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
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
Design
Clinical trial study, with two parallel groups, double blinded, randomized
Settings and conduct
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
Participants/Inclusion and exclusion criteria
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.
Intervention groups
First group: femoral nerve block.
Second group: infrapatellar nerve block
Main outcome variables
Patient's pain will be evaluated 1, 3, 6, 12 and 24 hours after nerve block.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20120814010599N22
Registration date:2018-10-26, 1397/08/04
Registration timing:retrospective
Last update:2018-10-26, 1397/08/04
Update count:2
Registration date
2018-10-26, 1397/08/04
Registrant information
Name
Poupak Rahimzadeh
Name of organization / entity
Iran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 6650 9059
Email address
p-rahimzadeh@tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2017-10-12, 1396/07/20
Expected recruitment end date
2018-08-11, 1397/05/20
Actual recruitment start date
2017-10-23, 1396/08/01
Actual recruitment end date
2018-09-19, 1397/06/28
Trial completion date
2018-09-24, 1397/07/02
Scientific title
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
Public title
Femoral nerve block and infrapatellar nerve block under ultrasound guidance in relieving pain; after elective arthroscopic surgery for reconstruction of anterior cruciate ligament
Purpose
Treatment
Inclusion/Exclusion criteria
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
Age
From 20 years old to 40 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Outcome assessor
Sample size
Target sample size:
92
Actual sample size reached:
92
Randomization (investigator's opinion)
Randomized
Randomization description
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.
Blinding (investigator's opinion)
Double blinded
Blinding description
The participant and person evaluating the outcome will be blinded to the allocated group.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of IRAN University of Medical Sciences
Street address
Iran University of Medical Sciences., next to Milad Tower., Hemmat Highway
City
Tehran
Province
Tehran
Postal code
1449614535
Approval date
2018-06-23, 1397/04/02
Ethics committee reference number
IR.IUMS.FMD.REC 1396.9511174013
Health conditions studied
1
Description of health condition studied
Pain relieve after elective arthroscopic surgery for reconstruction of anterior cruciate ligament
ICD-10 code
M25.5
ICD-10 code description
Pain in joint
Primary outcomes
1
Description
Pain after elective arthroscopic surgery for reconstruction of anterior cruciate ligament
Timepoint
1, 3, 6,12 and 24 hours after nerve block
Method of measurement
Using Visual Analogue Scale scale
Secondary outcomes
1
Description
Patient's relaxation after nerve block
Timepoint
1, 3, 6, 12 and 24 hours after nerve block
Method of measurement
Using Ramsay scale
2
Description
Total dose of the opioid consumed via the pump
Timepoint
During 24 hours after nerve block
Method of measurement
Using questionnaire information
Intervention groups
1
Description
Intervention group: First group will undergo femoral nerve block under ultrasound guidance after elective arthroscopic surgery for reconstruction of anterior cruciate ligament.
Category
Treatment - Drugs
2
Description
Intervention group: Second group will undergo infrapatellar nerve block under ultrasound guidance after elective arthroscopic surgery for reconstruction of anterior cruciate ligament
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Rasool Akram Hospital
Full name of responsible person
Poupak Rahim Zadeh
Street address
Department of pain، 4th Floor, Hazrat-E-Rasool Hospital, Iran University of Medical Sciences, Niayesh “St.”,Sattarkahn “Ave.”, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1445613131
Phone
+98 21 6651 5001
Email
P-Rahimzadeh@tums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Vice-Chancellor of research, IRAN University of Medical Sciences
Street address
Iran University of Medical Sciences., next to Milad Tower., Hemat Highway
City
Tehran
Province
Tehran
Postal code
1449614535
Phone
+98 21 8163 3685
Email
PR@iums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Iran 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
Iran University of Medical Sciences
Full name of responsible person
Poupak Rahimzadeh
Position
Associate professor
Latest degree
Subspecialist
Other areas of specialty/work
Anesthesiology
Street address
Hazrat Rasul Medical complex, Sattar khan Ave.
City
Tehran
Province
Tehran
Postal code
1916737183
Phone
+98 21 6435 2326
Fax
Email
p-rahimzadeh@tums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Poupak Rahimzadeh
Position
Associate professor
Latest degree
Subspecialist
Other areas of specialty/work
Anesthesiology
Street address
Hazrat Rasul Medical complex, Sattar khan Ave.
City
Tehran
Province
Tehran
Postal code
1916737183
Phone
+98 21 6435 2326
Fax
+98 21 6650 9059
Email
p-rahimzadeh@tums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Poupak Rahimzadeh
Position
Associate professor
Latest degree
Subspecialist
Other areas of specialty/work
Anesthesiology
Street address
Hazrat Rasul Medical complex, Sattar khan Ave.
City
Tehran
Province
Tehran
Postal code
1916737183
Phone
+98 21 6435 2326
Fax
+98 21 6650 9059
Email
p-rahimzadeh@tums.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Not applicable
Title and more details about the data/document
We have not yet set a conclusion
When the data will become available and for how long
We have not yet set a conclusion
To whom data/document is available
We have not yet set a conclusion
Under which criteria data/document could be used
We have not yet set a conclusion
From where data/document is obtainable
We have not yet set a conclusion
What processes are involved for a request to access data/document