Protocol summary

Study aim
Comparison of the effect of adding dexmedetomidine or fentanyl to intrathecal ropivacaine on sensory and motor characteristics and analgesia after orthopedic lower limb surgery
Design
90 patients undergoing lower limb orthopedic surgery are divided into three groups by block randomization method. Patients in the three groups were injected with 4.5 ml of ropivacaine with 5 mg dexmedetomidine in 5 ml normal salin, 4.5 ml ropivacaine + 25 mg fentanyl in 5 ml normal salin and 4.5 ml ropivacaine 5%, respectively. Isobarics were administered in 5 cc normal salin every 15 minutes. Hemodynamic parameters, postoperative pain intensity every 15 minutes, and time to sensory and motor block arrival were also determined in three groups.
Settings and conduct
This study was performed on patients undergoing lower extremity orthopedic surgery at Alzahra Hospital, Isfahan, Iran. This study is a double blind study.
Participants/Inclusion and exclusion criteria
Inclusion criteria include: Weight less than 100 kg and Candidate Orthopedic Lower Limb Surgery and patient consent to participate in the study. Exclusion criteria included: Chronic pain report lasting more than 6 months, drug or ropivacaine sensitivity, fentanyl and dexmedetomidine, prohibition of spinal anesthesia, history of long-term drug use, or NSAIDs, or disease It is chronic.
Intervention groups
In the first group: 4.5 ml ropivacaine 3% isobaric + 5 mg dexmedetomidine is injected in 0.5 cc normal salin. In the second group: 4.5 mlRopivacaine 3% isobaric + 25 mg fentanyl is injected in 0.5 ml normal salin. In the third group: 4.5 ml ropivacaine 5% isobaric intrathecal is injected in 0.5 ml of normal salin.
Main outcome variables
Time to reach sensory block, Time to motor block, Maximum level of sensory block, Blood pressure, Heart rate, Oxygen saturation, Postoperative pain

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20130311012782N41
Registration date: 2020-03-03, 1398/12/13
Registration timing: prospective

Last update: 2020-03-03, 1398/12/13
Update count: 0
Registration date
2020-03-03, 1398/12/13
Registrant information
Name
Ali Mehrabi kushki
Name of organization / entity
Isfahan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 31 3629 1510
Email address
mehrabi@mui.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-04-02, 1399/01/14
Expected recruitment end date
2020-09-19, 1399/06/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of Dexmedetomidine and Fentanyl as Adjuvant to intrathecal Ropivacaine in Lower Limb Orthopedic Procedures
Public title
Comparison of the effect of adding dexmedetomidine or fentanyl to ropivacaine on sensory and motor characteristics and analgesia after orthopedic lower limb surgery
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Weight less than 100 kg Patient undergoing lower extremity orthopedic surgery
Exclusion criteria:
Pregnancy History of addiction or smoking, drugs and alcohol liver disease cardiovascular disease Chronic pain report lasting more than 6 months Drug sensitivity or ropivacaine, fentanyl and dexmedetomidine contraindication of spinal anesthesia Long-term drug history or opioid and NSAIDs
Age
From 18 years old to 65 years old
Gender
Both
Phase
3
Groups that have been masked
  • Participant
  • Investigator
Sample size
Target sample size: 90
Randomization (investigator's opinion)
Randomized
Randomization description
In this study, 90 patients undergoing lower limb orthopedic surgery were randomly divided into three groups of 30 each. Random allocation of patients between the three groups is done using random allocation software. At first the total sample size is entered into the software and then the number of study groups is entered. In software output, numbers 1 to 90 are randomly presented in three separate columns, according to which patients are divided into three groups according to the time of inclusion and as listed above to reach the required number in each group
Blinding (investigator's opinion)
Double blinded
Blinding description
The study was conducted in a double-blind manner and patients and researchers were uninformed with the type of drug administered. The drugs are drawn and coded on a similar syringe by an operating room staff member who is not involved in the study and provided to the plan administrator for injection.
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Isfahan University of Medical Sciences
Street address
Research faculty, Isfahan University of Medical Sciences, Hezar Jerib street, Isfahan
City
Isfahan
Province
Isfehan
Postal code
8434193474
Approval date
2020-01-19, 1398/10/29
Ethics committee reference number
IR.MUI.REC.1396.3.666

