Protocol summary

Study aim
Comparison of the effect of interautal administration of bupivacaine and dextrose 5% and fentanyl on bupivacaine alone on the onset and duration of analgesia in patients undergoing lower limb orthopedic surgery
Design
Clinical trial with control group, with parallel group; Double blind, randomized
Settings and conduct
This study is being performed at Imam Reza Hospital in Birjand, South Khorasan Province. 40 patients are randomly divided into two intervention groups, one and two. After anesthesia in patients and interventions related to each group, the amount of pain in each group at 0, 6, 12 and 24 hours after surgery, patients' blood pressure, heart rate and duration of pain by the nurse in the evaluation department will be.
Participants/Inclusion and exclusion criteria
Inclusion criteria include: having informed consent, patients with ASA class one and two, age between 20 and 50 years, no drug addiction, no spinal history following surgery in the past week, no pregnancy, no brain trauma. The most recent is spinal deformity. Exclusion criteria include: patients' dissatisfaction to continue studying, duration of surgery more than 1 hour, inability to position the patient, spinal infection, sensitivity to local anesthetic drugs, high ICP and coagulation disorders.
Intervention groups
The first group under spinal by prescribing marcain 0.5% to 2 cc (10 mg) and the second group under spinal by prescribing marcain 0.5% 1 cc (5 mg) + 25 micrograms fentanyl (cc 0.5) + 0.5 cc of 5% sterile dextrose.
Main outcome variables
the pain Painless duration blood pressure heart beat

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20190618043934N2
Registration date: 2020-04-30, 1399/02/11
Registration timing: registered_while_recruiting

Last update: 2020-04-30, 1399/02/11
Update count: 0
Registration date
2020-04-30, 1399/02/11
Registrant information
Name
Zabihullah Mohaghegh
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 56 3232 3232
Email address
oabstudent@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-02-20, 1398/12/01
Expected recruitment end date
2020-06-19, 1399/03/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the effect of interautal administration of bupivacaine and dextrose 5% and fentanyl on bupivacaine alone on the onset and duration of analgesia in patients undergoing lower limb orthopedic surgery
Public title
Comparison of onset and duration of pain prescribed by combination of bupivacaine with 5% dextrose and fentanyl with bupivacaine
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Having conscious patient satisfaction Patients with ASA class one and two Age between 20 and 50 years No drug addiction No spinal history following surgery in the past week No pregnancy Nhere is no spinal deformity There is no spinal deformity
Exclusion criteria:
Patient dissatisfaction to continue studying Duration of surgery over 1 hour Inability to position the patient Spinal Infection Sensitivity to local Anesthetic Drugs High ICP Coagulation Disorders
Age
From 20 years old to 50 years old
Gender
Both
Phase
3
Groups that have been masked
  • Participant
  • Outcome assessor
Sample size
Target sample size: 20
Randomization (investigator's opinion)
Randomized
Randomization description
Individuals in each group will be randomly randomized and blocked, including spinal patients with a marcain prescription of 0.5% to cc 2 (10 mg) of group A, and the second group of spinal cord group B with a spinal margin prescription of 5 marcain. %0.5 cc 1 (mg 5) + micg 25 fentanyl (cc 0.5) + cc 0.5 dextrose will be 5% sterile. First, a variety of four blocks are created (AABB, BBAA, ABAB, BABA, ABBA, and BABA). Randomly one of these blocks is selected and patients will be divided into A or B by one of two surgical groups. Then the same is done for other patients.
Blinding (investigator's opinion)
Double blinded
Blinding description
Study participants without knowledge of the drug received for pain relief. Outcome Assessor: The ward nurse questions patients from patients without knowing the type of medication they are taking and registers them in the relevant checklist.
Placebo
Not 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
Ghafaree St
City
Birjan
Province
South Khorasan
Postal code
9717811674
Approval date
2020-02-10, 1398/11/21
Ethics committee reference number
IR.BUMS.REC.1398.351

Health conditions studied

1

Description of health condition studied
Fracture of shaft of tibia
ICD-10 code
S82.2
ICD-10 code description
Fracture of shaft of tibia

Primary outcomes

1

Description
Pain
Timepoint
0, 6, 12and 24 hours after surgery
Method of measurement
Using of VAS

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: This group under spinal by prescribing marcain 0.5% 1 cc (5 mg) + 25 micrograms fentanyl (cc 0.5) + 0.5 cc of 5% sterile dextrose.
Category
Treatment - Drugs

2

Description
Control group: this group under spinal by prescribing marcain 0.5% to 2 cc (10 mg)
Category
Treatment - Surgery

Recruitment centers

1

Recruitment center
Name of recruitment center
Imam reza hospital
Full name of responsible person
Aram Meshkini
Street address
Moallem St
City
Birjand
Province
South Khorasan
Postal code
9717811674
Phone
+98 56 3232 3232
Email
oabstudent@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Birjand University of Medical Sciences
Full name of responsible person
Dr. Tooba kazemi
Street address
Ghafaree St
City
Birjand
Province
South Khorasan
Postal code
9717811674
Phone
+98 56 3238 1200
Email
oabstudent@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
Zabihullah Mohaghegh
Position
Zabihullahmohaghegh
Latest degree
A Level or less
Other areas of specialty/work
General Practitioner
Street address
Moallem St
City
Birjand
Province
South Khorasan
Postal code
9717811674
Phone
+98 56 3232 3232
Email
oabstudent@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Birjand University of Medical Sciences
Full name of responsible person
Dr. Amirsaber Tanha
Position
Science Committee
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Taleghani Str
City
Birjand
Province
South Khorasan
Postal code
9717811674
Phone
+98 56 3232 3232
Email
oabstudent@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Birjand University of Medical Sciences
Full name of responsible person
Zabihullah Mohaghegh
Position
student
Latest degree
Bachelor
Other areas of specialty/work
General Practitioner
Street address
Moallem St
City
Birjand
Province
South Khorasan
Postal code
9717811674
Phone
+98 56 3232 3232
Email
oabstudent@gmail.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
There is no need to publish individual patient information
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
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