1. Home
  2. Approved trials
  3. » فارسی

The effects of diclofenac suppository and intravenous acetaminophen, and the combination of them, on postoperative pain in patients undergoing spinal anesthesia for cesarean section

Protocol summary

Summary
This study is to evaluate of the effects of diclofenac suppository and intravenous acetaminophen, and the combination of them on postoperative pain in patients undergoing spinal anesthesia for cesarean section. Objectives: To investigate the effect of diclofenac suppository and Intravenous acetaminophen and the combination of them on the severity of postoperative pain in patients undergoing spinal anesthesia for cesarean section in Sayyad Shirazi health education center of Gorgan in 1393. Design: This study is randomized, double-blind. Setting and conduct: 90 patients scheduled for cesarean surgery will be randomly divided into three groups: A. 100 mg diclofenac suppositories, B.1000 mg intravenous acetaminophen, and C.50 mg of diclofenac suppositories and 500 mg intravenous acetaminophen. In the recovery, based on severity of pain measured by visual analogue scale (VAS), if the patients have moderate pain medication will be given. Main inclusion criterion: ASA class of 1 and 2, term gestational age. Main exclusion criteria: any allergies to medications such as acetaminophen and local anesthetics, liver and kidney diseases and diabetes. Interventions: Assessment of pain severity at 0, 2, 4, 6, 12, 24 and administration of nonsteroidal anti-inflammatory drug in three groups according to their average pain severity measured by (VAS). Main outcome measures: determination of pain severity in the groups.

General information

Acronym
-
IRCT registration information
IRCT registration number: IRCT201205099697N1
Registration date: 2015-01-27, 1393/11/07
Registration timing: registered_while_recruiting

Last update:
Update count: 0
Registration date
2015-01-27, 1393/11/07
Registrant information
Name
Fozieh Bakhsha
Name of organization / entity
Golestan University of Medical Science
Country
Iran (Islamic Republic of)
Phone
+98 17 3253 8011
Email address
bakhsha@goums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice Chancellor for Research and Technology, Golestan University of Medical Sciences
Expected recruitment start date
2014-04-03, 1393/01/14
Expected recruitment end date
2015-05-04, 1394/02/14
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effects of diclofenac suppository and intravenous acetaminophen, and the combination of them, on postoperative pain in patients undergoing spinal anesthesia for cesarean section
Public title
Assessment of the effects of diclofenac suppository and intravenous acetaminophen, and the combination of them, on postoperative pain in patients undergoing spinal anesthesia for cesarean section
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Patients with 1 and 2 ASA class of Anesthesia; Term gestational age; absence of chronic diseases such as cardiovascular; hepatic and renal disease. exclusion criteria: hypersensitivity to any drug such as acetaminophen; local anesthetics, having liver or renal disease; diabetes, and patients who used analgesic drugs (opioids, NSAID and corticosteroid)within 8 to 12 hours before the intervention
Age
From 17 years old to 40 years old
Gender
Female
Phase
3
Groups that have been masked
No information
Sample size
Target sample size: 90
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Samples receiving medicine will be divided into three groups with simple random sampling method.

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Golestan University Of Medical Sciences
Street address
km 4 road Sari Gorgan, Vice Chancellor for Research and Technology, Golestan University of Medical Sciences, Gorgan, Golestan province, Iran
City
Gorgan
Postal code
49341-74515
Approval date
2014-03-02, 1392/12/11
Ethics committee reference number
36439212016

Health conditions studied

1

Description of health condition studied
َAcute Pain
ICD-10 code
R52.0
ICD-10 code description
َAcute Pain

Primary outcomes

1

Description
Determination of pain severity before intervention in patients undergoing spinal anesthesia for cesarean section in diclofenac suppository group in Sayyad Shirazi Hospital of Gorgan
Timepoint
before intervention
Method of measurement
Visual Analogue Scale (VAS)

2

Description
Determination of pain severity before intervention in patients undergoing spinal anesthesia for cesarean section in intravenous acetaminophen group in Sayyad Shirazi Hospital of Gorgan
Timepoint
before intervention
Method of measurement
Visual Analougue Scale(VAS)

3

Description
Determination of pain severity before intervention in patients undergoing spinal anesthesia for cesarean section in combination of the intravenous acetaminophen and diclofenac suppository group in Sayyad Shirazi Hospital of Gorgan
Timepoint
before intervention
Method of measurement
Visual Analougue Scale (VAS)

4

Description
Determination of pain severity after intervention in patients undergoing spinal anesthesia for cesarean section in group of diclofenac suppository in Sayyad Shirazi Hospital of Gorgan
Timepoint
in hour 0, 2, 4, 6, 12, 24
Method of measurement
Visual Analougue Scale

