The Comparison between intraarticular knee injection (Morphine, ketorolac) with and without Tranxamic acid following arthroscopic ACL reconstruction surgery in reducing pain and assessing functional outcomes in patient with isolated ACL injury
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Protocol summary
A controlled, parallel-group, double-blind, randomized, phase 3 clinical trial on 98 patients. For randomization, the random numbers given to each of them by the computer enter the control group or the intervention group.
A controlled, parallel-group, double-blind, randomized, phase 3 clinical trial on 100 patients. For randomization, the random numbers given to each of them by the computer enter the control group or the intervention group.
A controlled, parallel-group, double-blind, randomized, phase 3 clinical trial on 98100 patients. For randomization, the random numbers given to each of them by the computer enter the control group or the intervention group.
کارآزمایی بالینی دارای گروه کنترل، با گروه های موازی، دو سویه کور، تصادفی شده، فاز 3 بر روی 98 بیمار. برای تصادفی سازی از شماره های رندومی که توسط رایانه به هر کدام از انها داده می شود وارد گروه کنترل یا گروه مورد مداخله می شوند
کارآزمایی بالینی دارای گروه کنترل، با گروه های موازی، دو سویه کور، تصادفی شده، فاز 3 بر روی 100 بیمار. برای تصادفی سازی از شماره های رندومی که توسط رایانه به هر کدام از انها داده می شود وارد گروه کنترل یا گروه مورد مداخله می شوند
کارآزمایی بالینی دارای گروه کنترل، با گروه های موازی، دو سویه کور، تصادفی شده، فاز 3 بر روی 98100 بیمار. برای تصادفی سازی از شماره های رندومی که توسط رایانه به هر کدام از انها داده می شود وارد گروه کنترل یا گروه مورد مداخله می شوند
Intervention group:
30mg Ketorolac ampoule(1cc)
5mg morphine sulfate(0.5cc)
1gr Tranexamic acid (10cc)
28.5cc of normal saline solution
Control group:
30mg Ketorolac ampoule(1cc)
5mg morphine sulfate(0.5cc)
38.5cc of normal saline solution
Intervention group:
30mg Ketorolac ampoule(1cc)
5mg morphine sulfate(0.5cc)
1gr Tranexamic acid (10cc)
100 mg of lidocaine (5 cc)
23.5cc of normal saline solution
Control group:
30mg Ketorolac ampoule(1cc)
5mg morphine sulfate(0.5cc)
100 mg of lidocaine (5 cc)
33.5cc of normal saline solution
Intervention group: 30mg Ketorolac ampoule(1cc) 5mg morphine sulfate(0.5cc) 1gr Tranexamic acid (10cc) 28.5cc100 mg of lidocaine (5 cc) 23.5cc of normal saline solution Control group: 30mg Ketorolac ampoule(1cc) 5mg morphine sulfate(0.5cc) 38.5cc100 mg of lidocaine (5 cc) 33.5cc of normal saline solution
گروه مورد مداخله :
30 میلی گرم آمپول کتورولاک (Ketorolac) (1 سی سی)
5 میلی گرم مورفین سولفات (0.5 سی سی)
1 گرم ترانزامیک اسید (TXA) (10 سی سی)
28.5 سی سی محلول نرمال سالین
گروه کنترل:
30 میلی گرم آمپول کتورولاک (Ketorolac) (1 سی سی)
5 میلی گرم مورفین سولفات (0.5 سی سی)
38.5 سی سی محلول نرمال سالین
گروه مورد مداخله :
30 میلی گرم آمپول کتورولاک (Ketorolac) (1 سی سی)
5 میلی گرم مورفین سولفات (0.5 سی سی)
1 گرم ترانزامیک اسید (TXA) (10 سی سی)
100 میلیگرم لیدوکایین
28.5 سی سی محلول نرمال سالین
گروه کنترل:
30 میلی گرم آمپول کتورولاک (Ketorolac) (1 سی سی)
5 میلی گرم مورفین سولفات (0.5 سی سی)
100 میلیگرم لیدوکایین
38.5 سی سی محلول نرمال سالین
گروه مورد مداخله : 30 میلی گرم آمپول کتورولاک (Ketorolac) (1 سی سی) 5 میلی گرم مورفین سولفات (0.5 سی سی) 1 گرم ترانزامیک اسید (TXA) (10 سی سی) 100 میلیگرم لیدوکایین 28.5 سی سی محلول نرمال سالین گروه کنترل: 30 میلی گرم آمپول کتورولاک (Ketorolac) (1 سی سی) 5 میلی گرم مورفین سولفات (0.5 سی سی) 100 میلیگرم لیدوکایین 38.5 سی سی محلول نرمال سالین
