Protocol summary
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Study aim
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Reduction of pain and hospitalization of patients undergoing knee arthroscopy by intra-articular injection of remifentanil
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Design
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The present study is a double-blind that Phase of clinical trial is phase 2-3 with 60 patients undergoing meniscus knee arthroscopy.
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Settings and conduct
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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.
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Participants/Inclusion and exclusion criteria
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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
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Intervention groups
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Intervention group: intra-articular injection of Remifentanil will be done.
Control group: placebo intra-articular injection will be done.
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Main outcome variables
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Pain
General information
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Reason for update
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Primary version has some errors and was not complete
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Acronym
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IRCT registration information
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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
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Registration date
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2020-01-04, 1398/10/14
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Registrant information
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Recruitment status
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Recruitment complete
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Funding source
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Expected recruitment start date
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2019-04-11, 1398/01/22
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Expected recruitment end date
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2020-04-11, 1399/01/23
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Actual recruitment start date
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empty
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Actual recruitment end date
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empty
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Trial completion date
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empty
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Scientific title
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Effect of Remifentanil on Postoperative Pain in Knee Arthroscopic Surgery; a Randomized Controlled Clinical Trial
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Public title
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Effect of Remifentanil on Postoperative Pain in Knee Arthroscopic Surgery
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Purpose
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Prevention
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Inclusion/Exclusion criteria
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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
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Age
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No age limit
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Gender
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Both
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Phase
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2-3
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Groups that have been masked
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- Participant
- Care provider
- Investigator
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Sample size
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Target sample size:
60
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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Computer generated randomization, using www.randomization.com
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Blinding (investigator's opinion)
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Double blinded
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Blinding description
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Patients and the person who injects the drug do not aware of the type of drug.
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Placebo
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Used
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Assignment
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Parallel
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Other design features
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Ethics committees
1
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Ethics committee
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Approval date
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2019-07-09, 1398/04/18
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Ethics committee reference number
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IR.MUMS.MEDICAL.REC.1398.614
Health conditions studied
1
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Description of health condition studied
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Knee Meniscus Injury
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ICD-10 code
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S83.7
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ICD-10 code description
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Injury to multiple structures of knee
Primary outcomes
1
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Description
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Pain
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Timepoint
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After surgery
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Method of measurement
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Visual Analogue Scale
Intervention groups
1
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Description
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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.
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Category
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Prevention
2
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Description
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Control group: 25 cc of normal saline intra-articular will be injected at the end of surgery.
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Category
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Prevention
1
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Sponsor
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Grant name
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Grant code / Reference number
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Is the source of funding the same sponsor organization/entity?
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Yes
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Title of funding source
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Mashhad University of Medical Sciences
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Proportion provided by this source
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100
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Public or private sector
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Public
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Domestic or foreign origin
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Domestic
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Category of foreign source of funding
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empty
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Country of origin
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Type of organization providing the funding
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Academic
Sharing plan
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Deidentified Individual Participant Data Set (IPD)
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Yes - There is a plan to make this available
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Study Protocol
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Yes - There is a plan to make this available
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Statistical Analysis Plan
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Yes - There is a plan to make this available
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Informed Consent Form
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Yes - There is a plan to make this available
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Clinical Study Report
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Yes - There is a plan to make this available
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Analytic Code
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Yes - There is a plan to make this available
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Data Dictionary
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Not applicable
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Title and more details about the data/document
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As a research paper
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When the data will become available and for how long
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2020
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To whom data/document is available
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researchers
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Under which criteria data/document could be used
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medical students
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From where data/document is obtainable
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sent an email
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What processes are involved for a request to access data/document
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sent an email
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Comments
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