Determining the effect of lidocaine injection at the subcutaneous point under the occipital ridge in acupuncture after abdominal surgery.
Design
Operating room of Bo Ali Hospital
1 cc of cutting water at the point
Subcutaneous FU
In the second group, 1 cc per point
Subcutaneous FU
is injected
Settings and conduct
Operating room of Bo Ali Hospital
1 cc of cutting water at the point
Subcutaneous FU
In the second group, 1 cc per point
Subcutaneous FU
is injected
In a blinded intervention study, only the patients are not aware of which group they are in.
Participants/Inclusion and exclusion criteria
Inclusion criteria:
Patients with ASA status one or two
Age 20 to 65 years
Elective abdominal surgery
No addiction to drugs and alcohol
Surgery duration 4 hours
Informed consent of the patient
Exclusion criteria:
Abnormal bleeding
Unusual complications during surgery
Cardiac and respiratory arrest during abdominal surgery
medical allergy
Intervention groups
two groups
Control group 1 cc of distilled water at the point
subcutaneous
intervention group, 1 cc of lidocaine in the point
FU subcutaneous
Main outcome variables
Improvement after abdominal surgery, clinical improvement, length of hospitalization
General information
Reason for update
Acronym
ندراد
IRCT registration information
IRCT registration number:IRCT20240525061885N1
Registration date:2024-06-13, 1403/03/24
Registration timing:prospective
Last update:2024-06-13, 1403/03/24
Update count:0
Registration date
2024-06-13, 1403/03/24
Registrant information
Name
Shayesteh Laali
Name of organization / entity
Tehran Islamic Azad University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 990 257 9833
Email address
shayestehlaali@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-07-06, 1403/04/16
Expected recruitment end date
2024-08-06, 1403/05/16
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of lidocaine injection at FU's subcutaneous needling point on pain after abdominal surgery
Public title
Examining the effect of lidocaine in abdominal surgery
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Patients with ASA status one or two
Age 20 to 65 years
Elective abdominal surgery
No addiction to drugs and alcohol
Surgery duration 4 hours
Informed consent of the patient
Exclusion criteria:
Abnormal bleeding
Unusual complications during surgery
Cardiac and respiratory arrest during abdominal surgery
medical allergy
Age
From 20 years old to 65 years old
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
48
More than 1 sample in each individual
Number of samples in each individual:
24
2 groups, the first group was injected with lidocaine, the second group was injected with distilled water
Randomization (investigator's opinion)
Not randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Tehran Azad University of Medical Sciences
Street address
Zargande, Imamzadeh alley, Danesh alley, Tehran Azad University of Medical Sciences
City
Tehran
Province
Tehran
Postal code
1936893813
Approval date
2024-05-20, 1403/02/31
Ethics committee reference number
IR.IAU.TMU.REC.1403.090
Health conditions studied
1
Description of health condition studied
Pain after surgery
ICD-10 code
R10
ICD-10 code description
Abdominal and pelvic pain
Primary outcomes
1
Description
Improvement after abdominal surgeryhospitalization
Timepoint
at 6, 12 and 24 hours after the operation
Method of measurement
Using a visual analog scale ( VAS)
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: 1 cc of 2% lidocaine (lidocaine hydrochloride 100 mg) is injected subcutaneously at the FU point.
Category
Prevention
2
Description
Control group: 1 cc of distilled water is injected subcutaneously at the FU point
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Bo Ali Hospital, Tehran
Full name of responsible person
Gelare Shahabpour
Street address
tehran no 3 metri emameat street zare bo bast rabee
City
tehran
Province
Tehran
Postal code
1741714473
Phone
+98 21 3355 9872
Email
m.ghasemitizabi35@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Islamic Azad University
Full name of responsible person
Gelare Shahabpur
Street address
Tehran Azad University of Medical Sciences
City
tehran
Province
Tehran
Postal code
1936893813
Phone
+98 21 2260 0037
Email
Int.affairs@tms.iau.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Islamic Azad University
Proportion provided by this source
100
Public or private sector
Private
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
Islamic Azad University
Full name of responsible person
Gelare Shahabpur
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Biostatistics
Street address
Address of the headquarters building: Tehran, Dr. Shariati St., Do Rahi Qolhak, Amir Pabarja St., Aine Blvd., corner of Gol Yakh St., Tehran Islamic Azad University of Medical Sciences headquarters building. The interior of the headquarters building - The interior of the Faculty of Medicine - The interior of the Faculty of Paramedicine - The interior of the Faculty of Medicinal Chemistry - The interior of the Faculty of Modern Sciences - The interior of the Faculty of Dentistry
City
Tehran
Province
Tehran
Postal code
1949635881
Phone
+98 21 2660 2642
Email
GelareShahabpur@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Gelare Shahabpour
Position
Consultant, Professor
Latest degree
Ph.D.
Other areas of specialty/work
Biostatistics
Street address
Address of the headquarters building: Tehran, Dr. Shariati St., Dorahi Qolhak, Amir Pabarja St., Ayane Blvd., corner of Gol Yakh St., Tehran Islamic Azad University of Medical Sciences headquarters building. Interior Headquarters - Interior of the Faculty of Medicine - Interior of the Faculty of Paramedicine - Interior of the Faculty of Medicinal Chemistry - Interior of the Faculty of Modern Sciences - Interior of the Faculty of Dentistry
City
Tehran
Province
Tehran
Postal code
1949635881
Phone
+98 21 2445 6871
Email
GelareShahabpour@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Gelare Shahabpour
Position
Consultant, Professor
Latest degree
Ph.D.
Other areas of specialty/work
Biostatistics
Street address
Address of the headquarters building: Tehran, Dr. Shariati St., Dorahi Qolhak, Amir Pabarja St., Ayane Blvd., corner of Gol Yakh St., Tehran Islamic Azad University of Medical Sciences headquarters building. Interior Headquarters - Interior of the Faculty of Medicine - Interior of the Faculty of Paramedicine - Interior of the Faculty of Medicinal Chemistry - Interior of the Faculty of Modern Sciences - Interior of the Faculty of Dentistry
City
Tehran
Province
Tehran
Postal code
1949635881
Phone
+98 21 2233 6587
Email
GelareShahabpour@gmail.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