General information
Double blinded
Triple blinded
doubltripl
1
1
98
100
98100
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100
100
2023-02-09, 1401/11/20
2022-04-01, 1401/01/12
20232022-0204-0901 00:00:00
2024-03-19, 1402/12/29
2023-10-31, 1402/08/09
20242023-0310-1931 00:00:00
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2022-04-01, 1401/01/12
2022-04-01 00:00:00
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2023-10-31, 1402/08/09
2023-10-31 00:00:00
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2024-01-29, 1402/11/09
2024-01-29 00:00:00
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updating some of protocol fields
updating some of protocol fields
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مطابقت پروتوکل با متن مقاله
مطابقت پروتوکل با متن مقاله
The Comparison between intraarticular knee injection (Morphine, , ketorolac) with and without Tranxamic acid following arthroscopic ACL reconstruction surgery in reducing pain and assessing functional outcomes in patient with isolated ACL injury
The Comparison between intraarticular knee injection (Morphine, ketorolac) with and without Tranxamic acid following arthroscopic ACL reconstruction surgery in reducing pain and assessing functional outcomes in patient with isolated ACL injury
The Comparison between intraarticular knee injection (Morphine, , ketorolac) with and without Tranxamic acid following arthroscopic ACL reconstruction surgery in reducing pain and assessing functional outcomes in patient with isolated ACL injury
Exclusive tear of the anterior cruciate ligament or ACL
Age more than 15 years and less than 60 years
Weight less than 100 kg
Ability to read and write to give informed written consent and cooperate in the study
Use of hamstring autograft
an isolated, unilateral, chronic ACL tear
Ability to read and write to give informed written consent and cooperate in the study
Use of hamstring autograft
American Society of Anesthesiologists (ASA) physical status of I
Exclusive tear of the anterior cruciate ligament oran isolated, unilateral, chronic ACL Age more than 15 years and less than 60 years Weight less than 100 kgtear Ability to read and write to give informed written consent and cooperate in the study Use of hamstring autograft American Society of Anesthesiologists (ASA) physical status of I
پارگی انحصاری رباط صلیبی قدامی یا ACL
سن بیشتر از 15 سال و کم تر از 60 سال
وزن کمتر از 100 کیلوگرم
توانایی خواندن و نوشتن جهت دادن رضایت کتبی آگاهانه و همکاری در مطالعه
استفاده از اتوگرافت هامسترینگ
پارگی انحصاری رباط صلیبی قدامی یا ACL
توانایی خواندن و نوشتن جهت دادن رضایت کتبی آگاهانه و همکاری در مطالعه
استفاده از اتوگرافت هامسترینگ
نمره ASA یک
پارگی انحصاری رباط صلیبی قدامی یا ACL سن بیشتر از 15 سال و کم تر از 60 سال وزن کمتر از 100 کیلوگرم توانایی خواندن و نوشتن جهت دادن رضایت کتبی آگاهانه و همکاری در مطالعه استفاده از اتوگرافت هامسترینگ نمره ASA یک
Drug sensitivity
History of drug dependence
Neurological and psychiatric problems, heart, kidney, or liver disease, and cardiac arrhythmia
Diabetes
Neuromuscular disease
Inflammatory joint arthritis such as rheumatoid arthritis
Use of allograft
Performing accompanying osteotomy surgery
Presence of accompanying cartilage damage or meniscal tear
Drug sensitivity
