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Effect of Remifentanil on Postoperative Pain in Knee Arthroscopic Surgery; a Randomized Controlled Clinical Trial

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History
# Registration date Revision Id
2 2021-03-24, 1400/01/04 176355
1 2020-01-04, 1398/10/14 116687
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  • Protocol summary

    In this double blind randomized clinical trial study, 60 patients were studied in educational, research and medical centers of Mashhad University of Medical Sciences between 2018 and 2020. Individuals were candidates for knee surgery with arthroscopic ASA grade one and two will be entered in this study. Then patients who had the inclusion criteria will be randomly divided into two groups. The first group included patients receiving intra-articular remifentanil and the second group (control) included those receiving the same volume of normal intra-articular saline. The physician will then inject the patient without knowing the solution used. Then the patients in the intervention group will be injected with remifentanil in the control group and normal intra-articular saline at the end of surgery.
    In this double blind randomized clinical trial study, 60 patients were studied in Imam Reza hospital Mashhad, Iran between 2018 and 2020. Individuals were candidates for knee surgery with arthroscopic ASA grade one and two will be entered in this study. Then patients who had inclusion criteria will be randomly divided into two groups. The first group included patients receiving intra-articular remifentanil and the second group (control) included those receiving the same volume of normal intra-articular saline. The physician will then inject the patient without knowing the solution used.
    Inclusion criteria: Individuals who completed the Consciousness Questionnaire for Arthroscopic Knee Arthroscopy and were candidates for Knee Arthroscopy Surgery according to American Society of Anesthesiologists Classification Class One and Two . Exclusion criteria: Using opioids Using Nonsteroidal anti-inflammatory drugs in 24 hours before surgery Diabetic neuropathy Neuromuscular diseases People with a history of infection and malignancy Knee surgery history (patients requiring any procedure except knee arthroscopic meniscectomy) History of medicinal allergies.
    Inclusion criteria: Individuals who completed the Consciousness Questionnaire for Arthroscopic Knee Arthroscopy and were candidates for Knee Arthroscopy Surgery according to American Society of Anesthesiologists Classification Class One and Two . Exclusion criteria: Using opioids Using Nonsteroidal anti-inflammatory drugs in 24 hours before surgery Diabetic neuropathy Neuromuscular diseases People with a history of infection and malignancy Knee surgery history (patients requiring any procedure except knee arthroscopic meniscectomy) History of medicinal allergies history of renal failure liver dysfunction ischemic and valvular heart disease cases required repeated opioid intake during surgery, complicated knee surgery hypertension
    معيار ورود به مطالعه : افرادی که جهت آرتروسكوپي منيسك زانو پرسش نامه رضایت آگاهانه را تکمیل و كانديد جراحي آرتروسكوپي منيسك زانو بر اساس طبقه بندی جامعه بیهوشی آمریکا در کلاس یک و دو باشند . معيار عدم ورود به مطالعه: مصرف مواد مخدر استفاده از داروهای ضد التهاب غیر استروئیدی در 24 ساعت قبل از عمل نروپاتي ديابتّ بيماريهاي نروماسكولار افراد با سابقه عفونت و بدخیمی سابقه عمل زانو(بیمارانی که نیازمند هر نوع روش به جز منیسکتومی آرتروسکوپی زانو) سابقه آلرژی دارویی
    معيار ورود به مطالعه : افرادی که جهت آرتروسكوپي منيسك زانو پرسش نامه رضایت آگاهانه را تکمیل و كانديد جراحي آرتروسكوپي منيسك زانو بر اساس طبقه بندی جامعه بیهوشی آمریکا در کلاس یک و دو باشند . معيار عدم ورود به مطالعه: مصرف مواد مخدر استفاده از داروهای ضد التهاب غیر استروئیدی در 24 ساعت قبل از عمل نروپاتي ديابتّ بيماريهاي نروماسكولار افراد با سابقه عفونت و بدخیمی سابقه عمل زانو(بیمارانی که نیازمند هر نوع روش به جز منیسکتومی آرتروسکوپی زانو) سابقه آلرژی دارویی مواردی که نیازمند دریافت مکرر اپیوئید در طول عمل جراحی بودند سابقه نارسایی کلیوی، اختلال عملکرد کبد، بیماری های ایسکمیک و دریچه ای قلبی جراحی زانو عارضه دار فشار خون

