Protocol summary
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Study aim
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The aim of current study is to compare interscalene nerve block with suprascapular nerve block with axillary nerve block under ultrasound guidance for pain relief after arthroscopic sholder surgery
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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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Sixty patients with arthroscopic shoulder surgery were randomly divided into two equal groups and will undergo interscalene nerve block or suprascapular nerve block with axillary nerve block under ultrasound guidance for pain relief after surgery.
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Participants/Inclusion and exclusion criteria
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Inclusion criteria:
Age 18-60 years old
Patients with ASA I,II
Exclusion criteria:
Allergy to local anesthesia
Patients with liver disease
Alcohol and drug abuse
BMI>35
Diabetic neuropathy
Neurological disorders
Coagulation disorders
Psychopathy disorders
Inappropriate answer to questions
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Intervention groups
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First group : interscalene nerve block
Second group: suprascapular nerve block with axillary nerve block
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Main outcome variables
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Patient's pain will be evaluated 4, 8, 12 and 24 hours after surgery.
General information
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Reason for update
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We have reset the recruitment dates.
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Acronym
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IRCT registration information
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IRCT registration number:
IRCT20120814010599N23
Registration date:
2018-11-12, 1397/08/21
Registration timing:
prospective
Last update:
2020-05-03, 1399/02/14
Update count:
1
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Registration date
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2018-11-12, 1397/08/21
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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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2018-11-07, 1397/08/16
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Expected recruitment end date
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2019-07-05, 1398/04/14
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Actual recruitment start date
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2018-11-25, 1397/09/04
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Actual recruitment end date
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2019-08-10, 1398/05/19
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Trial completion date
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2019-09-10, 1398/06/19
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Scientific title
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A comparative study of interscalene block and supra scapular block with axillary nerve block, under ultrasound guidance to relieve pain after arthroscopic surgery of shoulder
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Public title
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Interscalene block and supra scapular block with axillary nerve block, under ultrasound guidance to relieve pain after arthroscopic surgery of shoulder
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Purpose
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Treatment
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Inclusion/Exclusion criteria
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Inclusion criteria:
Age 18-60 years old
Patients with ASA I,II
Exclusion criteria:
Allergy to local anesthesia
Patients with liver disease
Alcohol and drug abuse
BMI>35
Diabetin Neuropathy
Neurological disorders
Coagulation disorders
Psychological disorders
Inappropriate answer to questions
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Age
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From 18 years old to 60 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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Sample size
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Target sample size:
60
Actual sample size reached:
60
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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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2018-03-16, 1396/12/25
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Ethics committee reference number
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IR.IUMS.FMD.REC1396.9511174016
Health conditions studied
1
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Description of health condition studied
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Relieve pain after arthroscopic shoulder surgery
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ICD-10 code
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M 25.5
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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 arthroscopic shoulder surgery
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Timepoint
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4, 8, 12 and 24 hours after surgery
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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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Complications
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Timepoint
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During 24 hours after surgery
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Method of measurement
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With physical examination
Intervention groups
1
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Description
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Intervention group: First group will undergo interscalene nerve block under ultrasound guidance for pain relief after arthroscopic surgery
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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 suprascapular nerve block with axillary nerve block under ultrasound guidance for pain relief after arthroscopic surgery
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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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