Femoral nerve block at the adductor canal entrance interventional performance and compare it with the classical method for analgesia after knee surgery in patients who have elective knee surgery
1- The Goals:
1-1- The main goals:
1-1-1- Determine the efficiency of ultrasound- assisted femoral nerve block at the adductor canal analgesia after elective knee surgery.
1-1-2- Determine the efficiency of ultrasound- assised femoral nerve block at inguinal canal for analgesia after elective knee surgery.
1-2-The subsidiary goals:
1-2-1- Determine the VAS pain scale after femoral nerve block in patients with adductor canal and compare them with the classic method.
1-2-2- Determine the immobilization of the knee after femoral nerve block at the adductor canal for analgesia after surgery and compare them with classic method.
1-2-3- Determine the satisfaction of each methods and compare them.
2- Designing:
Patients seeking elective knee surgery were randomly assigned to two groups are.
For postoperative analgesia after surgery for a knee blocks is done through the classical method,and the second block on the knee adductor canal is done by comparing the results of analgesia in both groups.
3- Methods:
Patients are randomized to two groups,in one group after surgery Femoral block for inguinal region with the help of ultrasound twenty cc of local anesthetic,under name classic method.
in the second group,after surgery femoral nerve block with ultrasound of the adductor canal,with ten cc local anesthetic.
Patients remained under observation for 24h and follow up the presence and intensity of pain.
4- Participants:
Patients undergoing elective surgery like arthroscopy.
The inclusion main criteria: patients without disease of uncontrolled entrance; the absence of coagulopathy; the absence of addiction; the absence of neuropathy; age 15-70 y; body mass index less than 35; elective knee surgery.
The exclusion main criteria: discontent of patients; complications related to the block.
5- Interventions: Femoral nerve block using both classical and adductor canal methods.
6- The main variable and outcome: Analgesia and immobilization.
General information
Acronym
-
IRCT registration information
IRCT registration number:IRCT2014111219924N1
Registration date:2015-01-07, 1393/10/17
Registration timing:retrospective
Last update:
Update count:0
Registration date
2015-01-07, 1393/10/17
Registrant information
Name
Armaghan Abbasi Baharanchi
Name of organization / entity
Iran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 936 687 9814
Email address
feiz.hr@iums.ac.ir
Recruitment status
Recruitment complete
Funding source
Investigator
Expected recruitment start date
2012-01-21, 1390/11/01
Expected recruitment end date
2014-01-21, 1392/11/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Femoral nerve block at the adductor canal entrance interventional performance and compare it with the classical method for analgesia after knee surgery in patients who have elective knee surgery
Public title
Comparison of two types of block for analgesia after knee surgery
Purpose
Supportive
Inclusion/Exclusion criteria
The inclusion main criteria:
The absence af coagulopathy;
ASA 1-2;
Elective knee surgery;
Age 15-70 y;
The absence of opium addiction;
The absence of neuropathy;
BMI less than 35.
The exclusion main criteria:
Lack of consent;
Creates block side effects.
Age
From 15 years old to 70 years old
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
96
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
1
Registry name
-
Secondary trial Id
-
Registration date
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Iran University of Medical Sciences Ethics Committee
Street address
Iran University of Medical Sciences Ethics Committee, Iran University of Medical Sciences, Between Chamran and Sheikh Fazlullah, Hemmat highway, Tehran
City
Tehran
Postal code
-
Approval date
2014-07-21, 1393/04/30
Ethics committee reference number
93 –d– 105 - 1964
Health conditions studied
1
Description of health condition studied
Local anesthesia
ICD-10 code
Y48.3
ICD-10 code description
Local anaesthetics
Primary outcomes
1
Description
Analgesia after femoral block or Obturator block
Timepoint
Immediately after blocking and 3, 6, 12 and 24 hours later
Method of measurement
Questionnaire and Examination of patient
Secondary outcomes
1
Description
Immobility after femoral block or Obturator block
Timepoint
Immediately after blocking and 3, 6, 12 and 24 hours later
Method of measurement
Questionnaire and Examination of patient
Intervention groups
1
Description
Intervention conducted in the intervention group:
Femoral nerve block via adductor canal with the aid of ultrasounography,
Once injection,Marcaine 0.125% 10 cc.
Category
Treatment - Drugs
2
Description
Intervention conducted In control group:
Femoral nerve block in inguinal canal with the aid of ultrasounography,
Once injection. Marcaine 0.125% 20 cc.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Hazrat Rasoul Akram Hospital in Tehran
Full name of responsible person
Armaghan Abbasi Baharanchi
Street address
Hazrat Rasoul Akram Hospital, Niayesh St., Sattarkhan Ave., Tehran
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research, Iran University of Medical Sciences
Full name of responsible person
Doctor Morteza Naserbakht
Street address
5th floor, Central Office, Iran University of Medical Sciences, Between Chamran and Sheikh Fazlullah, Hemmat highway, Tehran
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellor for research, Iran University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Armaghan Abbasi Baharanchi
Position
Anesthesia Resident
Other areas of specialty/work
Street address
Hazrat Rasoul Akram Hospital, Niayesh St., Sattarkhan Ave., Tehran
City
Tehran
Postal code
-
Phone
+98 936 687 9814
Fax
Email
abbasi.arm8@gmail.com; sh_abbasi23@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Armaghan Abbasi Baharanchi
Position
Anesthesia Resident
Other areas of specialty/work
Street address
Hazrat Rasoul Akram Hospital, Niayesh St., Sattarkhan Ave., Tehran
City
Tehran
Postal code
Phone
+98 936 687 9814
Fax
Email
abbasi.arm8@gmail.com; sh_abbasi23@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Armaghan Abbasi Baharanchi
Position
Anesthesia Resident
Other areas of specialty/work
Street address
Hazrat Rasoul Akram Hospital, Niayesh St., Sattarkhan Ave., Tehran
City
Tehran
Postal code
Phone
+98 936 687 9814
Fax
Email
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)