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The effect of subcutaneous ketamine infiltration on postoperative pain in elective cesarean section under spinal anesthesia.

Protocol summary

Summary
This is randomized double blind clinical trial (phase 2) with placebo that is done in 60 parturient 15 -45 years with ASA class 1&2 candidate for cesarean section under spinal anesthesia. Patients with history of hypertension; hyperthyroidism; convulsion; symptoms of increasing ICP; psychiatric disorders; ischemic heart disease; valvular heart disease; Ketamin allergy; liver & renal failure; alcohol or drugs abuse; spinal anesthesia contraindications(patients refuse, coagulation disorders, local infections, neurologic disorders, severe anemia,...); spinal failure & general anesthesia is excluded. In all patients after receiving 500 ml serum ringer and spinal anesthesia with 12.5 mg Bupivacain 0.5% cesarean section is done. After closure perituine in K group 0.5mg/kg(0.05ml/kg) ketamin and in P group (0.05ml/kg) normal saline subcutaneously is infiltrated.VAS of pain, BP, PR, RR & SPO2 in pre administration of drug , arrival to recovery , 30 minutes after staying in recovery, delivery time of recovery and 2, 4, 6, 8, 12 and 24 hours after surgery by nursing is measured.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2013031710841N4
Registration date: 2013-04-22, 1392/02/02
Registration timing: registered_while_recruiting

Last update:
Update count: 0
Registration date
2013-04-22, 1392/02/02
Registrant information
Name
Nahid Manuchehrian
Name of organization / entity
Hamedan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 81 1827 7012
Email address
manouchehrian@umsha.ac.ir
Recruitment status
Recruitment complete
Funding source
Hamadan University Of Medical Sciences
Expected recruitment start date
2013-03-21, 1392/01/01
Expected recruitment end date
2013-09-22, 1392/06/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of subcutaneous ketamine infiltration on postoperative pain in elective cesarean section under spinal anesthesia.
Public title
Ketamin on reducing postoperative pain in cesarean section
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: age between15-45 years old;ASA class 1&2; parturition candidate for cesarean section under spinal anesthesia. Exclusion criteria: history of hypertension; hyperthyroidism; convulsion; symptoms of increasing ICP ; psychiatric disorders; ischemic heart disease; valvular heart disease; allergy to Ketamin; liver & renal failure; alcohol or drugs abuse; spinal anesthesia contraindications(patients refuse, coagulation disorders, local infections, neurologic disorders, sever anemia,...) ; spinal failure & general anesthesia for surgery.
Age
From 15 years old to 45 years old
Gender
Female
Phase
2
Groups that have been masked
No information
Sample size
Target sample size: 60
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
Hamadan University Of Medical Sciences
Street address
Hamadan University Of Medical Sciences,Medical School,Fahmide Street
City
Hamadan
Postal code
65178
Approval date
2012-11-22, 1391/09/02
Ethics committee reference number
3041/9/35/16/پ/د

Health conditions studied

1

Description of health condition studied
cesarean postoperative pain
ICD-10 code
089.9
ICD-10 code description
Complication of anaesthesia during the puerperium, unspecified

Primary outcomes

1

Description
Diastolic Blood Pressure
Timepoint
before drug adminstration; arrive to recovery; 30 minutes after stay in recovery;exit from recovery; 2, 4, 6, 8, 12 & 24 hours after sergury.
Method of measurement
Non invasive Blood Pressure Monitoring

2

Description
Pain score
Timepoint
before drug adminstration; arrive to recovery; 30 minutes after stay in recovery;exit from recovery; 2, 4, 6, 8, 12 & 24 hours after sergury.
Method of measurement
10 centimeter ruller

3

Description
Systolic Blood Pressure
Timepoint
before drug adminstration; arrive to recovery; 30 minutes after stay in recovery;exit from recovery; 2, 4, 6, 8, 12 & 24 hours after sergury.
Method of measurement
Non invasive Blood Pressure Monitoring

4

Description
Heart rate
Timepoint
before drug adminstration; arrive to recovery; 30 minutes after stay in recovery;exit from recovery; 2, 4, 6, 8, 12 & 24 hours after sergury.
Method of measurement
Non invasive Blood Pressure Monitoring