multi-ligament injuries
bilateral ACL tears
acute ACL tears
bony deformities
a history of hematologic conditions or ischemic attacks
patients receiving anticoagulant therapy
Drug sensitivity Historymulti-ligament injuries bilateral ACL tears acute ACL tears bony deformities a history of drug dependence Neurological and psychiatric problems, heart, kidney,hematologic conditions or liver disease, and cardiac arrhythmia Diabetes Neuromuscular disease Inflammatory joint arthritis such as rheumatoid arthritis Use of allograft Performing accompanying osteotomy surgery Presence of accompanying cartilage damage or meniscal tearischemic attacks patients receiving anticoagulant therapy
حساسیت دارویی
سابقه وابستگی دارویی
مشکلات نورولوژیک و روانپزشکی، بیماری قلبی کلیوی کبدی و اریتمی قلبی
دیابت
بیماری نوروماسکولار
ارتریت التهابی مفصلی نظیر ارتریت روماتویید
استفاده از آلوگرافت
انجام جراحی استوتومی همراه
وجود آسیب غضروفی یا پارگی منیسک همراه
حساسیت دارویی
وجود آسیب غضروفی یا پارگی منیسک همراه
پارگی دو طرفه
پارگی حاد
دفورمیتی های استخوان
سابقه بیماری قلبی
سابقه دریافت دارو ضد انعقاد
حساسیت دارویی سابقه وابستگی دارویی مشکلات نورولوژیک و روانپزشکی، بیماری قلبی کلیوی کبدی و اریتمی قلبی دیابت بیماری نوروماسکولار ارتریت التهابی مفصلی نظیر ارتریت روماتویید استفاده از آلوگرافت انجام جراحی استوتومی همراه وجود آسیب غضروفی یا پارگی منیسک همراه پارگی دو طرفه پارگی حاد دفورمیتی های استخوان سابقه بیماری قلبی سابقه دریافت دارو ضد انعقاد
Table of random numbers (two block) by site randomization.com
Table of random numbers (four block) by site randomization.com
Table of random numbers (twofour block) by site randomization.com
Primary outcomes
#1
The pain level of the patients is based on the Visual Analoque Scale or VAS with a score from 1 to 10, which is measured in the intervals of one hour, two hours, 3 hours, 6 hours, 12 hours, 24 hours, one week, one month and three months after the operation.
The pain level of the patients is based on the Visual Analoque Scale or VAS with a score from 1 to 10, which is measured in the intervals of one hour, two hours, 3 hours, 6 hours, 12 hours, one week, one month and three months after the operation.
The pain level of the patients is based on the Visual Analoque Scale or VAS with a score from 1 to 10, which is measured in the intervals of one hour, two hours, 3 hours, 6 hours, 12 hours, 24 hours, one week, one month and three months after the operation.
میزان درد بیماران بر اساس Visual Analogue Scale یا VAS با امتیاز از 1 تا 10 که در بازه های یک ساعت، دو ساعت، 3 ساعت، 6 ساعت، 12 ساعت، 24 ساعت، یک هفته، یک ماه و سه ماه بعد از عمل سنجیده خواهد شد.
میزان درد بیماران بر اساس Visual Analogue Scale یا VAS با امتیاز از 1 تا 10 که در بازه های یک ساعت، دو ساعت، 3 ساعت، 6 ساعت، 12 ساعت، یک هفته، یک ماه و سه ماه بعد از عمل سنجیده خواهد شد.
میزان درد بیماران بر اساس Visual Analogue Scale یا VAS با امتیاز از 1 تا 10 که در بازه های یک ساعت، دو ساعت، 3 ساعت، 6 ساعت، 12 ساعت، 24 ساعت، یک هفته، یک ماه و سه ماه بعد از عمل سنجیده خواهد شد.
#2
Functional variables in patients including Lysholm
Functional variables in patients including Knee Injury and Osteoarthritis Outcome Score (KOOS).
Functional variables in patients including LysholmKnee Injury and Osteoarthritis Outcome Score (KOOS).
بهبود عملکرد بیمار با کسب امتیاز بالای پرسشنامه Lysholm
بهبود عملکرد بیمار با کسب امتیاز بالای پرسشنامه Knee Injury and Osteoarthritis Outcome Score (KOOS) .
