1. Home
  2. Approved trials
  3. » فارسی

The Effect of intra-articular injection of Dexmedetomidine on pain after knee arthroscopic surgery

Protocol summary

Study aim
This study investigated the efficacy of intra-articular injection of Dexmedetomidine in the evaluation of postoperative analgesia in patients undergoing knee arthroscopy.
Design
The clinical trial included a control group with a parallel, double-blind, randomized block design.The sample size is 70 patients which will be divided into two groups.
Settings and conduct
This study will be performed on patients who are candidates for knee arthroscopic surgery and go to Susangard Oil Martyrs Hospital in Iran. After proper cardiopulmonary monitoring and proper hydration, the patient undergoes spinal anesthesia.At the end of the arthroscopy 15 minutes before the tourniquet was opened, in one group of patients, 2μg / kg dexmedetomidine (Elixir, Iran) with normal saline 0.9% increased to 20 ml and in another group only 20 ml of normal saline 0.9% using by injection of Quincke (G-25) sterile method to the knee intra-articular space by a surgeon .The suture site will then be sutured.
Participants/Inclusion and exclusion criteria
Inclusion criteria include patients with ASA class I and II and patients aged 18 to 60 years;Exclusion criteria are: renal failure, liver failure, valvular and ischemic heart disease (indicated by patient history, physical examination and ECG and echocardiography), hypertension, diabetes, consumers opiate substances, NSAIDs and analgesics 24 hours before surgery, history of infection and malignancy, history of coagulopathy and drug allergy
Intervention groups
Intervention group: ،The effectiveness of intra-articular injection of dexmedetomidine in the amount of pain after knee arthroscopic surgery will be examined. Control group:The effectiveness of intramuscular injection of dexmedetomidine in the amount of pain after knee arthroscopy will be investigated.
Main outcome variables
Postoperative pain; Time of first analgesia; Total analgesia received.

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20200205046390N1
Registration date: 2020-06-07, 1399/03/18
Registration timing: registered_while_recruiting

Last update: 2020-06-07, 1399/03/18
Update count: 0
Registration date
2020-06-07, 1399/03/18
Registrant information
Name
Yasaman Esfahanian
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 61 3390 3016
Email address
esfahanian.y@ajums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-01-20, 1398/10/30
Expected recruitment end date
2020-09-21, 1399/06/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The Effect of intra-articular injection of Dexmedetomidine on pain after knee arthroscopic surgery
Public title
Effect of Dexmedetomidine on knee arthroscopic surgery
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients are candidates for knee arthroscopic surgery Patients with ASA class I and II
Exclusion criteria:
Renal failure Liver failure Valve and Ischemic Heart disease Hypertension Diabetes Drug users Consumer analgesics within 24 hours before surgery History of infection and malignancy History of Coagulopathy Drug reaction
Age
From 18 years old to 60 years old
Gender
Male
Phase
3
Groups that have been masked
  • Participant
  • Care provider
  • Investigator
Sample size
Target sample size: 70
Randomization (investigator's opinion)
Randomized
Randomization description
Individuals are randomly divided into two groups according to the random block permutation method. For example, for blocks of four, we have 6 blocks of AABB, ABAB, BABA, BBAA, BAAB and ABBA which must be n / 4th of these blocks as By placing the sample, the randomization unit is individualized.Random tool is statistical software. Randomization was obtained from www.sealedenevelope.com.
Blinding (investigator's opinion)
Double blinded
Blinding description
Participants are not aware of medication or placebo, despite knowing they were enrolled. The surgeon is also unaware of the contents of the injection in this study because the drug is made available to the outcome assessor. Questionnaire collectors are also unaware of the group of patients receiving the drug.
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Ahvaz Jundishapur University of Medical Sciences
Street address
No. 87, Phase 2, West 8th Street, Kianpars
City
Ahwaz
Province
Khouzestan
Postal code
6155846600
Approval date
2020-01-17, 1398/10/27
Ethics committee reference number
IR.AJUMS.REC.1398.771

Health conditions studied

1

Description of health condition studied
The effect of Dexmedetomidine on analgesia
ICD-10 code
ICD-10 code description

Primary outcomes

1

Description
Pain
Timepoint
Postoperative pain severity was assessed at 1, 2, 4, 8, 16, 24 hour after injection
Method of measurement
Visual Analogue Scale criterion (from 0 painless to 10 most painful)

2

Description
Time to receive the first analgesic
Timepoint
During the 24 hours after the operation
Method of measurement
Minutes

3

Description
Total analgesics consumption
Timepoint
During the 24 hours after the operation
Method of measurement
milligram

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: In this group of patients, 2 mg / kg dexmedetomidine (Elixir, Iran) together with normal saline 0.9% increased the volume to 20 ml, then using Needle Spinal No. 25, Quincke type is injected into the intra-articular space of the knee by sterile method.Then we will sew the place.
Category
Treatment - Drugs

2

Description
Control group:normal saline 0.9% increased the volume to 20 ml, then using Needle Spinal No. 25, Quincke type is injected into the intra-articular space of the knee by sterile method.Then we will sew the place.
Category
Placebo

Recruitment centers

1

Recruitment center
Name of recruitment center
Azadegan Plain Martyrs Hospital
Full name of responsible person
Yasaman Esfahanian
Street address
Daneshjoo Street
City
Susangerd
Province
Khouzestan
Postal code
6155846600
Phone
+98 61 3675 1014
Email
Esfahnian.Y@ajums.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Mohammad Badavi
Street address
Ground floor, Vice-Chancellor for Research and Technology, Ahvaz Jundishapur University of Medical Sciences,University City
City
Ahwaz
Province
Khouzestan
Postal code
6135715794
Phone
+98 61 3336 2414
Email
itc@ajums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Ahvaz 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
Ahvaz University of Medical Sciences
Full name of responsible person
Yasaman Esfahanian
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Anesthesiology
Street address
No. 87, Phase 2, West 8th Street, Kianpars
City
Ahwaz
Province
Khouzestan
Postal code
6155846600
Phone
00998 61 33903016
Email
Esfahanian.Y@ajums.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Yasaman Esfahanian
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Anesthesiology
Street address
No. 87, Phase 2,West 8th Street, Kianpars
City
Ahwaz
Province
Khouzestan
Postal code
6155846600
Phone
+98 61 3390 3016
Email
Esfahanian.Y@ajums.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Yasaman Esfahanian
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Anesthesiology
Street address
No. 87, Phase 2, West 8th Street, Kianpars
City
Ahwaz
Province
Khouzestan
Postal code
6155846600
Phone
+98 61 3390 3016
Email
Esfahanian.Y@ajums.ac.ir

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
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
Individual data are shared about the main outcome of the study, including the degree of analgesia and hemodynamic information of patients.
When the data will become available and for how long
Start of access period 12 months after printing results
To whom data/document is available
Researchers working in academic institutions
Under which criteria data/document could be used
In order to use the data of this study in other research and to raise awareness in the field of performance
From where data/document is obtainable
Visit Esfahanian.Y@ajums.ac.ir by email
What processes are involved for a request to access data/document
The information will be sent one week after receiving the email
Comments
Loading...