Comparison of block quality and complications after spinal anesthesia using two different doses marcaine and fentanyl in leg fracture surgery in opium abusers
Comparison of block quality and complications after spinal anesthesia using different doses of marcaine and fentanyl in leg fracture surgery in drug addicts
Design
The sampling method will be simple random so that 80 cards with two different colors, each color will represent a group, will be placed in a box. After entering the operating room, the patient will first check the entry criteria and if he has Being the entry criterion, a card will be pulled out of the box and will be placed in the desired group (B or A) according to the color of the card.
Settings and conduct
After obtaining informed consent, it will be performed in the operating room of Imam Reza (AS) Hospital in Birjand.
Participants/Inclusion and exclusion criteria
Admission requirements: patients candidate for leg fracture surgery (Non-Emergency); age between 15-65 years old ASA (American Anesthesia Society class) addiction (1,2) who is a candidate for elective fracture leg surgery and contraindicated spinal anesthesia (dissatisfaction, high ICP, skin infection in the area of anesthesia) If not, they will enter the study.
Withdrawal conditions: patients with coagulation problems; no addiction; emergency surgery; duration of surgery lasting more than two hours; change in anesthesia during surgery; uncontrolled comorbid disease (ASA3 and above); history of postoperative bleeding coagulation or infectious heart disease; known allergy to amide anesthetics; use of psychotropic drugs.
Intervention groups
Evaluation is performed to compare the effects of fentanyl and marcaine on spinal anesthesia in addicted patients undergoing orthopedic fracture surgery. Sampling in this study is done by non-probability sampling method of available type.
Main outcome variables
Type of anesthetic; duration of analgesia; pain; nausea; vomit; need housing; itching
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20210218050400N2
Registration date:2021-03-16, 1399/12/26
Registration timing:registered_while_recruiting
Last update:2021-03-16, 1399/12/26
Update count:0
Registration date
2021-03-16, 1399/12/26
Registrant information
Name
habibe momeni
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 56 3290 4004
Email address
habibe.momeni@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-02-27, 1399/12/09
Expected recruitment end date
2021-11-30, 1400/09/09
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of block quality and complications after spinal anesthesia using two different doses marcaine and fentanyl in leg fracture surgery in opium abusers
Public title
Comparison of block quality and complications after spinal anesthesia using two different doses marcaine and fentanyl in leg fracture surgery in opium abusers
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients who are candidates for leg fracture surgery (non-emergency) referred to Imam Reza (AS) Hospital in Birjand
Exclusion criteria:
Patients with coagulation problems
Addiction
Emergency surgery
Duration of surgery lasting more than two hours
Change in anesthesia during surgery
Uncontrolled comorbid disease (ASA3 and above)
History of postoperative bleeding
Coagulation heart disease or infectious
Known allergy to amide anesthetics
Use of psychotropic drugs
Age
From 15 years old to 65 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Care provider
Sample size
Target sample size:
80
Randomization (investigator's opinion)
Randomized
Randomization description
Double-blind randomized controlled clinical trial
Blinding (investigator's opinion)
Double blinded
Blinding description
The participant and the clinician do not know which syringe to inject.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Birjand University of Medical Sciences
Street address
Ghafari St.
City
Birjand
Province
South Khorasan
Postal code
9777139682
Approval date
2020-07-13, 1399/04/23
Ethics committee reference number
IR.BUMS.REC.1399.167
Health conditions studied
1
Description of health condition studied
Fracture
ICD-10 code
T12
ICD-10 code description
Fracture of lower limb, level unspecified
Primary outcomes
1
Description
Pain
Timepoint
1-2-3-4-8-12 hours after the measurement operation
Method of measurement
VAS
2
Description
Nausea
Timepoint
1-2-3-4-8-12 hours after the measurement operation
Method of measurement
The patient is asked if he or she feels overwhelmed or upset.
3
Description
Vomiting
Timepoint
1-2-3-4-8-12 hours after the measurement operation
Method of measurement
The patient is asked
4
Description
Itching
Timepoint
1-2-3-4-8-12 hours after the measurement operation
Method of measurement
The patient is asked
5
Description
Need for pain killers
Timepoint
1-2-3-4-8-12 hours after the measurement operation
Method of measurement
Based on the onset of pain and the patient's first request for analgesia
Secondary outcomes
empty
Intervention groups
1
Description
Control group:All patients undergo spinal anesthesia after receiving 10 cc / kg of intravenous crystalloid solution by the executor in a sitting position on the vertebral surfaces (L5-4) or (S1-5) with needle # 26. 40 patients with marcain cc3 equivalent to 15 mg and fentanyl 0.2 cc equivalent to µ10
Category
Treatment - Drugs
2
Description
Intervention group: All patients undergo spinal anesthesia after receiving 10 cc / kg of intravenous crystalloid solution by the executor in a sitting position on the vertebral surfaces (L5- L4-) or (S1-L5) with needle # 26. 40 patients with marcaine 2.5cc equivalent to 5.12 mg and fentanyl 0.5cc equivalent to 0.25 وg and distilled water 0.2cc intrathecal
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Operating room of Imam Reza Hospital in Birjand
Full name of responsible person
Somayeh Sabaghiyan Delosi
Street address
Ghagari St.
City
Birjand
Province
South Khorasan
Postal code
9771648719
Phone
+98 56 3290 4004
Email
habibe.momeni@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Birjand University of Medical Sciences
Full name of responsible person
Toba Kazemi
Street address
Ghafari
City
Birjand
Province
South Khorasan
Postal code
9771648719
Phone
+98 56 3238 1200
Email
drtooba.kazemi@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Birjand 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
Birjand University of Medical Sciences
Full name of responsible person
Somayeh Sabaghiyan Delosi
Position
student
Latest degree
Medical doctor
Other areas of specialty/work
Anesthesiology
Street address
Ghafari St.
City
birjand
Province
South Khorasan
Postal code
9771648719
Phone
+98 56 3290 4004
Email
habibe.momeni@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Birjand University of Medical Sciences
Full name of responsible person
Somayeh Sabaghiyan Delosi
Position
student
Latest degree
Medical doctor
Other areas of specialty/work
Anesthesiology
Street address
Ghafari St.
City
birjand
Province
South Khorasan
Postal code
9777139682
Phone
+98 56 3290 4004
Email
habibe.momeni@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Birjand University of Medical Sciences
Full name of responsible person
Somayeh Sabaghiyan Delosi
Position
student
Latest degree
Medical doctor
Other areas of specialty/work
Anesthesiology
Street address
Ghafari St.
City
Birjand
Province
South Khorasan
Postal code
9777139682
Phone
+98 56 3290 4004
Email
habibe.momeni@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
Not applicable
Informed Consent Form
No - There is not 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
-
When the data will become available and for how long
-
To whom data/document is available
-
Under which criteria data/document could be used
-
From where data/document is obtainable
-
What processes are involved for a request to access data/document