Comparison of the effect of intrathecal Bupivacaine and Fentanyl with Bupivacaine and Dexmedetomidine on post operative pain of cesarean section in Shariati Hospital of Bandar Abbas in 2014
Background and Objective: Pain is one of the most common post-operative complications. In the case of cesarean section the post-operative pain can result in some complications for both Mother and neonate. Many methods have been proposed for the post-operative pain. Intrathecal opioid or dexmedetomedine injections are two examples of these methods. The aim of this study is to compare the efficacy of intrathecal fentanyl and dexmedetomedine for post-operative analgesia in cesarean sections that took place in Shariati Hospital of Bandar Abbass during 2014. Method: Randomized with 2 blocks design is considered. Double blinding design will be provided by concealing the awareness of the patients and the researcher who is in charge of data collection from the type of intervention. A total of 110 pregnant women who are scheduled for elective cesarean section divided into two groups randomly. Inclusion criteria: Women between 15 and 45 years old; Gestational age 37 week or higher; ASA 1-2. Exclusion criteria: Emergency patients; patients with contraindication for regional anesthesia; patients with Valvular Heart Disease; patients with history of Allergy to local anesthetic drugs; addiction or alcoholism; Placenta Previa; patients with incomplete spinal block who require analgesic agents. Intervention: Group A received 10 mg bupivacaine 0.5% plus dexmedetomedine 5 microgram; group B received 10 mg bupivacaine 0.5% plus fentanyl 25 microgram intrathecally. Main measurable variables: pain score, and motor block time.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2015052722449N1
Registration date:2015-11-02, 1394/08/11
Registration timing:retrospective
Last update:
Update count:0
Registration date
2015-11-02, 1394/08/11
Registrant information
Name
Mehdi Sharifi
Name of organization / entity
Hormozgan university of medical sciences
Country
Iran (Islamic Republic of)
Phone
+98 76 3334 5009
Email address
dr.msh53@yahoo.com
Recruitment status
Recruitment complete
Funding source
Vice chancellor for Research, Hormozgan University of Medical Sciences
Expected recruitment start date
2014-03-21, 1393/01/01
Expected recruitment end date
2015-03-20, 1393/12/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the effect of intrathecal Bupivacaine and Fentanyl with Bupivacaine and Dexmedetomidine on post operative pain of cesarean section in Shariati Hospital of Bandar Abbas in 2014
Public title
Comparison of the effect of Fentanyl with Dexmedetomidine on post operative pain of cesarean section
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Gestational age 37 weeks or higher; ASA I-II
Exclusion criteria: Emergency patients; patients with valvular Heart disease; patients with history of Allergy to local anesthetic drugs; addiction and alcoholism; placenta previa; patients with incomplete spinal block who require analgesic agents; patients with contraindication for regional anesthesia
Age
From 15 years old to 45 years old
Gender
Female
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
110
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Randomized with two-block design is considered. Double blinding design will be provided by concealing the awareness of the patients and the researcher who is in charge of data collection from the type of intervention.
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Hormozgan University of Medical Sciences
Street address
Shahid Mohammadi Hospital, Joomhoori Islami Blvd., Bandar Abbas, Iran
City
Bandar Abbas
Postal code
7919915519
Approval date
2014-09-30, 1393/07/08
Ethics committee reference number
3-HEC-93-7-8
Health conditions studied
1
Description of health condition studied
Complication of Anesthesia during pregnancy
ICD-10 code
029.8
ICD-10 code description
other Complication of Anesthesia during pregnancy
Primary outcomes
1
Description
Post operative pain
Timepoint
Recovery time and 1 - 3 - 6 hours after operation
Method of measurement
VAS (visual analogue scale)
2
Description
The duration of complete return of lower extremities movement (Modified Bromage Scale = 0)
Timepoint
Recovery time and 1 - 3 - 6 hours after operation
Method of measurement
Lower extremities movement (modified Bromage scale )
Secondary outcomes
1
Description
respiratory depression
Timepoint
For 6 hours after block initiation
Method of measurement
respiratory rate less than 10 per minute
2
Description
nausea and vomiting
Timepoint
For 6 hours after block initiation
Method of measurement
Questionnaire (Yes or NO)
3
Description
shivering
Timepoint
For 6 hours after block initiation
Method of measurement
Questionnaire (Yes or NO)
4
Description
blood pressure
Timepoint
Before injection and immediately after injection and at 5-10-15-30-60 minutes after injection and at recovery
Method of measurement
Automated sphygmomanometer
5
Description
heart rate
Timepoint
Before injection and immediately after injection and at 5-10-15-30-60 minutes after injection and at recovery
Method of measurement
heart rate monitoring device
Intervention groups
1
Description
Group 2: Intrathecal 10 mg bupivacaine 0.5% plus 25 microgram fentanyl
Category
Treatment - Drugs
2
Description
Group 1: Intrathecal 10 mg bupivacaine 0.5% plus 5 microgram dexmedetomidin
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Shariati Hospital
Full name of responsible person
Mehdi Sharifi
Street address
Shariati Hospital, Shahid Naser Blvd., Bandar Abbas, Iran
City
Bandar Abbas
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice Chancellor for Research, Hormozgan University of Medical Sciences
Full name of responsible person
Abdolazim Nejatizadeh
Street address
Vice chancellor for Research, Shahid Mohammadi Hospital, Joomhoori Islami blvd., Bandar Abbas, Iran
City
Bandar Abbas
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, Hormozgan 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
Hormozgan University of Medical Sciences
Full name of responsible person
Mehdi Sharifi
Position
Resident of Anesthesiology
Other areas of specialty/work
Street address
Shahid Mohammadi Hospital, Joomhoori Islami Blvd., Bandar Abbas, Iran
City
Bandar Abbas
Postal code
00987633347009
Phone
+98 76 3334 7009
Fax
Email
dr.msh53@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Hormozgan University of Medical Sciences
Full name of responsible person
Mehdi Sharifi
Position
Resident of Anesthesiology
Other areas of specialty/work
Street address
Shahid Mohammadi Hospital, Joomhoori Islami Blvd., Bandar Abbas, Iran
City
Bandar Abbas
Postal code
Phone
+98 76 3334 7009
Fax
Email
dr.msh53@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Hormozgan University of Medical Sciences
Full name of responsible person
Mehdi Sharifi
Position
Resident of Anesthesiology
Other areas of specialty/work
Street address
Shahid Mohammadi Hospital, Joomhoori Islami Blvd., , Bandar Abbas, Iran
City
Bandar Abbas
Postal code
Phone
+98 76 3334 7009
Fax
Email
dr.msh53@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)