Comparison of relative frequency of post-operative urinary retention in two methods of spinal analgesia with and without opioid
Design
This study is a Single-blind randomized clinical trial in which the number of patients is determined according to the sample size formula and using a simple randomization method, which uses a random number table for each patient. The code is given and patients are randomly assigned to two treatment groups, with random code selection.
Settings and conduct
To perform spinal anesthesia in both groups, the patient is sitting or lying on his side. We explain the procedure to the patient and ask the patient to work with the anesthesia nurse by taking the knees and giving the abdomen inwards and sticking the chin to the chest.By observing these points by the patient, the injection site is better observed and identified. The skin is then sterilized with a gas and betadine and sterilized with white alcohol. The specialist then inserts the spinal needle into the designated space and injects the drug into that area. However, before injecting the drug, it is first pulled out of the liquid to ensure the correct location of the needle.The study will be conducted at Firoozgar and Rasoul Akram Hospitals.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Patients are candidates for lower limb orthopedic surgery Patients are candidates for anorectal surgery Exclusion criteria: Patients with a history of urinary problems, Patients with a history of diabetes, Pregnant women
Intervention groups
Frist groop: Patients candidates for lower limb Orthopedic surgery or Anorectal surgery under spinal anesthesia with Opioid. Second group: Patients candidates for lower limb Orthopedic surgery or Anorectal surgery under spinal anesthesia without Opioid.
Main outcome variables
Urinary retention, complaining of incomplete urination
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20200525047563N1
Registration date:2020-05-28, 1399/03/08
Registration timing:registered_while_recruiting
Last update:2020-05-28, 1399/03/08
Update count:0
Registration date
2020-05-28, 1399/03/08
Registrant information
Name
Azadeh Emami
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 2237 0673
Email address
azademami@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-05-20, 1399/02/31
Expected recruitment end date
2020-10-20, 1399/07/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of relative frequency of post-operative urinary retention in two methods of spinal analgesia with and without opioid.
Public title
Comparison of relative frequency of post-operative urinary retention in two methods of spinal analgesia with and without opioid.
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients are candidates for lower limb orthopedic surgery
Patients are candidates for anorectal surgery
Exclusion criteria:
Patients with a history of urinary problems
Patients with a history of diabetes
Pregnant women
Age
No age limit
Gender
Both
Phase
3
Groups that have been masked
Data analyser
Sample size
Target sample size:
80
Randomization (investigator's opinion)
Randomized
Randomization description
For randomization, a simple randomization method is used, which is done using a table of random numbers.To use the number of random numbers, we first determine the reading path of the table numbers (for example, top, bottom, left or right).Then we assume certain numbers for each group (for example, even numbers for intervention A and odd numbers for intervention B).Then we touch on one of the numbers and move in one of the predetermined directions and record the numbers and assign them to different groups.
Blinding (investigator's opinion)
Single blinded
Blinding description
In this study, a person who is responsible for analyzing statistical data is not aware of the treatment process and study groups and the information is provided to that person in groups A and B. This helps the person's personal opinion not to affect the results
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Iran University of Medical Sciences
Street address
Iran University of Medical Sciences., Hemmat Highway., Next to Milad Tower., Tehran Town
City
Tehran
Province
Tehran
Postal code
1433933111
Approval date
2020-05-18, 1399/02/29
Ethics committee reference number
IR.IUMS.FMD.REC.1399.136
Health conditions studied
1
Description of health condition studied
Lower limb Orthopedic surgery
ICD-10 code
Y79.3
ICD-10 code description
Surgical instruments, materials and orthopedic devices (including sutures) associated with adverse incidents
Primary outcomes
1
Description
Urinary retention
Timepoint
after surgery
Method of measurement
Ask the patient
Secondary outcomes
1
Description
Complaints of incomplete urination
Timepoint
After surgery
Method of measurement
Ask the patient
Intervention groups
1
Description
Intervention group:To perform spinal anesthesia in the first group, first fluid therapy with normal saline injection serum up to 300 cc is performed. Then the patient is placed sitting or lying on his side. We explain the procedure to the patient and ask the patient to work with the anesthesia nurse by taking the knees and giving the abdomen inwards and sticking the chin to the chest. By observing these points by the patient, the injection site is better observed and identified. The skin is then sterilized with a gas and betadine and sterilized with white alcohol. Then, the specialist doctor inserts a spinal needle of the appropriate size in the designated space and injects 1.5-2 cc of marcaine (0.05%, produced by Cobel Darou) in addition to 25 micrograms of fentanyl. However, before injecting the drug, it is first pulled out of the liquid to ensure the correct location of the needle.
Category
Treatment - Drugs
2
Description
To perform spinal anesthesia in the second group, first fluid therapy with normal saline injection serum up to 300 cc is performed. Then the patient is sitting or lying on his side. We explain the procedure to the patient and ask the patient to work with the anesthesia nurse by taking the knees and giving the abdomen inwards and sticking the chin to the chest. By observing these points by the patient, the injection site is better observed and identified. The skin is then sterilized with a gas and betadine and sterilized with white alcohol. Then the specialist doctor enters the spinal needle with the appropriate size in the prescribed space and injects 2.5-2 cc of marcaine (0.05% produced by Cobel Darou) in that place. However, before injecting the drug, it is first pulled out of the liquid a little to ensure the correct entry of the needle.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Firoozgar Hospital
Full name of responsible person
Azadeh Emami
Street address
Iran University of Medical Sciences., Hemmat Highway., Next to Milad Tower., Tehran Town
City
Tehran
Province
Tehran
Postal code
1433933111
Phone
+98 21 2237 0673
Email
azi_emami@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Seyed Abbas Motavalian
Street address
Iran University of Medical Sciences., Hemmat Highway., Next to Milad Tower., Tehran Town
City
Tehran
Province
Tehran
Postal code
1433933111
Phone
+98 21 2237 0673
Email
azi_emami@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Iran 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
Azadeh Emami
Position
Assistant professor
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Iran University of Medical Sciences., Hemmat Highway., Next to Milad Tower., Tehran Town
City
Tehran
Province
Tehran
Postal code
1433933111
Phone
+98 21 2237 0673
Email
azi_emami@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Azadeh Emami
Position
Assistant professor
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Iran University of Medical Sciences., Hemmat Highway., Next to Milad Tower., Tehran Town
City
Tehran
Province
Tehran
Postal code
1433933111
Phone
+98 21 2237 0673
Email
azi_emami@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Azadeh Emami
Position
Assistant professor
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Iran University of Medical Sciences., Hemmat Highway., Next to Milad Tower., Tehran Town
City
Tehran
Province
Tehran
Postal code
1433933111
Phone
+98 21 2237 0673
Email
azi_emami@yahoo.com
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
Undecided - It is not yet known if there will be 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
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available