1. Home
  2. Approved trials
  3. » فارسی

study the effects and complications of bilateral spinal anesthsia with the unilateral spinal anesthesia in patients suffering unilateral inguinal hernia

Protocol summary

Study aim
Study the effects and complications of bilateral spinal anesthsia with the unilateral spinal anesthesia in patients suffering unilateral inguinal hernia
Design
A clinical trial without control group, with parallel, unblinded, randomized groups
Settings and conduct
A peripheral vein No. 18 is inserted per patient and 10 cc/kg of Ringer patient weight is injected. Then, according to the randomization table, each patient enters group B (bilateral spinal anesthesia) or group U (unilateral spinal anesthesia). In group B, patients were placed in a sitting position, after complete sterilization, with a Quincke 25G needle pierced through the L4-L5 intervertebral space after transcutaneous cerebrospinal fluid flow, 2.5 cc of bupivacaine. 0.5% isobar is injected at 1 cc for 30 seconds and is restored to the supine position immediately after the injection is completed. In group U, patients were placed supine, with the lower hernia positioned, after complete sterilization, with the Quincke 25G needle pierced through the L4-L5 intervertebral needle after clear fluid flow. The spinal cord, 1.5 cc of 0.5% isobar bupivacaine, is injected at 1 cc for 30 seconds, remaining in the same position for 15 minutes and then resting on the supine position.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Patients with a unilateral inguinal hernia; Patients with grade 1 and two ASA; Exclusion criteria: Patient dissatisfaction with spinal anesthesia; Coagulopathy; Sensitivity to topical anesthetics; Cerebrospinal cord injury; An ulcer or infection in the area of anesthesia; Lack of proper anesthesia for any reason
Intervention groups
We have two intervention groups. The first group has bilateral spinal anesthesia and the second group has unilateral spinal anesthesia.
Main outcome variables
Blood pressure, heart rate, oxygen saturation

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20171030037093N19
Registration date: 2019-09-30, 1398/07/08
Registration timing: prospective

Last update: 2019-09-30, 1398/07/08
Update count: 0
Registration date
2019-09-30, 1398/07/08
Registrant information
Name
Sadra Ansaripour
Name of organization / entity
Shahrekord University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 31 3650 3487
Email address
st_ansari.s@skums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-10-23, 1398/08/01
Expected recruitment end date
2020-04-20, 1399/02/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
study the effects and complications of bilateral spinal anesthsia with the unilateral spinal anesthesia in patients suffering unilateral inguinal hernia
Public title
study the effects and complications of bilateral spinal anesthsia with the unilateral spinal anesthesia in patients suffering unilateral inguinal hernia
Purpose
Diagnostic
Inclusion/Exclusion criteria
Inclusion criteria:
Patients with unilateral inguinal hernia Patients with grade 1 and two ASA
Exclusion criteria:
Patient dissatisfaction with spinal anesthesia Coagulopathy Sensitivity to topical anesthetics Cerebrospinal cord injury An ulcer or infection in the area of anesthesia Lack of proper anesthesia for any reason
Age
From 18 years old to 70 years old
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size: 100
Randomization (investigator's opinion)
Randomized
Randomization description
The study sample was randomly divided into two groups of 50 people, each by selective envelopes. Thus, each envelope containing one of the three U and B labels represented one of the groups.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Hormozgan University of Medical Sciences
Street address
Deputy of research and technology, the Supreme Prophet's Hospital, Bandar Abbas
City
Bandar Abbas
Province
Hormozgan
Postal code
9791991551
Approval date
2018-05-13, 1397/02/23
Ethics committee reference number
IR.HUMS.REC.1397.037

Health conditions studied

1

Description of health condition studied
unilateral inguinal hernia
ICD-10 code
K40.4
ICD-10 code description
Unilateral inguinal hernia, with gangrene

Primary outcomes

1

Description
Blood pressure
Timepoint
Before anesthesia and immediately after injection of anesthesia and after 5, 10 and 15 minutes
Method of measurement
measurement

2

Description
heart rate
Timepoint
Before anesthesia and immediately after injection of anesthesia and after 5, 10 and 15 minutes
Method of measurement
measurement

3

Description
oxygen saturation
Timepoint
Before anesthesia and immediately after injection of anesthesia and after 5, 10 and 15 minutes
Method of measurement
measurement

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: In this group, bilateral spinal anesthesia is performed and the patients are in a sitting position, after complete sterilization, with the Quincke 25G needle pierced through the L4-L5 intervertebral space after clear flow. The cerebrospinal fluid, 2.5 cc of 0.5% isobar bupivacaine, is injected at 1 cc for 30 seconds and is restored to the supine position immediately after completion of the injection.
Category
Treatment - Drugs

2

Description
Intervention group: In this group, unilateral spinal anesthesia is performed. Patients were placed in a supine position with the lower hernia positioned, after complete sterilization, with the Quincke 25G needle pierced through the L4-L5 intervertebral space after a clear flow of cerebrospinal fluid, 1.5 cc of 0.5% isobar bupivacaine is injected at 1 cc for 30 seconds and remains in the same position for 15 minutes after completion of the patient's injection and then rests on the supine position.
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Shahid Mohammadi Hospital of Bandar Abbas
Full name of responsible person
Hashem Jarineshin
Street address
Boulevard of the Islamic Republic of Iran, Bandar Abbas, Shahid Mohammadi Hospital
City
Bandar Abbas
Province
Hormozgan
Postal code
9791991551
Phone
+98 76 3334 7000
Email
Anrc.hums@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Bandare-abbas University of Medical Sciences
Full name of responsible person
Abdul Azim Nejati Zadeh
Street address
Deputy of research and technology, East Side, Bandar Abbas Hospital, Bandar Abbas
City
Bandar Abbas
Province
Hormozgan
Postal code
9791991551
Phone
+98 71 3333 5794
Email
azimnejate @yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Bandare-abbas University of Medical Sciences
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
Iran University of Medical Sciences
Full name of responsible person
Hashem Jarineshin
Position
Associate Professor of Anesthesiology
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Department of Anesthesiology, Shahid Mohammadi Hospital
City
Bandar Abbas
Province
Hormozgan
Postal code
9791991551
Phone
+98 917 361 3464
Email
shmh@hums.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Hashem Jarineshin
Position
Associate Professor of Anesthesiology
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Department of Anesthesiology, Shahid Mohammadi Hospital
City
Bandar Abbas
Province
Hormozgan
Postal code
9791991551
Phone
+98 917 361 3464
Email
shmh@hums.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Hashem Jarineshin
Position
Associate Professor of Anesthesiology
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Department of Anesthesiology, Shahid Mohammadi Hospital
City
Bandar Abbas
Province
Hormozgan
Postal code
9791991551
Phone
+98 917 361 3464
Email
shmh@hums.ac.ir

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
No - There is not a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
Information about the main outcome can be shared.
When the data will become available and for how long
Start the access period 4 months after publishing the results
To whom data/document is available
Researchers working in academia
Under which criteria data/document could be used
Use data to complete clinical trial studies
From where data/document is obtainable
Shahid Mohammadi Hospital
What processes are involved for a request to access data/document
After the investigation of the researcher request and presentation of required documents will be accessible.
Comments
Loading...