Evaluation of the effect of oxytocin on postoperative pain in patients undergoing cesarean section anesthesia
Design
patients divided into two groups A and B. (30 people in each group).
1.To control bleeding after placental abruption in group A, oxytocin 20 units in normal saline is injected at a rate of 10 cc per minute. If the patient needs uterotonic drug, 0.2 mg metrogen or 400 sublingual misoprostol is used. Group A will not receive oxytocin in prescription sera.
2. To control bleeding after placental abruption in group B, oxytocin is injected 20 units in normal saline at a rate of 10 cc per minute. If the patient needs, uterotonic contraceptive drug (0.2 mg of metrogen or misoprostol 400 sublingually) is given. Group B 10 units of normal saline will be added to the prescribed serums every 8 hours immediately after the operation. A total of 30 units in 24 hours).
Settings and conduct
Patients referred to Kosar Hospital in Qazvin for cesarean section are studied, then patients are divided into two groups A and B based on a table of computer random numbers (30 people in each group).
This study will be performed in a double-blind manner.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Patients referred to Kosar Hospital in Qazvin for cesarean section/
Exclusion Criteria: History of chronic pain and analgesic use, bleeding or coagulation disorder, peptic ulcer, renal or hepatic insufficiency and asthma, uterine atony, twins, placenta previa, Placental abruption, accreta placenta
Intervention groups
In the intervention group, immediately after cesarean section, 10 units of oxytocin will be added to the prescribed serums every 8 hours per liter of normal saline (30 units in 24 hours).
Main outcome variables
Pain relief
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20190905044705N1
Registration date:2021-12-23, 1400/10/02
Registration timing:registered_while_recruiting
Last update:2021-12-23, 1400/10/02
Update count:0
Registration date
2021-12-23, 1400/10/02
Registrant information
Name
Mohammadmahdi Mir Nasseri
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 4432 1888
Email address
mirnasseri@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-12-06, 1400/09/15
Expected recruitment end date
2022-03-01, 1400/12/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The analgesic effects of Oxytocin in women undergoing cesarean section under spinal anesthesia
Public title
The analgesic effects of Oxytocin
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
All patients referred for cesarean section
Lack of exclusion criteria
Exclusion criteria:
History of chronic pain and analgesic use, bleeding or coagulation disorder, peptic ulcer, renal or hepatic insufficiency and asthma, uterine atony, twins, placenta previa, Placental abruption, accreta placenta
Age
No age limit
Gender
Female
Phase
3
Groups that have been masked
Participant
Care provider
Outcome assessor
Data analyser
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
Patients are randomly divided into two groups by using simple random allocation method (Random number table). Numbers extracted from tables that are odd are assigned to intervention group 1 and even numbers are assigned to control group.
Blinding (investigator's opinion)
Double blinded
Blinding description
Participants and outcome assessors and analysts are unaware of the study groups
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Qazvin University of Medical Sciences
Street address
Qazvin University of Medical Sciences, Shahid Bahonar Boulevard, Qazvin
City
Qazvin
Province
Qazvin
Postal code
15315-34199
Approval date
2021-02-21, 1399/12/03
Ethics committee reference number
IR.QUMS.REC.1399.496
Health conditions studied
1
Description of health condition studied
Cesarean
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Pain after cesarean section
Timepoint
Up to 24 hours after delivery
Method of measurement
Verbal Rating Scale
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Patients referred for cesarean section. For spinal anesthesia of 0.5% bupivacaine hydrochloride (4 ml / 20 mg ampoule - Mylan made in France by Haupt Pharma Livron SAS) in the amount of 2.5 cc in the midline of the spine between 2 and 3 Or 4 and 5 lumbar vertebrae of needle number 25 will be used in a sitting position. In group B, to control bleeding after placental abruption, oxytocin is injected 20 units in normal saline at a rate of 10 cc per minute. In group B, immediately after surgery, 10 units of normal saline will be added to the prescribed serums every 8 hours (30 units in 24 hours)
Category
Treatment - Drugs
2
Description
Control group: Patients referred for cesarean section. For spinal anesthesia of 0.5% bupivacaine hydrochloride (4 ml / 20 mg ampoule - Mylan made in France by Haupt Pharma Livron SAS) in the amount of 2.5 cc in the midline of the spine between 2 and 3 Or 4 and 5 lumbar vertebrae of needle number 25 will be used in a sitting position. In group A, to control bleeding after placental abruption, oxytocin (one milliliter ampoule / 10 units - manufactured by Caspian Tamin Pharmaceutical Company) is injected 20 units in normal saline at a rate of 10 cc per minute. This group does not receive oxytocin for 24 hours after delivery.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Kosar Hospital, Qazvin
Full name of responsible person
Mohammadmahdi Mirnasseri
Street address
Taleghani Street, next to the electricity office
City
Qazvin
Province
Qazvin
Postal code
34156 13176
Phone
+98 28 3323 6374
Fax
+98 28 3323 6374
Email
mirnasseri@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Qazvin University of Medical Sciences
Full name of responsible person
Seyd Mahdi Mirhashemi
Street address
Shavid Beheshti Boulevard is a Sub-district of Maudat