5

Description
Determination of pain severity after intervention in patients undergoing spinal anesthesia for cesarean section in group of intravenous acetaminophen in Sayyad Shirazi Hospital of Gorgan
Timepoint
in hour 0, 2, 4, 6, 12,24
Method of measurement
Visual Analougue Scale (VAS)

6

Description
Determination of pain severity after intervention in patients undergoing spinal anesthesia for cesarean section in combination of the intravenous acetaminophen and diclofenac suppository group in Sayyad Shirazi Hospital of Gorgan
Timepoint
in hour 0، 2 ،4 ،6 ،12، 24
Method of measurement
Visual Analougue Scale (VAS)

7

Description
Comparison of pain severity after the intervention in patients undergoing spinal anesthesia for cesarean section groups of acetaminophen, diclofenac, and the combined intravenous acetaminophen and diclofenac suppository in Sayyad Shirazi Hospital of Gorgan
Timepoint
in hour 0, 2, 4, 6, 12, 24
Method of measurement
Visual Analougue Scale (VAS)

Secondary outcomes

empty

Intervention groups

1

Description
Diclofenac suppositories 100 mg, based on average pain severity of patients evaluated at Hour 0, 2, 4, 6, 12, 24 after local anesthetic in the recovery unit, will be prescribed. Aboureihan Pharmaceutical product
Category
Treatment - Drugs

2

Description
intravenous acetaminophen 1000mg، based on average pain severity of patients evaluated at Hour 0, 2, 4, 6, 12, 24 after local anesthetic in the recovery unit, will be prescribed. Daroupakhsh Pharmaceutical product
Category
Treatment - Drugs

3

Description
Combination of diclofenac suppository 100 mg and 500 mg intravenous acetaminophen, based on average pain severity of patients at hour 0, 2, 4, 6, 12, 24 post-local anesthetic in recovery unit, will be prescribed. Aboureihan and DarouPakhsh pharmaceutical products
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Sayyad Shirazi Hospital of Gorgan
Full name of responsible person
Fozieh Bakhsha, MSc Anesthesiology, Academic staff Instructor, Director of Department Anesthesiology
Street address
Department of Anesthesiology, Faculty of Paramedical Sciences, Golestan University of Medical Sciences, Km 4 road Sari-Gorgan, Gorgan, Golestan province, Iran n
City
Gorgan

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Golestan University of Medical Sciences
Full name of responsible person
Masoud khoshnia, Director of Vice Chancellor Research and Technology
Street address
Vice Chancellor for Research and Technology, Golestan University of Medical Sciences, km 4 road Sari Gorgan, Gorgan, Golestan province, Iran
City
Gorgan
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Golestan 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
Golestan University of Medical Sciences
Full name of responsible person
Fozieh Bakhsha
Position
MSc in Anesthesia,Instracter of Paramedical School
Other areas of specialty/work
Street address
Department of Anesthesiology, Faculty of Paramedical Sciences, Golestan University of Medical Sciences, Km 4 road Sari-Gorgan, Gorgan, Golestan province, Iran
City
Gorgan
Postal code
74515-49341
Phone
+98 17 3253 8011
Fax
+98 9901432423630
Email
Bakhsha2goums.ac.ir؛ Bakhsha_fo@yahoo.com؛ Bakhshafo@gmail .com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Golestan University of Medical Sciences
Full name of responsible person
Fozieh Bakhsha
Position
MSc in Anesthesia, Instructor of Paramedics
Other areas of specialty/work
Street address
km 4 road Sari Gorgan, Vice Chancellor for Research and Technology, Golestan University of Medical Sciences, Gorgan, Golestan province, Iran
City
Gorgan
Postal code
74515-49341
Phone
+98 17 3253 8011
Fax
Email
Bakhsha2goums.ac.ir؛ Bakhsha_fo@yahoo.com؛ Bakhshafo@gmail .com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Golestan University of Medical Sciences
Full name of responsible person
Fozieh Bakhsha
Position
MSc in Anesthesia, Instructor of Paramedics
Other areas of specialty/work
Street address
km 4 road Sari Gorgan, Vice Chancellor for Research and Technology, Golestan University of Medical Sciences, Gorgan, Golestan province, Iran
City
Gorgan
Postal code
74515-49341
Phone
+98 17 3253 8011
Fax
Email
Bakhsha@goums.ac.ir; Bakhsha_fo@yahoo.com; Bakhshafo@gmail.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
Loading...