Protocol summary

Summary
Objectives: To assess the effect of combination of the dexamethasone with local anesthetics and narcotics on enhancing the duration of painlessness and reducing the need for intravenous drugs for post cesarean pain control. Research Design: Conduction of a randomized, double-blind, clinical trial, method of randomization: simple randomization by computer . Inclusion criteria: women with a gestational age of 38-42 weeks; ASA I and II and literate. Exclusions criteria: pregnant woman who had received any analgesics during the prior 48 hours; addiction to the drugs ; hypersensitive to the administered drugs (lidocaine, dexamethasone, morphine); positive history of mental illness. Interventions: The parturients were divided into three equal groups to receive either 70 mg lidocaine intrathecally or 70 mg lidocaine combined with 0.15 mg morphine, or the latter regimen combined with 4 mg dexamethasone. For the first group, spinal anesthesia was done by using 70 mg lidocaine and no intravenous or intramuscular analgesics, or any other intrathecal drug. In the second group, we used 70 mg lidocaine in combination with 0.15 mg morphine 70 mg lidocaine, 0.15 mg morphine, and 4 mg dexamethasone were used for the third group,. Various variables such as pain intensity and amount of morphine administered as well as neonates' Apgar scores and duration of stay in the recovery room were compared between the three groups.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2015060819470N22
Registration date: 2015-08-06, 1394/05/15
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2015-08-06, 1394/05/15
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
Vice Chancellor for Research, Shiraz University of Medical Science
Expected recruitment start date
2009-01-01, 1387/10/12
Expected recruitment end date
2009-07-01, 1388/04/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
A Clinical Trial to Assess the Effect of Combination of Interathecal Dexamethasone with Lidocaine and Narcotics on Post Cesarean Section Pain
Public title
The Effect of l Dexamethasone on Post Cesarean Section Pain
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: women with a gestational age of 38-42 weeks; ASA I and II; literate. Exclusions criteria: pregnant woman who had received any analgesics during the prior 48 hours; addiction to the drugs ; hypersensitivity to the administered drugs (lidocaine, dexamethasone, morphine); positive history of mental illness.
Age
No age limit
Gender
Female
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size: 60
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethic Committee of Shiraz University Of Medical Sciences
Street address
Central Building of Shiraz University of Medical Sciences, Zand Street
City
Shiraz
Postal code
Approval date
2010-08-20, 1389/05/29
Ethics committee reference number
CP-P-9334-1124

Health conditions studied

1

Description of health condition studied
Cesarean
ICD-10 code
032.5
ICD-10 code description
Maternal care for multiple gestation with malpresentation of one fetus or more

Primary outcomes

1

Description
postoperative pain
Timepoint
At 4 ,8,12,24 hours after surgery
Method of measurement
NRS(Numerical Rating Scale)

Secondary outcomes

1

Description
Apgar
Timepoint
At the first and fifth min after birth
Method of measurement
Apgar Scoring

Intervention groups

1

Description
70 mg lidocaine intrathecally for spinal anesthesia
Category
Treatment - Drugs

2

Description
70 mg lidocaine combined with 0.15 mg morphine for spinal anesthesia
Category
Treatment - Drugs

3

Description
70 mg lidocaine with 4 mg dexamethasone for spinal anesthesia
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Zeinabieh Teaching Hospital
Full name of responsible person
Behzad Maghsodi
Street address
Defae Moghadas square, Zeinabieh Teaching Hospital
City
Shiraz

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice Chancellor for Research, Shiraz University of Medical S
Full name of responsible person
Dr Seed Basir Hashemi
Street address
Vice Chancellor for Research ,Shiraz University of Medical Sciences-7th floor-Central Building of Shiraz University of Medical Sciences , Zand Street
City
Shiraz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice Chancellor for Research, Shiraz University of Medical S
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
Shiraz University of Medical Sciences
Full name of responsible person
Behzad Maghsodi
Position
Physician, Anesthesiologist
Other areas of specialty/work
Street address
Anesthesiology Department, Shahid Faghihi Hospital, Zand street
City
Shiraz
Postal code
Phone
+98 71 3647 4270
Fax
Email
maghsodb@yahoo.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Shiraz University Of Medical Sciences
Full name of responsible person
Behzad Maghsodi
Position
Cardio-Anesthesilogist
Other areas of specialty/work
Street address
Anesthesiology Department, Faghihi Hospital, Zand Street
City
Shiraz
Postal code
Phone
+98 9871364774270
Fax
Email
maghsodb@yahoo.com
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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