To evaluate the efficacy of electroacupuncture on urinary retention after spinal anesthesia
Design
Randomized, double blind clinical trial with two arm parallel groups
Settings and conduct
In a general University hospital candidates of lower extremity or anorectal surgeryunder spinal anesthesia will be enrolled. After surgery when the level of spinal anesthesia reaches the T10 the intervention group receives electroacupuncture for 10 minutes. In the placebo group the leads are attached to the patients without stimulation.
The patients are blinded to the assignments regarding the analgesia after spinal anesthesia. The investigator is also blinded to the allocations.
Participants/Inclusion and exclusion criteria
Candidates of lower extremity or anorectal surgery under spinal anesthesia will be enrolled. Those with history of urinary problems, need for intraoperative catheterization or unavailability of needling sites (SP6, SP9, ST28, Ren2) would not be recruited. In the case of need for changing the method of anesthesia, urinary trauma or catheterization patients will be excluded.
Intervention groups
After surgery when the level of spinal anesthesia reaches the T10 the intervention group receives electroacupuncture at SP6, SP9, ST28, Ren2 points for 10 minutes. In the placebo group the leads are attached to the patients without stimulation.
Main outcome variables
Time to first urination from spinal anesthesia,
Time to first urination from the intervention, complain of difficult urination,
need for catheterization due to urinary retention
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20101026005026N10
Registration date:2019-06-30, 1398/04/09
Registration timing:registered_while_recruiting
Last update:2019-06-30, 1398/04/09
Update count:0
Registration date
2019-06-30, 1398/04/09
Registrant information
Name
Masood Mohseni
Name of organization / entity
Rasul Akram hospital, Tehran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 6435 2326
Email address
mohseni@med.mui.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-01-31, 1397/11/11
Expected recruitment end date
2020-01-31, 1398/11/11
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Efficacy of electroacupuncture on urinary retention after spinal anesthesia
Public title
Efficacy of electroacupuncture on urinary retention after spinal anesthesia
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Candidates of lower extremity or anorectal surgery under spinal anesthesia
Exclusion criteria:
history of urinary problems
need for intraoperative urinary catheterization
No access to acupuncture points
Age
From 18 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Investigator
Outcome assessor
Sample size
Target sample size:
114
Randomization (investigator's opinion)
Randomized
Randomization description
simple randomization using table of random numbers
Blinding (investigator's opinion)
Double blinded
Blinding description
Patients do not sense the needling because of spinal anesthesia. A separating curtain also limits the sight of patients. The investigator who evaluates the outcomes is blinded to the interventions.
Placebo
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
Hemmat Highway, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
۱۴۴۵۶۱۳۱۳۱
Approval date
2018-01-28, 1396/11/08
Ethics committee reference number
IR.IUMS.REC.1398.035
Health conditions studied
1
Description of health condition studied
urinary retention after spinal anesthesia
ICD-10 code
N99.8
ICD-10 code description
Other intraoperative and postprocedural complications and disorders of genitourinary system
Primary outcomes
1
Description
The rate of urinary catheterization after surgery under spinal anesthesia
Timepoint
from early recovery up to 6 hours after surgery
Method of measurement
direct observation
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Surface Electroacupuncture for 10 minutes at ST28, Ren2, SP6 & SP9 acupoints
Category
Treatment - Other
2
Description
Control group: Surface electroacupuncture without stimulation at ST28, Ren2, SP6 & SP9 acupoints
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Rasoul Akram hospital
Full name of responsible person
Masood Mohseni
Street address
Niayesh Ave., Sattar Khan St
City
Tehran
Province
Tehran
Postal code
1458843337
Phone
+98 21 6435 2326
Email
Mohseni.ma@iums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Kazem Malakouti
Street address
Niayesh Ave., Sattarkhan St.
City
Tehran
Province
Tehran
Postal code
1458843337
Phone
+98 21 6435 2326
Email
Mohseni.ma@iums.ac.ir
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
Masood Mohseni
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Niayesh Ave., Sattar Khan St
City
Tehran
Province
Tehran
Postal code
1458843337
Phone
+98 21 6435 2326
Email
Mohseni.ma@iums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Masood Mohseni
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Niayesh Ave., Sattar Khan St
City
Tehran
Province
Tehran
Postal code
1458843337
Phone
+98 21 6435 2326
Email
Mohseni.ma@iums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Mina Olia
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Anesthesiology
Street address
Niayesh Ave., Sattarkhan St.
City
Tehran
Province
Tehran
Postal code
1458843337
Phone
+98 21 6435 2326
Email
minaolia1367@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Not applicable
Data Dictionary
Not applicable
Title and more details about the data/document
IPD collected for the primary and secondary outcomes
When the data will become available and for how long
Immediately after publication
To whom data/document is available
people working in academic institutions
Under which criteria data/document could be used
The result of further analysis may not be presented to public without permission
From where data/document is obtainable
Mohseni.ma@iums.ac.ir
What processes are involved for a request to access data/document
A reasonable request from an academic source will be responded within 10 working days