بهبود عملکرد بیمار با کسب امتیاز بالای پرسشنامه LysholmKnee Injury and Osteoarthritis Outcome Score (KOOS) .
Lysholm questionnaire score from 0 to 100, before surgery, one hour, one month and three months after surgery.
It is measured before surgery, one month and three months after surgery.
Lysholm questionnaire score from 0 to 100,It is measured before surgery, one hour, one month and three months after surgery.
امتیاز پرسشنامه Lysholm از امتیاز 0 تا 100، قبل از جراحی، یک هقته، یک ماه و سه ماه بعد از جراحی
قبل از جراحی، یک ماه و سه ماه بعد از جراحی سنجیده می شود.
امتیاز پرسشنامه Lysholm از امتیاز 0 تا 100، قبل از جراحی، یک هقته، یک ماه و سه ماه بعد از جراحی سنجیده می شود.
The performance of all patients is completed and evaluated based on the Lysholm questionnaire
The score of the KOOS or Knee injury and Osteoarthritis Outcome Score questionnaire examines the patient in 5 areas and its score is 0 to 100%.
The performancescore of all patientsthe KOOS or Knee injury and Osteoarthritis Outcome Score questionnaire examines the patient in 5 areas and its score is completed and evaluated based on the Lysholm questionnaire0 to 100%.
عملکرد تمام بیماران براساس پرسشنامه Lysholm تکمیل و ارزیابی می شود
امتیاز پرسشنامه KOOS یا Knee injury and Osteoarthritis Outcome Score در 5 حوزه بیمار را مورد بررسی قرار می دهد و امتیاز آن 0 تا 100 درصد می باشد.
عملکرد تمام بیماران براساسامتیاز پرسشنامه Lysholm تکمیلKOOS یا Knee injury and Osteoarthritis Outcome Score در 5 حوزه بیمار را مورد بررسی قرار می دهد و ارزیابیامتیاز آن 0 تا 100 درصد می شودباشد.
#3
Functional variables in patients including Knee Injury and Osteoarthritis Outcome Score (KOOS).
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Functional variables in patients including Knee Injury and Osteoarthritis Outcome Score (KOOS).
بهبود عملکرد بیمار با کسب امتیاز بالای پرسشنامه Knee Injury and Osteoarthritis Outcome Score (KOOS) .
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بهبود عملکرد بیمار با کسب امتیاز بالای پرسشنامه Knee Injury and Osteoarthritis Outcome Score (KOOS) .
It is measured before surgery, one month and three months after surgery.
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It is measured before surgery, one month and three months after surgery.
قبل از جراحی، یک ماه و سه ماه بعد از جراحی سنجیده می شود.
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قبل از جراحی، یک ماه و سه ماه بعد از جراحی سنجیده می شود.
The score of the KOOS or Knee injury and Osteoarthritis Outcome Score questionnaire examines the patient in 5 areas and its score is 0 to 100%.
empty
The score of the KOOS or Knee injury and Osteoarthritis Outcome Score questionnaire examines the patient in 5 areas and its score is 0 to 100%.
امتیاز پرسشنامه KOOS یا Knee injury and Osteoarthritis Outcome Score در 5 حوزه بیمار را مورد بررسی قرار می دهد و امتیاز آن 0 تا 100 درصد می باشد.
empty
امتیاز پرسشنامه KOOS یا Knee injury and Osteoarthritis Outcome Score در 5 حوزه بیمار را مورد بررسی قرار می دهد و امتیاز آن 0 تا 100 درصد می باشد.
Secondary outcomes
#1
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Functional variables in patients including Lysholm
Functional variables in patients including Lysholm
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بهبود عملکرد بیمار با کسب امتیاز بالای پرسشنامه Lysholm
بهبود عملکرد بیمار با کسب امتیاز بالای پرسشنامه Lysholm
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Lysholm questionnaire score from 0 to 100, before surgery, one hour, one month and three months after surgery.