5

Description
Respiratory rate
Timepoint
before drug adminstration; arrive to recovery; 30 minutes after stay in recovery;exit from recovery; 2, 4, 6, 8, 12 & 24 hours after sergury.
Method of measurement
Observation & Examination

6

Description
Blood oxygenation
Timepoint
before drug adminstration; arrive to recovery; 30 minutes after stay in recovery;exit from recovery; 2, 4, 6, 8, 12 & 24 hours after sergury.
Method of measurement
Non invasive Blood Pressure Monitoring

7

Description
Analgesic requirement in 24 hours
Timepoint
During 24 hours
Method of measurement
Observation & calculation

Secondary outcomes

1

Description
Nausea
Timepoint
Preadminstration, arrive to recovery, 30 minutes after stay in recovery,exit of recovery, 2- 4- 6- 8- 12 & 24 hours after sergury
Method of measurement
Observation

2

Description
Hallosination
Timepoint
Preadminstration, arrive to recovery, 30 minutes after stay in recovery,exit of recovery, 2- 4- 6- 8- 12 & 24 hours after sergury
Method of measurement
Observation &Examination

3

Description
Nistagmus
Timepoint
Preadminstration, arrive to recovery, 30 minutes after stay in recovery,exit of recovery, 2- 4- 6- 8- 12 & 24 hours after sergury
Method of measurement
Observation &Examination

4

Description
Sedation Level
Timepoint
pPreadminstration, arrive to recovery, 30 minutes after stay in recovery,exit of recovery, 2- 4- 6- 8- 12 & 24 hours after sergury
Method of measurement
Ramsay Scale

5

Description
Vomiting
Timepoint
Preadminstration, arrive to recovery, 30 minutes after stay in recovery,exit of recovery, 2- 4- 6- 8- 12 & 24 hours after sergury
Method of measurement
Observation

Intervention groups

1

Description
After closure perituine in K group 0.5mg/kg(0.05ml/kg) ketamin subcutaneously is infiltrated and patient is transferd to recovery room.
Category
Prevention

2

Description
After closure perituine in P group (0.05ml/kg) normal salin subcutaneously is infiltrated and patient is transfered to recovery room.
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Fatemieh Hospital
Full name of responsible person
Nahid Manouchehrian
Street address
Fatemieh Hospital ,Pasdaran Street
City
Hamadan

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Hamadan University Of Medical Science ,Vice chancellor for research
Full name of responsible person
Dr. Heidar Tavilany
Street address
Hamadan University Of Medical Science,Medical School,Fahmide Street
City
Hamadan
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Hamadan University Of Medical Science ,Vice chancellor for research
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
Hamadan University of Medical Science
Full name of responsible person
Nahid Manouchehrian
Position
Assistant Professor Of Hamadan University of Medical Science
Other areas of specialty/work
Street address
Fatemieh Hospital,Pasdaran Street
City
Hamadan
Postal code
65177-8-9971
Phone
+98 81 1827 7012
Fax
+98 81 1828 3939
Email
fatemieh@umsha.ac.ir
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Hamadan University Of Medical Science
Full name of responsible person
Nahid Manouchehrian
Position
Board of Anesthesia
Other areas of specialty/work
Street address
Fatemieh Hospital,Pasdaran Street
City
Hamadan
Postal code
65177-8-9971
Phone
+98 81 1827 7012
Fax
+98 81 1828 3939
Email
manouchehrian@umsha.ac.irnmanuchehrian@yahoo.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Hamadan University Of Medical Science
Full name of responsible person
Nahid Manouchehrian
Position
Anesthesia Assistant Professor Of Hamadan University Of Medical Sciences
Other areas of specialty/work
Street address
Fatemieh Hospital,Pasdaran Street
City
Hamadan
Postal code
65177-8-9971
Phone
+98 81 1827 7012
Fax
+98 81 1828 3939
Email
manouchehrian@umsha.ac.irnmanuchehrian@yahoo.com
Web page address

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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