To Asses the Effects of Adding Dexmedetomidine to Ropivacaine in Interscalen Block with Ultrasound Guide prior to Arthroscopically Repairing the Ruptured Shoulder Tendon Surgery in need of Amount of Anesthetic Drugs during Surgery and Post Operation Analgesia.
To asses the effects of adding Dexmedetomidine to Rupivacaine in interscallen block with ultrasound guide prior to arthroscopically repairing the ruptured shoulder tendon surgery in need of anesthetic drugs during surgery and analgesia after surgery
Design
A clinical trial with parallel, double-blind, phase 2 was performed on 42 patients.
Settings and conduct
Rasool Akram Hospital in Tehran
Participants/Inclusion and exclusion criteria
42 patients undergoing arthroscopic surgery to repair rotator cuff shoulder rupture
Intervention groups
Group 1: receive 20 cc of Rupivacaine 0.25% plus 2 cc of normal saline under the interscallen block of the brachial plexus with ultrasound guide.
Group 2: receive 20 cc of Ropivacaine 0.25% plus 1.5 µ / kg dexmethomidine under interscallen block of brachial plexus with ultrasound guide.
Main outcome variables
The addition of Dexmedetomidine to Ropivacaine in the interscallen block increases the duration of analgesia after shoulder surgery.
The addition of Dexmedetomidine to Ropivacaine in the interscallen block reduces the need for anesthetic drugs during shoulder surgery.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20181011041308N4
Registration date:2021-12-11, 1400/09/20
Registration timing:prospective
Last update:2021-12-11, 1400/09/20
Update count:0
Registration date
2021-12-11, 1400/09/20
Registrant information
Name
Mahmoud Reza Alebouyeh
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 2213 6136
Email address
alebuieh.mr@iums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-01-21, 1400/11/01
Expected recruitment end date
2022-07-23, 1401/05/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
To Asses the Effects of Adding Dexmedetomidine to Ropivacaine in Interscalen Block with Ultrasound Guide prior to Arthroscopically Repairing the Ruptured Shoulder Tendon Surgery in need of Amount of Anesthetic Drugs during Surgery and Post Operation Analgesia.
Public title
To asses the effects of adding Dexmedetomidine to Ropivacaine in interscallen block.
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients who are satisfied with their participation in the research project.
Patients undergoing elective surgery.
Patients aged between 18 and 60 years.
Exclusion criteria:
Pregnant patients.
Patients with ASA 4 and ASA 5.
Patients with asthma and copd
BMI>35
Opioid addiction and use of NSAID or opium in last 3-5 days before
Diabetic patients.
Patients with coagulopathy disorder
any AV Block changes in the ECG.
Head Trauma
Any Abnormality in arm and forearm
Any contraindications of interscalen block such as diaphragmatic paralysis in the other side
Age
From 18 years old to 60 years old
Gender
Both
Phase
2
Groups that have been masked
Participant
Care provider
Investigator
Outcome assessor
Sample size
Target sample size:
42
Randomization (investigator's opinion)
Not randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
In this study, participants were blinded by a clinical observer, caregiver, and outcome assessor.
Placebo
Not 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
Tehran Hemat Highway next to Milad Tower
City
Tehran
Province
Tehran
Postal code
1449614535
Approval date
2020-06-23, 1399/04/03
Ethics committee reference number
IR.IUMS.FMD.REC.1399.223
Health conditions studied
1
Description of health condition studied
Rupture of shoulder rotator cuff
ICD-10 code
M75.1
ICD-10 code description
Rotator cuff tear or rupture, not specified as traumatic
Primary outcomes
1
Description
1- Investigating the difference between NRS in the hours after surgery in the two groups
Timepoint
during the surgery ,2 hours, 6 hours, 18 hours and 24 hours after surgery
Method of measurement
Anesthetic recording papers,Bispectral index monitoring,ask patients
2
Description
Frequency of using the Autofuser pump in the two groups -The first hour of using the Autofuser pump in the two groups - The amount of pethidine consumption in the two groups - The first hour of using the pethidine in the two groups -Propofol consumption in both groups - Atracurium consumption in two groups - Remifentanil consumption in both groups
Timepoint
during the surgery ,2 hours, 6 hours, 18 hours and 24 hours after surgery
Method of measurement
Anesthetic recording papers,Bispectral index monitoring,ask patients
Secondary outcomes
1
Description
range of motion and frozen shoulder after 3 months and 6 months of surgery
Timepoint
3months and 6 months after surgery
Method of measurement
physical examination
Intervention groups
1
Description
Intervention group: The first group receives 20 cc of Rupivacaine 0.25% plus 2 cc of normal saline under the interscallen block of the brachial plexus with ultrasound guide. .
Category
Treatment - Drugs
2
Description
Intervention group: The second group receives 20 cc of Rupivacaine 0.25% plus 1.5 µ / kg dexmethomidine under interscallen block of the brachial plexus with ultrasound guide
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Rasoul Akram Hospital
Full name of responsible person
Shirin Zarandooz
Street address
Niyayesh St
City
Tehran
Province
Tehran
Postal code
1445613131
Phone
+98 21 6435 1000
Email
shirin_zarandouz@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Dr. Abdolreza Pazouki
Street address
Tehran Hemat Highway next to Milad Tower
City
Tehran
Province
Tehran
Postal code
1449614535
Phone
+98 21 86701
Email
PR@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
Shirin Zarandouz
Position
resident
Latest degree
Medical doctor
Other areas of specialty/work
Anesthesiology
Street address
Tehran, Hemmat Highway next to Milad Tower
City
Tehran
Province
Tehran
Postal code
1449614535
Phone
+98 912 285 8544
Email
shirin_zarandouz@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Mahmoud Reza Alebouyeh
Position
Associate professor
Latest degree
Subspecialist
Other areas of specialty/work
Anesthesiology
Street address
No 2, baharan street, Est 1 street, Saadat Abad 24 metri Blvd
City
Tehran
Province
Tehran
Postal code
1449614535
Phone
+98 21 2213 6136
Fax
Email
alebuieh.mr@iums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Mahmoud Reza Alebouyeh
Position
Associate professor
Latest degree
Subspecialist
Other areas of specialty/work
Anesthesiology
Street address
No 2, baharan street, Est 1 street, Saadat Abad 24 metri Blvd
City
Tehran
Province
Tehran
Postal code
1449614535
Phone
+98 21 2213 6136
Fax
Email
alebuieh.mr@iums.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is 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
Title and more details about the data/document
Only part of the data containing information about the main outcome can be shared.
When the data will become available and for how long
Access period starts 3 months after the results are published.
To whom data/document is available
The data will be available only to researchers working in academic and scientific institutions.
Under which criteria data/document could be used
It is necessary to send a request for access to data or documents.
From where data/document is obtainable
Refer to Dr. Mahmoud Reza Alebouyeh.
Phone: 00989121253698
What processes are involved for a request to access data/document
After submitting the request, if approved by the committee and during the legal process, the documents will be sent.