Lysholm questionnaire score from 0 to 100, before surgery, one hour, one month and three months after surgery.
empty
امتیاز پرسشنامه Lysholm از امتیاز 0 تا 100، قبل از جراحی، یک هقته، یک ماه و سه ماه بعد از جراحی
امتیاز پرسشنامه Lysholm از امتیاز 0 تا 100، قبل از جراحی، یک هقته، یک ماه و سه ماه بعد از جراحی
empty
The performance of all patients is completed and evaluated based on the Lysholm questionnaire
The performance of all patients is completed and evaluated based on the Lysholm questionnaire
empty
عملکرد تمام بیماران براساس پرسشنامه Lysholm تکمیل و ارزیابی می شود
عملکرد تمام بیماران براساس پرسشنامه Lysholm تکمیل و ارزیابی می شود
Intervention groups
#1
Control group: Intra-articular injection of 40 cc of analgesic cocktail after surgery including: 30 mg Ketorolac ampoule (1 cc), 5 mg of morphine sulfate (0.5 cc), 38.5 cc of normal solution Saline; All made by Iranian pharmaceutical companies
Control group: Intra-articular injection of 40 cc of analgesic cocktail after surgery including: 30 mg Ketorolac ampoule (1 cc), 5 mg of morphine sulfate (0.5 cc),100 mg of lidocaine (5 cc), 33.5 cc of normal solution Saline; All made by Iranian pharmaceutical companies
Control group: Intra-articular injection of 40 cc of analgesic cocktail after surgery including: 30 mg Ketorolac ampoule (1 cc), 5 mg of morphine sulfate (0.5 cc),100 mg of lidocaine (5 cc), 38.533.5 cc of normal solution Saline; All made by Iranian pharmaceutical companies
#2
Intervention group: Intra-articular injection of 40 cc of analgesic cocktail after surgery including: 30 mg Ketorolac ampoule (1 cc), 5 mg of morphine sulfate (0.5 cc), 1 gram of tranexamic acid (TXA) (10 cc) 28.5 cc normal saline solution; All made by Iranian pharmaceutical companies
Intervention group: Intra-articular injection of 40 cc of analgesic cocktail after surgery including: 30 mg Ketorolac ampoule (1 cc), 5 mg of morphine sulfate (0.5 cc), 1 gram of tranexamic acid (TXA) (10 cc)100 mg of lidocaine (5 cc) 23.5 cc normal saline solution; All made by Iranian pharmaceutical companies
Intervention group: Intra-articular injection of 40 cc of analgesic cocktail after surgery including: 30 mg Ketorolac ampoule (1 cc), 5 mg of morphine sulfate (0.5 cc), 1 gram of tranexamic acid (TXA) (10 cc)100 mg of lidocaine (5 cc) 28.523.5 cc normal saline solution; All made by Iranian pharmaceutical companies
Recruitment centers
#1
Name of recruitment center - English: Imam Khomeini Hospital,Tehran,Iran
Name of recruitment center - Persian: بیمارستان امام خمینی تهران
Full name of responsible person - English: Mohammad Ayati Firozabadi
Full name of responsible person - Persian: محمد آیتی فیروزآبادی
Street address - English: Emam Khomeini Hospital, Orthopedic Department, Joint Reconstruction Research Center, Chamran Highway, Baqerkhan East Street
Street address - Persian: اتوبان چمران،خیابان باقرخان شرقی،بیمارستان امام خمینی،بخش ارتوپدی،مرکز تحقیقات بازسازی مفاصل
City - English: Tehran
City - Persian: تهران
Province: Tehran
Country: Iran (Islamic Republic of)
Postal code: ۱۴۱۹۷۳۳۱۴۱
Phone: +98 21 6658 1653
Fax:
Email: dr.mohammad.ayati@gmail.com
Web page address:
Name of recruitment center - English: Imam Khomeini Hospital Complex, Tohid Squre, Tehran, Iran
Name of recruitment center - Persian: بیمارستان امام خمینی تهران
Full name of responsible person - English: Mohammad Ayati Firozabadi
