Comparison of the success rate of spinal anesthesia with lidocaine and spinal anesthesia with meperidine in anal fissure surgery
Design
Clinical trial with control and control groups, double-blind, randomized, phase 3 on 138 patients
Settings and conduct
After referring to Ayatollah Kashani Hospital in Isfahan and Hazrat Ali Asghar (AS) Noro Hospital and checking the operation conditions, the samples are entered into the study and then they are randomly (by SPSS software) into two groups for anesthesia. They are divided into preoperative spinal anesthesia with lidocaine or spinal anesthesia with meperidine. This is a two-blind study in which the patient is unaware of the assigned group and also the surgeon who measures and evaluates the results of the intervention is unaware of the assigned group.
Participants/Inclusion and exclusion criteria
all of patient with chronic anal fissure
Intervention groups
group 1:anal fissure surgery with spinal anesthesia with meperidine
group2:anal fissure surgery with spinal anesthesia with lidocain
Main outcome variables
Intraoperative sphincter tone in Fisher Anal surgery: Postoperative analgesia: Effects of lidocaine and meperidine on the central nervous system and different side effects of these two drugs in patients
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20180921041078N1
Registration date:2020-12-26, 1399/10/06
Registration timing:retrospective
Last update:2020-12-26, 1399/10/06
Update count:0
Registration date
2020-12-26, 1399/10/06
Registrant information
Name
Ali Rezaee
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 31 3265 4563
Email address
ali_medi_84@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-08-24, 1397/06/02
Expected recruitment end date
2020-08-22, 1399/06/01
Actual recruitment start date
2018-08-23, 1397/06/01
Actual recruitment end date
2020-08-22, 1399/06/01
Trial completion date
2020-08-22, 1399/06/01
Scientific title
Comparison of the success rate of spinal anesthesia with lidocaine and spinal anesthesia with meperidine in anal fissure surgery.
Public title
effectiveness between lidocain and meperidin in anal fissure
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
all patients with anal fissure
Exclusion criteria:
Patient dissatisfaction with spinal anesthesia
infection site of spinal anesthesia
coagolopathy
Age
No age limit
Gender
Both
Phase
3
Groups that have been masked
Participant
Sample size
Target sample size:
120
Actual sample size reached:
138
Randomization (investigator's opinion)
Randomized
Randomization description
The anesthesiologist performs spinal anesthesia with lidocaine and pethidine as one of the patients, and the surgeon does not know how the drug is used in spinal anesthesia.
Also a surgical nurse who does not know how to operate (blind sampling)
Blinding (investigator's opinion)
Double blinded
Blinding description
lack of patients awareness
lack of surgeon awareness to plan of spinal anesthesia
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Isfahan University of Medical Sciences
Street address
Sofe ave ,Alzahra hospital,Isfahan town (General surgeon official)
City
Isfahan
Province
Isfehan
Postal code
8174675731
Approval date
2018-08-11, 1397/05/20
Ethics committee reference number
IR.MUI.RESEARCH.REC.1397.105
Health conditions studied
1
Description of health condition studied
chronic anal fissure
ICD-10 code
K60.1
ICD-10 code description
Chronic anal fissure
Primary outcomes
1
Description
sphincter tone in spinal anesthesia with meperidine compared to spinal anesthesia with lidocaine
Timepoint
During the anal fissure surgery
Method of measurement
Anal manometry
2
Description
Comparison of mean pain score in 2 hours. 4, 6, 12 and 24 after surgery based on NSR questionnaire in spinal anesthesia with lidocaine and meperidine
Timepoint
after surgery
Method of measurement
NSR questionnaire
3
Description
Comparison of the frequency distribution of lidocaine-induced complications with meperidine-induced complications during and after surgery in two methods of spinal anesthesia with lidocaine and spinal anesthesia with meperidine
Timepoint
During and after surgery
Method of measurement
NSR questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: The patient is placed in a sitting position after rinsing the back with betadine solution of 24-gauge Quinke spinal needle No. 24 (24-gauge Quinke spinal needle) enters the intrathecal space between the fourth and fifth lumbar vertebrae and after confirming the intrathecal space with fluid out The spinal cord is used from the end of a 25 mg pethidine needle. The patient remains seated for 5 minutes and then the patient is placed in a suitable position (lithotomy) to perform the relevant operation.
Category
Treatment - Drugs
2
Description
Control group: The patient is placed in a sitting position after washing the back with betadine solution of 24-gauge Quinke spinal needle No. 24 (24-gauge Quinke spinal needle) enters the intrathecal space between the fourth and fifth lumbar vertebrae and after confirming the intrathecal space with fluid exit Spinal cord From the end of the needle of lidocaine drug 0.5 ml of 5% lidocaine is used. The patient remains seated for 5 minutes and then the patient is placed in a suitable position (lithotomy) to perform the relevant operation.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Kashani Hospital
Full name of responsible person
Safaee Masome MD (SURGEON)
Street address
KASHANI AVE .KASHANI HOSPITAL. ISFAHAN
City
ISFAHAN
Province
Isfehan
Postal code
51839-83434
Phone
+98 31 3223 0091
Fax
Email
ali_medi_84@yahoo.com
Web page address
2
Recruitment center
Name of recruitment center
Khorshid Hospital
Full name of responsible person
Safaee Masome MD (SURGEON)
Street address
Ostandari Ave.Isfahan town
City
Isfahan
Province
Isfehan
Postal code
81839-83434
Phone
+98 31 3222 2127
Email
ali_medi_84@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Yosof Gheysari MD
Street address
Sofe Ave ,Isfahan univercity,Isfahan town
City
Isfahan
Province
Isfehan
Postal code
۸۱۷۴۶۷۳۴۴۱
Phone
+98 31 3793 2171
Email
research.deputy@dean.ui.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Research and Technology Official
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Ali Rezaee
Position
Resident
Latest degree
Specialist
Other areas of specialty/work
General Surgery
Street address
General surgeon official,Alzahra hospital,Isfahan town
City
Isfahan
Province
Isfehan
Postal code
8174675731
Phone
+98 31 1668 5555
Email
ali_medi_84@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Safaee Masome MD
Position
Professor
Latest degree
Specialist
Other areas of specialty/work
General Surgery
Street address
General surgeon official, Alzahra hospital,Isfahan town
City
Isfahan
Province
Isfehan
Postal code
8174675731
Phone
+98 31 1668 5555
Fax
Email
safaee.masumeh@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Ali Rezaee
Position
Resident
Latest degree
Specialist
Other areas of specialty/work
General Surgery
Street address
General surgeon official,Alzahra hospital,Isfahan town
City
Isfahan
Province
Isfehan
Postal code
8174675731
Phone
+98 31 1668 5555
Email
ali_medi_84@yahoo.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD