Comparison of the effect of adding sufentanil to rupivacaine 0.5% and sufentanil to bupivacaine 0.5% on analgesia and chills during and after surgery in subjects undergoing elective cesarean section
Comparison of the effect of adding sufentanil to rupivacaine 0.5% and sufentanil to bupivacaine 0.5% on analgesia and chills during and after surgery in subjects undergoing elective cesarean section
Design
This study will be a double-blind randomized clinical trial with factorial groups on 60 patients referred to Motahhari Hospital in Jahrom 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 study participant, researcher, and data collector will be unaware of the type of drug used.
Participants/Inclusion and exclusion criteria
All patients referred to Motahhari Hospital in Jahrom who underwent cesarean section and expressed their consent to participate in the study and did not meet the exclusion criteria.
Intervention groups
The intervention group 1: received 15 mg of bupivacaine and sufentanil intrathecally. Intervention group 2: received 15 mg of rupivacaine and sufentanil intrathecally.
Main outcome variables
Pain, chills
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20130926014779N7
Registration date:2020-08-29, 1399/06/08
Registration timing:registered_while_recruiting
Last update:2020-08-29, 1399/06/08
Update count:0
Registration date
2020-08-29, 1399/06/08
Registrant information
Name
Navid Kalani
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 71 5426 4192
Email address
k.navid@jums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-12-31, 1398/10/10
Expected recruitment end date
2020-11-30, 1399/09/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the effect of adding sufentanil to rupivacaine 0.5% and sufentanil to bupivacaine 0.5% on analgesia and chills during and after surgery in subjects undergoing elective cesarean section
Public title
The effect of adding sufentanil to rupivacaine 0.5% and sufentanil to bupivacaine 0.5% on analgesia and chills during and after surgery in subjects undergoing elective cesarean section
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Interest in participating in the study
No chronic pain and cancer
No hearing or verbal impairment
Hemodynamic stability
No infection at the site of needle entry
Not High intracranial pressure
No coagulation disorders
Exclusion criteria:
People who need medication or action other than routine care during surgery to relieve complications and reduce pain.
Age
From 16 years old to 45 years old
Gender
Female
Phase
1-2
Groups that have been masked
Participant
Care provider
Investigator
Outcome assessor
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
Patients participating in the present study were divided into two groups by coin toss.
Blinding (investigator's opinion)
Double blinded
Blinding description
For blinding in the present study, the double-blind method is used in such a way that 1- the person who participates in the study 2- the person who reviews the results and 3- the person who performs the injections information are unaware of which patients have received rupivacaine and which patients have received sufentanil and 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
School of Medicine, Motahhari Blvd., Jahrom
City
Jahrom
Province
Fars
Postal code
716775522
Approval date
2020-02-17, 1398/11/28
Ethics committee reference number
IR.JUMS.REC.1398.110
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
Before the spinal, after the spinal and during the change of position of the patient and then every 15 minutes to the first hour and also during the entry into recovery and when leaving the recovery and finally three and six hours after the operation
Method of measurement
Pain assessment ruler
2
Description
Shivering
Timepoint
Before the spinal, after the spinal and during the change of position of the patient and then every 15 minutes to the first hour and also during the entry into recovery and when leaving the recovery and finally three and six hours after the operation