Full name of responsible person - Persian: محمد آیتی فیروزآبادی
Street address - English: Joint Reconstruction Research Center, Orthopedic Department, Imam Khomeini Hospital Complex, Tohid Squre, Tehran, Iran
Street address - Persian: اتوبان چمران، خیابان باقرخان شرقی، بیمارستان امام خمینی، بخش ارتوپدی، مرکز تحقیقات بازسازی مفاصل
City - English: Tehran
City - Persian: تهران
Province: Tehran
Country: Iran (Islamic Republic of)
Postal code: ۱۴۱۹۷۳۳۱۴۱
Phone: +98 21 6658 1653
Fax:
Email: dr.mohammad.ayati@gmail.com
Web page address:
Name of recruitment center - English: Imam Khomeini Hospital,Tehran,IranHospital Complex, Tohid Squre, Tehran, Iran Name of recruitment center - Persian: بیمارستان امام خمینی تهران Full name of responsible person - English: Mohammad Ayati Firozabadi Full name of responsible person - Persian: محمد آیتی فیروزآبادی Street address - English: Emam Khomeini Hospital, Orthopedic Department, Joint Reconstruction Research Center, Chamran HighwayOrthopedic Department, Baqerkhan East StreetImam Khomeini Hospital Complex, Tohid Squre, Tehran, Iran Street address - Persian: اتوبان چمران،خیابان باقرخان شرقی،بیمارستان امام خمینی،بخش ارتوپدی،مرکز تحقیقات بازسازی مفاصل City - English: Tehran City - Persian: تهران Province: Tehran Country: Iran (Islamic Republic of) Postal code: ۱۴۱۹۷۳۳۱۴۱ Phone: +98 21 6658 1653 Fax: Email: dr.mohammad.ayati@gmail.com Web page address:
Sponsors / Funding sources
#1
Name of organization / entity - English:
Name of organization / entity - Persian:
Full name of responsible person - English: Dr. Akbar Fatuhi
Full name of responsible person - Persian: دکتر اکبر فتوحی
Street address - English: Keshavarz Blvd., corner of Quds St., Central Organization of the University, 6th floor of Research and Technology Vice-Chancellor
Street address - Persian: لوار کشاورز، نبش خیابان قدس، سازمان مرکزی دانشگاه، طبقه ششم معاونت تحقیقات و فناوری
City - English: Tehran
City - Persian: تهران
Province: Tehran
Country: Iran (Islamic Republic of)
Postal code: ۱۴۱۹۷۳۳۱۴۱
Phone: +98 21 8163 3685
Fax:
Email: vcr@tums.ac.ir
Web page address: https://vcr.tums.ac.ir/
Name of organization / entity - English:
Name of organization / entity - Persian:
Full name of responsible person - English: Dr. Akbar Fatuhi
Full name of responsible person - Persian: دکتر اکبر فتوحی
Street address - English: 6th floor of Research and Technology Vice-Chancellor, Central Organization of the Tehran University, Keshavarz Blvd
Street address - Persian: بلوار کشاورز، نبش خیابان قدس، سازمان مرکزی دانشگاه، طبقه ششم معاونت تحقیقات و فناوری
City - English: Tehran
City - Persian: تهران
Province: Tehran
Country: Iran (Islamic Republic of)
Postal code: ۱۴۱۹۷۳۳۱۴۱
Phone: +98 21 8163 3685
Fax:
Email: vcr@tums.ac.ir
Web page address: https://vcr.tums.ac.ir/
Name of organization / entity - English: Name of organization / entity - Persian: Full name of responsible person - English: Dr. Akbar Fatuhi Full name of responsible person - Persian: دکتر اکبر فتوحی Street address - English: Keshavarz Blvd., corner of Quds St., Central Organization of the University, 6th floor of Research and Technology Vice-Chancellor, Central Organization of the Tehran University, Keshavarz Blvd Street address - Persian: لواربلوار کشاورز، نبش خیابان قدس، سازمان مرکزی دانشگاه، طبقه ششم معاونت تحقیقات و فناوری City - English: Tehran City - Persian: تهران Province: Tehran Country: Iran (Islamic Republic of) Postal code: ۱۴۱۹۷۳۳۱۴۱ Phone: +98 21 8163 3685 Fax: Email: vcr@tums.ac.ir Web page address: https://vcr.tums.ac.ir/
