Comparative study of the duration of analgesia following spinal anesthesia with lidocaine 5% with fentanyl and marcain in pregnant women under cesarean section
Objective: To compare the duration of analgesia after spinal anesthesia with lidocaine 5% with fentanyl and Marcaine in pregnant women undergoing caesarean section study design: non-randomized, double-blind (Patient and investigator), without control mode, single-center, Phase 2 clinical trial
Study population: Non-emergency pregnant patients refer to caesarean section.
Major inclusion criteria: Non-emergency pregnancy patients referred for cesarean section. Main Exclusion criteria: People with a history of diabetes, addiction, sedation And psychotropic drugs.
Sample size: 200 patients
Intervention: Effect of marcaine and lidocaine 5% with fentanyl on the duration of return of pain level in pregnant mothers under spinal anesthesia.
Intervention time: initiation of cesarean section.
Outcome: Effect of Lidocaine 5% with fentanyl and marcaine is different in duration of analgesia following spinal anesthesia in pregnant women under cesarean section.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201707157745N9
Registration date:2017-08-12, 1396/05/21
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2017-08-12, 1396/05/21
Registrant information
Name
Afshin Mansourian
Name of organization / entity
YUMS
Country
Iran (Islamic Republic of)
Phone
+98 74 3322 0620
Email address
afshin.mansourian@yahoo.com
Recruitment status
Recruitment complete
Funding source
Investigator
Expected recruitment start date
2017-02-03, 1395/11/15
Expected recruitment end date
2017-09-11, 1396/06/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparative study of the duration of analgesia following spinal anesthesia with lidocaine 5% with fentanyl and marcain in pregnant women under cesarean section
Public title
Clinical trial comparing lidocaine 5% with fentanyl and Marcaine on the duration of spinal anesthesia in pregnant women
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Pregnant patients who come to the operating room for non-emergency c/s.
Exclusion criteria: patients with a history of diabetes, addiction, drugs are sedatives and psychoactive drugs.
Age
No age limit
Gender
Female
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
200
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
In this study, the satisfaction of mothers with surgery was studied in both groups.
Secondary Ids
1
Registry name
-
Secondary trial Id
-
Registration date
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Deputy of Research and Technology of YUMS
Street address
Yasuj University of Medical Sciences
City
Yasuj
Postal code
Approval date
2010-09-23, 1389/07/01
Ethics committee reference number
IR.YUNS.REC.1395.221
Health conditions studied
1
Description of health condition studied
Spinal Anesthesia in pregnant patient
ICD-10 code
XV
ICD-10 code description
094-099
2
Description of health condition studied
Spinal Anesthesia in pregnant patient
ICD-10 code
XV
ICD-10 code description
094-099
Primary outcomes
1
Description
the duration of analgesia after spinal anesthesia with lidocaine 5% with fentanyl and Marcaine in pregnant women undergoing cesarean section.
Timepoint
5 minutes after completion of caesarean section, Back pain at the site of action
Method of measurement
Touch the place
Secondary outcomes
1
Description
Satisfaction and a pleasant feeling by the mother
Timepoint
After the surgery and recovery time
Method of measurement
Ask the patient and see the clinical symptoms
Intervention groups
1
Description
Marcaine injected in the subarachnoid space in a single dose, 4 mg
Category
Treatment - Drugs
2
Description
We use two drugs in this study.
Lidocaine 5%: injection in the subarachnoid space as a single dose of 75 mg
Fentanyl: injection in the subarachnoid space as a single dose ,50 macro grams
Marcaine: injected in the subarachnoid space as a single dose, 4 mg
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Sajjad Hospital
Full name of responsible person
Dr. Afshin Mansourian
Street address
Shahid Behashti haspital
City
Yasuj
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research, YUMS
Full name of responsible person
Dr Hossein Ariad
Street address
YUMS
City
Yasuj
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, YUMS
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
YUMS
Full name of responsible person
DR.Afshin Mansourian
Position
Anesthesiologist / Assistant Professor
Other areas of specialty/work
Street address
Imam Sajjad Hospital
City
Yasuj
Postal code
Phone
+98 74 3322 0166
Fax
Email
afshin.mansourian@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
YUMS
Full name of responsible person
DR. Afshin Mansourian
Position
Anesthesiologist/Assistant Professor
Other areas of specialty/work
Street address
Imam Sajjad Hospital
City
Yasuj
Postal code
Phone
+98 74 3322 0166
Fax
Email
afshin.mansourian@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
YUMS
Full name of responsible person
DR. Afshin mansourian
Position
Anesthesiologist / Assistant Professor
Other areas of specialty/work
Street address
Imam Sajjad Hospital
City
Yasuj
Postal code
Phone
+98 74 3322 0166
Fax
Email
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)