Comparison of the effect of adding pethidine to bupivacaine and half of ropivacaine on the severity of pain in women referred to Motahari Hospital during elective cesarean section.
Comparison of the effect of adding pethidine to half-percent bupivacaine and half-percent ropivacaine on pain intensity in women undergoing elective cesarean section
Design
This study will be a double-blind randomized clinical trial with parallel groups on 60 patients referred to Motahhari Hospital who are undergoing cesarean section. Patients participating in the study will be divided into two groups by tossing coins.
Settings and conduct
Patients referred to Motahhari Hospital in Jahrom who will undergo cesarean section will be included in the study. Patients participating in the study will be divided into two groups of bupivacaine and ropivacaine by throwing coins. The person participating in the study, the researcher and the data collector will be unaware of the type of drug used.
Participants/Inclusion and exclusion criteria
Admission requirements: All women referred to Motahhari Hospital in Jahrom who underwent cesarean section and expressed their consent to participate in the study. Non-entry conditions: includes patients who do not have hemodynamic stability and suffer from acute and chronic pain.
Intervention groups
Intervention group1: received 12/5 mg bupivacaine + 10 mg pethidine intrathecally. Intervention group 2: receive 15 mg of ropivacaine + 10 mg of pethidine intrathecally.
Main outcome variables
Pain
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20210415050976N10
Registration date:2022-02-19, 1400/11/30
Registration timing:registered_while_recruiting
Last update:2022-02-19, 1400/11/30
Update count:0
Registration date
2022-02-19, 1400/11/30
Registrant information
Name
navid kalani
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 71 5433 6085
Email address
k.navid@juma.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-11-01, 1400/08/10
Expected recruitment end date
2022-08-01, 1401/05/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the effect of adding pethidine to bupivacaine and half of ropivacaine on the severity of pain in women referred to Motahari Hospital during elective cesarean section.
Public title
Comparison of the effect of adding pethidine to half-percent bupivacaine and half-percent ropivacaine on pain intensity in women undergoing elective cesarean section
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Hemodynamic stability
Not having infection at the site of needle entry
Not having High intracranial pressure
Not having coagulation disorders
Exclusion criteria:
History of addiction
Allergy to drugs
Obesity
Age
From 17 years old to 45 years old
Gender
Female
Phase
3
Groups that have been masked
Participant
Investigator
Outcome assessor
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
In this study, block randomization method is used. With the help of the online site (www.sealedenvelope.com/simple-randomiser/v1/lists) randomization, 2 blocks of 30 are created. In each randomly assigned block, 30 patients are assigned to the bupivacaine group and 30 patients to the bupivacaine group.
Blinding (investigator's opinion)
Double blinded
Blinding description
For blinding in the present study, the double-blind method is used, so that 1- the person who examines the results and 2- the person who performs the
injections do not know which patient received ropivacaine or bupivacaine.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Jahrom University of Medical Sciences
Street address
Jahrom, Shahid Motahari Boulevard, Jahrom University of Medical Sciences, Vice Chancellor for Research
City
Jahrom
Province
Fars
Postal code
7167758256
Approval date
2020-09-02, 1399/06/12
Ethics committee reference number
IR.JUMS.REC.1399.074
Health conditions studied
1
Description of health condition studied
Cesarean section
ICD-10 code
O75.82
ICD-10 code description
Onset (spontaneous) of labor after 37 completed weeks of gestation but before 39 completed weeks gestation, with delivery by (planned) cesarean section
Primary outcomes
1
Description
Pain
Timepoint
When entering the operating room, when entering the recovery, leaving the recovery, 2 hours after the operation, 6 hours after the operation, 12 hours after the operation and 24 hours after the operation
Method of measurement
Visual scale of pain
Secondary outcomes
1
Description
Blood pressure changes
Timepoint
Before the operation, before the spinal, immediately after the spinal, after the baby is born and then every 10 minutes until the end of the operation, when entering the recovery, when leaving the recovery)
Method of measurement
monitoring
2
Description
Heart Rate
Timepoint
Before the operation, before the spinal, immediately after the spinal, after the baby is born and then every 10 minutes until the end of the operation, when entering the recovery, when leaving the recovery)
Method of measurement
monitoring
Intervention groups
1
Description
Intervention group: 12/5mg of bupivacaine as a local anesthetic made by Abu Reihan Pharmaceutical Company + 10 mg of pethidine as a narcotic made by Elixir Pharmaceutical Company Received intrathecally.
Category
Treatment - Drugs
2
Description
Intervention group 1: 15 mg of ropivacaine as a local anesthetic made by Abu Reihan Pharmaceutical Company + 10 mg of pethidine as a narcotic made by Elixir Pharmaceutical Company Received intrathecally.