  • General information

    Not randomized
    Randomized
    1
    Not used
    Used
    empty
    Primary version has some errors and was not complete
    empty
    نسخه ی اولیه اشتباهاتی داشت و کامل نوشته نشده بود
    Using opioids
    Using Nonsteroidal anti-inflammatory drugs in 24 hours before surgery
    Diabetic neuropathy
    Neuromuscular diseases
    People with a history of infection and malignancy
    Knee surgery history (patients requiring any procedure except knee arthroscopic meniscectomy)
    History of medicinal allergies
    Using opioids
    Using Nonsteroidal anti-inflammatory drugs in 48 hours before surgery
    Diabetic neuropathy
    Neuromuscular diseases
    People with a history of infection and malignancy
    Knee surgery history (patients requiring any procedure except knee arthroscopic meniscectomy)
    History of medicinal allergies
    history of renal failure
    liver dysfunction
    ischemic and valvular heart disease
    cases that required repeated opioid intake during surgery
    patients with complicated knee surgery
    مصرف مواد مخدر
    استفاده از داروهای ضد التهاب غیر استروئیدی در 24 ساعت قبل از عمل
    نروپاتي ديابتّ
    بيماريهاي نروماسكولار
    افراد با سابقه عفونت و بدخیمی
    سابقه عمل زانو(بیمارانی که نیازمند هر نوع روش به جز منیسکتومی آرتروسکوپی زانو)
    سابقه آلرژی دارویی
    مصرف مواد مخدر
    استفاده از داروهای ضد التهاب غیر استروئیدی در 48 ساعت قبل از عمل
    نروپاتي ديابتّ
    بيماريهاي نروماسكولار
    افراد با سابقه عفونت و بدخیمی
    سابقه عمل زانو(بیمارانی که نیازمند هر نوع روش به جز منیسکتومی آرتروسکوپی زانو)
    سابقه آلرژی دارویی
    سابقه نارسایی کلیه
    اختلال عملکرد کبدی
    بیماری های ایسکمیک یا دریچه ای قلب
    بیمارانی که درخواست مکرر در طی جراحی میکنند
    بیماران با عمل جراحی عارضه دار همراه بودند
    Computer generated randomization, using www.randomization.com
    اعاد تصادفی تولید شده کامپیوتری (سایت www.randomization.com )

  • Recruitment centers

    #1
    Name of recruitment center - English: Ghaem Hospital
    Name of recruitment center - Persian: بيمارستان قائم
    Full name of responsible person - English: Dr Mohammad Alipour
    Full name of responsible person - Persian: دکتر محمد عليپور
    Street address - English: Ghaem Hospital, Taghi Abad Square
    Street address - Persian: ميدان تقي آباد، بيمارستان قائم(عج)
    City - English: Mashhad
    City - Persian: مشهد
    Province: Razavi Khorasan
    Country: Iran (Islamic Republic of)
    Postal code: 91766-99199
    Phone: +98 51 3840 0000
    Fax:
    Email: Quaem.Medical.Center@mums.ac.ir
    Web page address:
    Name of recruitment center - English: Imam Reza Hospital
    Name of recruitment center - Persian: بيمارستان امام رضا
    Full name of responsible person - English: Dr Mohammad Alipour
    Full name of responsible person - Persian: دکتر محمد عليپور
    Street address - English: Ghaem Hospital, Taghi Abad Square
    Street address - Persian: ميدان تقي آباد، بيمارستان قائم(عج)
    City - English: Mashhad
    City - Persian: مشهد
    Province: Razavi Khorasan
    Country: Iran (Islamic Republic of)
    Postal code: 91766-99199
    Phone: +98 51 3840 0000
    Fax:
    Email: Quaem.Medical.Center@mums.ac.ir
    Web page address:

Protocol summary

Study aim
Reduction of pain and hospitalization of patients undergoing knee arthroscopy by intra-articular injection of remifentanil
Design
The present study is a double-blind that Phase of clinical trial is phase 2-3 with 60 patients undergoing meniscus knee arthroscopy.
Settings and conduct
In this double blind randomized clinical trial study, 60 patients were studied in Imam Reza hospital Mashhad, Iran between 2018 and 2020. Individuals were candidates for knee surgery with arthroscopic ASA grade one and two will be entered in this study. Then patients who had inclusion criteria will be randomly divided into two groups. The first group included patients receiving intra-articular remifentanil and the second group (control) included those receiving the same volume of normal intra-articular saline. The physician will then inject the patient without knowing the solution used.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Individuals who completed the Consciousness Questionnaire for Arthroscopic Knee Arthroscopy and were candidates for Knee Arthroscopy Surgery according to American Society of Anesthesiologists Classification Class One and Two . Exclusion criteria: Using opioids Using Nonsteroidal anti-inflammatory drugs in 24 hours before surgery Diabetic neuropathy Neuromuscular diseases People with a history of infection and malignancy Knee surgery history (patients requiring any procedure except knee arthroscopic meniscectomy) History of medicinal allergies history of renal failure liver dysfunction ischemic and valvular heart disease cases required repeated opioid intake during surgery, complicated knee surgery hypertension
Intervention groups
Intervention group: intra-articular injection of Remifentanil will be done. Control group: placebo intra-articular injection will be done.
Main outcome variables
Pain

