Comparison of the efficacy of ropivacaine and bupivacaine in bioshospinal surgery for kidney stone removal surgery
Design
This study will be performed by randomized double-blind clinical trial with factorial groups on 100 patients referred to Peymaniyeh Hospital in Jahrom who are undergoing pcnl surgery. Patients participating in the study will be divided into two groups by coin toss.
Settings and conduct
Patients referred to Jahrom's Peymaniyeh Hospital, who will undergo pcnl surgery, will enter the study. Patients participating in the study will be divided into two groups, Bupivacaine and Rupivacaine, by coin toss. The study participant, the researcher, and the data collector will be unaware of the type of medication being taken.
Participants/Inclusion and exclusion criteria
All patients referred to Peymaniyeh Hospital in Jahrom who have undergone PCNL surgery and are satisfied to participate in the study and do not have the criteria to leave the study.
Intervention groups
Intervention group1: 15 mg of bupivacaine is administered intrathecally.
Intervention group2: 15 mg of ropivacaine is administered intrathecally.
Main outcome variables
Pain, movement, hemodynamics, nausea and vomiting
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20130926014779N5
Registration date:2020-06-13, 1399/03/24
Registration timing:registered_while_recruiting
Last update:2020-06-13, 1399/03/24
Update count:0
Registration date
2020-06-13, 1399/03/24
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
2020-09-26, 1399/07/05
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison efficacy of Ropivacaine versus Bupivacaine in Spinal Anesthesia in Percutaneous Nephrolithotomy
Public title
Comparison efficacy of Ropivacaine versus Bupivacaine in Spinal Anesthesia in Percutaneous Nephrolithotomy
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Hemodynamic stability
Having the desired ASA (Classes 1 and 2 were considered the criteria for entering the study)
Exclusion criteria:
People who need medication or action other than routine care during surgery to relieve complications and reduce pain.
Chronic and cancerous pains
Concomitant Disorders
High intracranial pressure
Age
From 18 years old to 70 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Care provider
Investigator
Outcome assessor
Sample size
Target sample size:
100
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, a double-blind method is used in a way that (1) the person who will review the results and (2) the person who performs the injections are unaware of which patients have received dexmedetomidine ،fentanil and bupivacaine alone
Placebo
Not used
Assignment
Factorial
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethic Committee of Jahrom University of Medical Sciences
Street address
School of medicine, Motahhari Blvd, Jahrom
City
Jahrom
Province
Fars
Postal code
716775243
Approval date
2019-11-08, 1398/08/17
Ethics committee reference number
IR.JUMS.REC.1398.043
Health conditions studied
1
Description of health condition studied
kidney stone
ICD-10 code
ICD-10 code description
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
Visual Analogue Scale
2
Description
nausea Vomiting
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
questionnaire
3
Description
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
Timepoint
bromage scale
Method of measurement
bromage scale
Secondary outcomes
1
Description
Hemodynamics
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
Monitoring device
Intervention groups
1
Description
Intervention group1: 15 mg of bupivacaine is administered intrathecally.
Category
Treatment - Drugs
2
Description
Intervention group2: 15 mg of ropivacaine is administered intrathecally.