Health conditions studied

1

Description of health condition studied
Sensory and motor nerve blocks
ICD-10 code
ICD-10 code description

Primary outcomes

1

Description
Time to start sensory block
Timepoint
After the intrathecal injection of the anesthetic drug
Method of measurement
Sensory testing with no sensation of tingling with Nidel No. 23 is evaluated as subcutaneous stimulation.

Secondary outcomes

1

Description
Blood pressure
Timepoint
Every 15 minutes during surgery and recovery
Method of measurement
Pulse Oximeter

2

Description
Heart rate
Timepoint
Every 15 minutes during surgery and recovery
Method of measurement
Pulse Oximeter

3

Description
postoperative pain
Timepoint
Every 15 minutes in recovery and every 2 hour in ward
Method of measurement
With using visual Analog Scale. The criterion is a line between zero to ten and zero in the sense of no pain and ten being the most severe equivalent of the pain experienced by the patient. With this concept, the patient is asked to indicate their current pain intensity on line.

Intervention groups

1

Description
Intervention group: injection of 4.5 ml ropivacaine% isobaric + 5 micg dexmedetomidine in 5 ml normal slain
Category
Prevention

2

Description
Intervention group: Injection of 4.5 ml of isobaric ropivacaine 3% + 25 mg fentanyl in 5 ml normal slain
Category
Prevention

3

Description
Intervention group: Injection of 4.5 ml isobaric ropivacaine 3% in 5 ml normal normal slain
Category
Prevention

Recruitment centers

1

Recruitment center
Name of recruitment center
Alzahra hospital
Full name of responsible person
Mohamadjavad Hoseini
Street address
Alzahra hospital, Sofeh street
City
Isfahan
Province
Isfehan
Postal code
8434193474
Phone
+98 31 3668 5555
Email
mohammadjavadhosseini84@yahoo.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Shaghayegh Haghjoo
Street address
Research faculty, Isfahan University of Medical Sciences, Hezar Jerib street
City
Isfahan
Province
Isfehan
Postal code
8434193474
Phone
+98 31 3792 3070
Email
sh_haghjoo@med.mui.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Esfahan 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
Esfahan University of Medical Sciences
Full name of responsible person
Mohamadjavad Hoseini
Position
Resident of Anesthesiology
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Department of Anesthesiology, Alzahra hospital, Sofeh street
City
Isfahan
Province
Isfehan
Postal code
8434193474
Phone
+98 31 3668 5555
Email
mohammadjavadhosseini84@yahoo.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Reyhanak Talakoub
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Department of Anesthesiology, Alzahra hospital, Sofeh street
City
Isfahan
Province
Isfehan
Postal code
8434193474
Phone
0098 316685555
Email
talakoub@med.mui.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Ali Mehrabi
Position
Statisticlal consultant
Latest degree
Master
Other areas of specialty/work
Epidemiology
Street address
Research faculty, School of Medicin, Isfahan University of Medical Sciences, Hezaejerib street
City
Isfahan
Province
Isfehan
Postal code
8434193478
Phone
0098 37928081
Email
al.mehrabi@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
The plan is owned by the government agency and cannot be shared.
Study Protocol
No - There is not a plan to make this available
Statistical Analysis Plan
No - There is not a plan to make this available
Informed Consent Form
No - There is not a plan to make this available
Clinical Study Report
No - There is not a plan to make this available
Analytic Code
No - There is not a plan to make this available
Data Dictionary
No - There is not a plan to make this available
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