General information

Reason for update
Primary version has some errors and was not complete
Acronym
IRCT registration information
IRCT registration number: IRCT20191017045137N1
Registration date: 2020-01-04, 1398/10/14
Registration timing: registered_while_recruiting

Last update: 2021-03-27, 1400/01/07
Update count: 1
Registration date
2020-01-04, 1398/10/14
Registrant information
Name
Azita Farahi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 51 3858 3878
Email address
azitafarahi1398@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-04-11, 1398/01/22
Expected recruitment end date
2020-04-11, 1399/01/23
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of Remifentanil on Postoperative Pain in Knee Arthroscopic Surgery; a Randomized Controlled Clinical Trial
Public title
Effect of Remifentanil on Postoperative Pain in Knee Arthroscopic Surgery
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Candidate for Knee Arthroscopic Surgery American Society of Anesthesiologists Classification Class One and Two
Exclusion criteria:
Using opioids Using Nonsteroidal anti-inflammatory drugs in 48 hours before surgery Diabetic neuropathy Neuromuscular diseases People with a history of infection and malignancy Knee surgery history (patients requiring any procedure except knee arthroscopic meniscectomy) History of medicinal allergies history of renal failure liver dysfunction ischemic and valvular heart disease cases that required repeated opioid intake during surgery patients with complicated knee surgery
Age
No age limit
Gender
Both
Phase
2-3
Groups that have been masked
  • Participant
  • Care provider
  • Investigator
Sample size
Target sample size: 60
Randomization (investigator's opinion)
Randomized
Randomization description
Computer generated randomization, using www.randomization.com
Blinding (investigator's opinion)
Double blinded
Blinding description
Patients and the person who injects the drug do not aware of the type of drug.
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Mashhad University of Medical Sciences
Street address
Ghaem Hospital
City
Mashhad
Province
Razavi Khorasan
Postal code
9137913316
Approval date
2019-07-09, 1398/04/18
Ethics committee reference number
IR.MUMS.MEDICAL.REC.1398.614

Health conditions studied

1

Description of health condition studied
Knee Meniscus Injury
ICD-10 code
S83.7
ICD-10 code description
Injury to multiple structures of knee

Primary outcomes

1

Description
Pain
Timepoint
After surgery
Method of measurement
Visual Analogue Scale

Secondary outcomes

empty

Intervention groups

1

Description
The intervention group will receive 200 µg of Remifentanil, 25 ml volume dissolved in normal saline at the end of surgery by an orthopedic colleague who is unaware of the drug.
Category
Prevention

2

Description
Control group: 25 cc of normal saline intra-articular will be injected at the end of surgery.
Category
Prevention

Recruitment centers

1

Recruitment center
Name of recruitment center
Imam Reza Hospital
Full name of responsible person
Dr Mohammad Alipour
Street address
Ghaem Hospital, Taghi Abad Square
City
Mashhad
Province
Razavi Khorasan
Postal code
91766-99199
Phone
+98 51 3840 0000
Email
Quaem.Medical.Center@mums.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Vice Chancellor for Research, Mashhad University of Medical Science
Street address
Vice Chancellor for Research, Mashhad University of Medical Science, Ghoreishi apartment, Daneshgah street
City
Mashhad
Province
Razavi Khorasan
Postal code
9138813944
Phone
+98 51 3841 2081
Email
Ramresearch@mums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Mashhad 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
Mashhad University of Medical Sciences
Full name of responsible person
Dr Mohammad Alipour
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Ghaem Hospital
City
Mashhad
Province
Razavi Khorasan
Postal code
91766-99199
Phone
+98 51 3840 0000
Email
farahi.azita@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Azita Farahi
Position
Mashhad
Latest degree
Medical doctor
Other areas of specialty/work
Anesthesiology
Street address
Ghaem Hospital, Ahmadabad Street
City
Mashhad
Province
Razavi Khorasan
Postal code
91766-99199
Phone
+98 51 3840 0000
Email
Farahi.azita@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Mohammad Alipour
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Ahmadabad Street
City
Mashhad
Province
Razavi Khorasan
Postal code
91766-99199
Phone
+98 51 3845 3239
Email
alipourm@mums.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
Not applicable
Title and more details about the data/document
As a research paper
When the data will become available and for how long
2020
To whom data/document is available
researchers
Under which criteria data/document could be used
medical students
From where data/document is obtainable
sent an email
What processes are involved for a request to access data/document
sent an email
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