Sharing plan
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ask for IPD through corresponding investigator
ask for IPD through corresponding investigator
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اطلاعات بیشتری وجود ندارد
اطلاعات بیشتری وجود ندارد
Access to the raw data of the study will be given
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Access to the raw data of the study will be given
دسترسی به داده های خام مطالعه داده خواهد شد
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دسترسی به داده های خام مطالعه داده خواهد شد
9 months after the completion of the project
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9 months after the completion of the project
9 ماه بعد از اتمام طرح
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9 ماه بعد از اتمام طرح
Researchers associated with academic centers
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Researchers associated with academic centers
محققین مرتبط با مراکز دانشگاهی
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محققین مرتبط با مراکز دانشگاهی
n case of sending an official request to the project manager
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n case of sending an official request to the project manager
در صورت ارسال درخواست رسمی به مجری طرح
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در صورت ارسال درخواست رسمی به مجری طرح
Mohammad Ayati Firozabadi
dr.mohammad.ayati@gmail.com
Orthopedic Department, Joint Reconstruction Research Center
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Mohammad Ayati Firozabadi dr.mohammad.ayati@gmail.com Orthopedic Department, Joint Reconstruction Research Center
مجری طرح:دکتر محمد آیتی فیروزآبادی
dr.mohammad.ayati@gmail.com
بخش ارتوپدی، مرکز تحقیقات بازسازی مفاصل
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مجری طرح:دکتر محمد آیتی فیروزآبادی dr.mohammad.ayati@gmail.com بخش ارتوپدی، مرکز تحقیقات بازسازی مفاصل
Sending official emails from related academic centers
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Sending official emails from related academic centers
ارسال ایمیل رسمی از مراکز مرتبط دانشگاهی
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ارسال ایمیل رسمی از مراکز مرتبط دانشگاهی
Protocol summary
Study aim
Comparing the effectiveness of intra-articular injection of morphine, ketorolac with and without injection
Tranexamic acid in reducing pain and short-term clinical outcome after arthroscopic reconstruction of anterior cruciate ligament in patients with exclusive injury of ACL
Design
A controlled, parallel-group, double-blind, randomized, phase 3 clinical trial on 100 patients. For randomization, the random numbers given to each of them by the computer enter the control group or the intervention group.
Settings and conduct
Patients in Imam Khomeini Hospital, Tehran, after meeting the entry criteria and obtaining informed consent, will be divided into 2 control and intervention groups, according to the sample size.
Participants/Inclusion and exclusion criteria
Individuals with exclusive rupture of the ACL in the age range of 15 to 60 years and weighing <100 kg who are able to read and write to give written informed consent and cooperate in the study were included.
