Comparison between ultrasound guided periarterial femor block and femoral nerve block on intraoperative hypertensionduring tourniquet closure in anterior cruciate ligament surgery under general anesthesia: a double-blind randomized clinical trial
Comparison between ultrasound guided periarterial femor block and femoral nerve block on intraoperative hypertension
during tourniquet closure in ACL surgery under general anesthesia
Design
The study has two intervention groups, which are divided into two groups of 25 based on the sample size formula and previous studies. Patients are randomly assigned to two groups on the sealdenvelope website, and the study is conducted in a double-blind manner.
Settings and conduct
Study location: Study is performed in general operation room of Rasool hospital Tehran-Iran;
Study population: Patients between 18-75 years old who have ACL knee surgery;
Type of study: The study is double blinded , patient and observer don't aware of type of intervention.
Participants/Inclusion and exclusion criteria
Inclusion criteria:
oral and written consent;
bَeing at the age of 18-75 years old;
ACL surgery;
Weight more than 50 kg.
exclusion criteria:
Patient diagnosed with chronic pain;
Opium addiction;
pregnancy;
local infection.
Intervention groups
In our study we have two intervention groups .All patients are having ACL surgery under general anesthesia. First intervention group will have periarterial femoral block under ultrasound guidance with rupivacaine . Second intervention group will have classic femoral nerve block under ultrasound guidance with rupivacaine.
Main outcome variables
Pain during surgery , Post operation pain, Anesthesia depth,
arterial blood pressure before inflating tourniquet and after deflating tourniquet, arterial blood pressure during tourniquet inflation
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20220904055873N1
Registration date:2022-10-10, 1401/07/18
Registration timing:prospective
Last update:2022-10-10, 1401/07/18
Update count:0
Registration date
2022-10-10, 1401/07/18
Registrant information
Name
Arezoo Hosseinkhani
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 2273 6391
Email address
parham_c11@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-11-06, 1401/08/15
Expected recruitment end date
2023-08-23, 1402/06/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison between ultrasound guided periarterial femor block and femoral nerve block on intraoperative hypertensionduring tourniquet closure in anterior cruciate ligament surgery under general anesthesia: a double-blind randomized clinical trial
Public title
Comparison between ultrasound guided periarterial femor block and femoral nerve block effects in anterior cruciate ligament surgery under general anesthesia
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
oral and written consent
Being at the age of 18-75 years old
ACL surgery
Weight more than 50kg
Exclusion criteria:
Patient diagnosed with chronic pain
Opium addiction or other drugs
pregnancy
local infection
Allergy to local anesthetic
weight less than 50 or BMI more than 30
Coagulopathy
Patient unable to evaluate pain score
Chronic uncontrolled disease
Blood loss more than 500 cc during surgery
Surgery duration longer than 3 hours
Age
From 18 years old to 75 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Care provider
Outcome assessor
Data analyser
Sample size
Target sample size:
50
Randomization (investigator's opinion)
Randomized
Randomization description
For randomization we use block randomization method.we put patients in two groups and use www.sealedenvelope.com website for making sequence.In each block we have 5 cases. We use A for group who are having periarterial femoral block and use B for the second group (classic femoral block). Then we have A and B sequences in 10 blocks for 50 cases which will be divided into two groups containing 25 cases.At last we put cards with the blocks written on them in envelopes. by this method allocation concealment is done.
Blinding (investigator's opinion)
Double blinded
Blinding description
The observer and patient dosen't know type of the block.The procedure is done when the patient put under general anesthesia. The patient and the person who observe the patient are unaware of block type.
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
ran University of Medical Sciences; Hemmat highway
City
Tehran
Province
Tehran
Postal code
149614535
Approval date
2022-04-23, 1401/02/03
Ethics committee reference number
IR.IUMS.FMD.REC.1401.078
Health conditions studied
1
Description of health condition studied
Knee surgery
ICD-10 code
ICD-10 code description
2
Description of health condition studied
ACL surgery
ICD-10 code
ICD-10 code description
3
Description of health condition studied
Femoral block
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Pain during surgery
Timepoint
During surgery
Method of measurement
ANI (anlgesia nociception index)
2
Description
post operation pain
Timepoint
after surgery
Method of measurement
Visual Analogue Scale (VAS)
3
Description
Mean arterial blood pressure before inflating tourniquet and after deflating
Timepoint
10 minutes interval 3 times
Method of measurement
arterial line
4
Description
Mean arterial blood pressure after inflating of tourniquet
Timepoint
Every 15 minutes till the end of surgery
Method of measurement
Arterial line
5
Description
Anesthesia depth
Timepoint
Every 30 minutes till the end of general surgery
Method of measurement
Bispectral index(BIS)
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Periarterial femoral block for patients between 18 to 75 years who are having ACL surgery under general anesthesia. Patients in each group are routinely anesthetized(with Propofol,Fentanyl , Midazoalm and Cisatracrium according to patient weight) . First group are having Periarterial femoral block under ultrasound guidance with 15cc rupivacaine 0.5% then needed data is observed during and after general anesthesia.
Category
Treatment - Drugs
2
Description
Intervention group: femoral block for patients between 18 to 75 years who are having ACL surgery under general anesthesia.Patients in each group are routinely anesthetized(with Propofol,Fentanyl , Midazoalm and Cisatracrium according to patient weight) . First group are having calssic femoral nerve block under ultrasound guidance with 15cc rupivacaine 0.5% then needed data is observed during and after general anesthesia.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Rasool Akram hospital
Full name of responsible person
Arezoo Hosseinkhani
Street address
Rasool Akram hospital, Mansoori st., Niyayesh st., Sattarkhan st.
City
Tehran
Province
Tehran
Postal code
1445613131
Phone
+98 21 6435 1000
Email
rasoolhospital@iums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Hossein Keyvani
Street address
Iran University of Medical Sciences, Near Milad tower, Hemmat highway, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1449614535
Phone
+98 21 86701
Email
adminsite@iums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?