Protocol summary
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Study aim
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The aim of current study is to compare femoral nerve block with infrapatellar nerve block under ultrasound guidance in relieving pain; after elective arthroscopic surgery for reconstruction of anterior cruciate ligament
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Design
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Clinical trial study, with two parallel groups, double blinded, randomized
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Settings and conduct
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Ninety two patients with arthroscopic shoulder surgery were randomly divided into two equal groups and will undergo femoral nerve block or infrapatellar nerve block under ultrasound guidance in relieving pain; after elective arthroscopic surgery for reconstruction of anterior cruciate ligament
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Participants/Inclusion and exclusion criteria
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Inclusion criteria: age 20-40 years old; ASA I,II.
Exclusion criteria: coagulation disorders; injection site infection; neurological disorders and any neuropathy at the surgery site foot; allergy to local anesthesia; drug addiction; BMI>35.
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Intervention groups
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First group: femoral nerve block.
Second group: infrapatellar nerve block
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Main outcome variables
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Patient's pain will be evaluated 1, 3, 6, 12 and 24 hours after nerve block.
General information
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Reason for update
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The dates of completion of the patient recruitment were corrected and the correct form of the ethic code was entered. The ethic code is now available in the following URL.
http://ethics.research.ac.ir/PortalProposalList.php?code=IR.IUMS.FMD.REC.1398.377&title=&name=&stat=&isAll=&GlobalBackPage=http%3A%2F%2Fethics.research.ac.ir%2F
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Acronym
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IRCT registration information
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IRCT registration number:
IRCT20120814010599N22
Registration date:
2018-10-26, 1397/08/04
Registration timing:
prospective
Last update:
2020-02-01, 1398/11/12
Update count:
2
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Registration date
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2018-10-26, 1397/08/04
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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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2019-12-08, 1398/09/17
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Expected recruitment end date
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2020-04-02, 1399/01/14
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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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Comparative study of femoral nerve block with infrapatellar nerve block under ultrasound guidance in relieving pain; after elective arthroscopic surgery for reconstruction of anterior cruciate ligament
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Public title
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Femoral nerve block and infrapatellar nerve block under ultrasound guidance in relieving pain; after elective arthroscopic surgery for reconstruction of anterior cruciate ligament
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Purpose
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Treatment
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Inclusion/Exclusion criteria
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Inclusion criteria:
Age 20-40 years old
Patients with ASA I,II
Exclusion criteria:
Coagulation disorders
Injection sit infection
Neurological disorders and any neuropathy at the surgery site foot
Allergy to local anesthesia
Drug addiction
BMI>35
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Age
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From 20 years old to 40 years old
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Gender
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Both
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Phase
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N/A
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Groups that have been masked
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- Participant
- Outcome assessor
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Sample size
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Target sample size:
92
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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The patients are randomly divided by using a computer-generated random number list. The subjects are assigned into different groups by random allocation. Allocation concealment is obtained by maintaining the randomization list by study statistician.
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Blinding (investigator's opinion)
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Double blinded
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Blinding description
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The participant and person evaluating the outcome will be blinded to the allocated group.
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Placebo
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Not 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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2019-12-01, 1398/09/10
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Ethics committee reference number
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IR.IUMS.FMD.REC.1398.377
Health conditions studied
1
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Description of health condition studied
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Pain relieve after elective arthroscopic surgery for reconstruction of anterior cruciate ligament
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ICD-10 code
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M25.5
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ICD-10 code description
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Pain in joint
Primary outcomes
1
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Description
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Pain after elective arthroscopic surgery for reconstruction of anterior cruciate ligament
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Timepoint
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1, 3, 6,12 and 24 hours after nerve block
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Method of measurement
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Using Visual Analogue Scale scale
Secondary outcomes
1
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Description
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Patient's relaxation after nerve block
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Timepoint
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1, 3, 6, 12 and 24 hours after nerve block
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Method of measurement
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Using Ramsay scale
2
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Description
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Total dose of the opioid consumed via the pump
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Timepoint
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During 24 hours after nerve block
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Method of measurement
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Using questionnaire information
Intervention groups
1
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Description
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Intervention group: First group will undergo femoral nerve block under ultrasound guidance after elective arthroscopic surgery for reconstruction of anterior cruciate ligament.
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Category
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Treatment - Drugs
2
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Description
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Intervention group: Second group will undergo infrapatellar nerve block under ultrasound guidance after elective arthroscopic surgery for reconstruction of anterior cruciate ligament
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Category
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Treatment - Drugs
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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Iran 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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Undecided - It is not yet known if there will be a plan to make this available
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Study Protocol
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Undecided - It is not yet known if there will be a plan to make this available
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Statistical Analysis Plan
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Undecided - It is not yet known if there will be a plan to make this available
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Informed Consent Form
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Undecided - It is not yet known if there will be 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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Undecided - It is not yet known if there will be 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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We have not yet set a conclusion
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When the data will become available and for how long
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We have not yet set a conclusion
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To whom data/document is available
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We have not yet set a conclusion
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Under which criteria data/document could be used
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We have not yet set a conclusion
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From where data/document is obtainable
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We have not yet set a conclusion
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What processes are involved for a request to access data/document
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We have not yet set a conclusion
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Comments
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