And people with drug sensitivity or a history of drug dependence who have neurological and psychiatric problems, heart, kidney, liver disease and cardiac arrhythmia, diabetes, neuromuscular disease, inflammatory joint arthritis such as rheumatoid arthritis, or performing osteotomy surgery or the presence of accompanying cartilage damage or meniscal tear, They are being excluded from the study
Intervention groups
Intervention group:
30mg Ketorolac ampoule(1cc)
5mg morphine sulfate(0.5cc)
1gr Tranexamic acid (10cc)
100 mg of lidocaine (5 cc)
23.5cc of normal saline solution
Control group:
30mg Ketorolac ampoule(1cc)
5mg morphine sulfate(0.5cc)
100 mg of lidocaine (5 cc)
33.5cc of normal saline solution
Main outcome variables
Reducing the amount of pain and increasing the satisfaction and rehabilitation of patients after arthroscopic reconstruction of the ACL
General information
Reason for update
updating some of protocol fields
Acronym
IRCT registration information
IRCT registration number:IRCT20221230056983N1
Registration date:2023-02-25, 1401/12/06
Registration timing:registered_while_recruiting
Last update:2025-01-30, 1403/11/11
Update count:1
Registration date
2023-02-25, 1401/12/06
Registrant information
Name
Behzad Nezhadtabrizi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 6658 1653
Email address
tabrizibehzad@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-04-01, 1401/01/12
Expected recruitment end date
2023-10-31, 1402/08/09
Actual recruitment start date
2022-04-01, 1401/01/12
Actual recruitment end date
2023-10-31, 1402/08/09
Trial completion date
2024-01-29, 1402/11/09
Scientific title
The Comparison between intraarticular knee injection (Morphine, ketorolac) with and without Tranxamic acid following arthroscopic ACL reconstruction surgery in reducing pain and assessing functional outcomes in patient with isolated ACL injury
Public title
Investigating the effectiveness of intra-articular injection painkillers after cruciate ligament surgery
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
an isolated, unilateral, chronic ACL tear
Ability to read and write to give informed written consent and cooperate in the study
Use of hamstring autograft
American Society of Anesthesiologists (ASA) physical status of I
Exclusion criteria:
Drug sensitivity
multi-ligament injuries
bilateral ACL tears
acute ACL tears
bony deformities
a history of hematologic conditions or ischemic attacks
patients receiving anticoagulant therapy
Age
From 15 years old to 60 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Care provider
Investigator
Outcome assessor
Data analyser
Sample size
Target sample size:
100
Actual sample size reached:
100
Randomization (investigator's opinion)
Randomized
Randomization description
Table of random numbers (four block) by site randomization.com
Blinding (investigator's opinion)
Triple blinded
Blinding description
In our study, both the patients and the researchers are blinded to the prescription of the intervention drug, and the surgeon simply divides the patients into 2 groups, with and without the prescription of the drug, based on the argument of random numbers
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
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Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Tehran University of Medical Sciences
Street address
Joint Reconstruction Research Center, Orthopedic Department, Imam Khomeini Hospital Complex, Tohid Squre, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
۱۴۱۹۷۳۳۱۴۱
Approval date
2022-08-30, 1401/06/08
Ethics committee reference number
IR.TUMS.IKHC.REC.1401.134
Health conditions studied
1
Description of health condition studied
isolated anterior cruciate ligament injury
ICD-10 code
S83.5
ICD-10 code description
Sprain and strain involving (anterior)(posterior) cruciate ligament of knee
Primary outcomes
1
Description
pain variables including the amount of pain based on Visual Analogue Scale (VAS)
Timepoint
The pain level of the patients is based on the Visual Analoque Scale or VAS with a score from 1 to 10, which is measured in the intervals of one hour, two hours, 3 hours, 6 hours, 12 hours, one week, one month and three months after the operation.
Method of measurement
The level of patient satisfaction are measured based on the Visual Analogue Scale index
2
Description
Functional variables in patients including Knee Injury and Osteoarthritis Outcome Score (KOOS).
Timepoint
It is measured before surgery, one month and three months after surgery.
Method of measurement
The score of the KOOS or Knee injury and Osteoarthritis Outcome Score questionnaire examines the patient in 5 areas and its score is 0 to 100%.
Secondary outcomes
1
Description
Functional variables in patients including Lysholm
Timepoint
Lysholm questionnaire score from 0 to 100, before surgery, one hour, one month and three months after surgery.
Method of measurement
The performance of all patients is completed and evaluated based on the Lysholm questionnaire
Intervention groups
1
Description
Control group: Intra-articular injection of 40 cc of analgesic cocktail after surgery including: 30 mg Ketorolac ampoule (1 cc), 5 mg of morphine sulfate (0.5 cc),100 mg of lidocaine (5 cc), 33.5 cc of normal solution Saline; All made by Iranian pharmaceutical companies
Category
Treatment - Drugs
2
Description
Intervention group: Intra-articular injection of 40 cc of analgesic cocktail after surgery including: 30 mg Ketorolac ampoule (1 cc), 5 mg of morphine sulfate (0.5 cc), 1 gram of tranexamic acid (TXA) (10 cc)100 mg of lidocaine (5 cc) 23.5 cc normal saline solution; All made by Iranian pharmaceutical companies