394/05/12
Ethics committee reference number
ir.medsab.rec.1394.63

Health conditions studied

1

Description of health condition studied
The effect of ketamin on shoulder pain
ICD-10 code
y48.2
ICD-10 code description
Other and unspecified general anaesthetics

Primary outcomes

1

Description
Shoulder pain
Timepoint
After intervention in first 24 hour
Method of measurement
Visual analog scale

Secondary outcomes

1

Description
Hallucination
Timepoint
After interventin in first 3 hour
Method of measurement
Taking history

Intervention groups

1

Description
All the patients in the intervention group receive 500-1000 cc of ringer before performing spinal anesthesia.Before spinal anesthesia standard monitoring including blood pressure(systolic and diastolic),heart rate and pulse oxymetry is performed for the intervention group.Spinal anesthesia is performed by 2.5 cc bupivacaine and hyperbaric oxygen 0.5% .The intervention group receives ketamine 2/0 mg/kg iv after spinal anesthesia and before performing the cesarian section. Ketamin and pure water are stored in same 5 cc syringes and are coded by the technician.The anesthesiologist and the technician are not aware of consistence of the syringes.
Category
Treatment - Drugs

2

Description
All the patients in control group receive 500-1000 cc of ringer before performing spinal anesthesia.Before spinal anesthesia standard monitoring including blood pressure(systolic and diastolic),heart rate and pulse oxymetry is performed for the control group.Spinal anesthesia is performed by 2.5 cc bupivacaine and hyperbaric oxygen 0.5%.The control group receives 5 cc of pure water. Ketamin and pure water are stored in same 5 cc syringes and are coded by the technician.The anesthesiologist and the technician are not aware of consistence of the syringes.
Category
Treatment - Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Sabzevar Shahidane Mobini hospital
Full name of responsible person
Solmaz Dastras
Street address
number 10 aref street
City
sabzevar

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Sabzevar University of Medical Sciences
Full name of responsible person
Mohamad Mohamadzade
Street address
Mobini hospital, Kashefi street
City
sabzevar
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Sabzevar 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
Sabzevar University of Medical Sciences
Full name of responsible person
Solmaz dastras
Position
Bacheller
Other areas of specialty/work
Street address
Number 10 aref street
City
Sabzevar
Postal code
Phone
+98 51 4421 7383
Fax
Email
Solmazdastras@yahoo.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Sabzevar University of Medical Sciences
Full name of responsible person
Manizheh Yoosefi moghadam
Position
Anesthiologist
Other areas of specialty/work
Street address
Mobini hospital, Kashefi street
City
Sabzevar
Postal code
Phone
+98 51 4423 8100
Fax
Email
Yousefim1@medsab.ac.ir
Web page address

Person responsible for updating data

Contact

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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