Patients undergoing elective knee arthroscopy referring to Imam Reza Hospital are randomly assigned to two equal groups using randomized software. In one group, the femoral nerve block and obturator nerve block and in the other group of spinal anesthesia are performed for surgery. Patients will be evaluated in terms of pain intensity with the visual analog scale and the degree of satisfaction based on the scale of the VAS and the checklist prepared.(a study is one in which neither the nurse who is in charge of measuring the NRS nor the statistician know about used analgesia method)
Participants/Inclusion and exclusion criteria
Entry criteria: aged 18 to 50 years, classification of American Society of Anesthesiology (ASA1), lack of sensitivity to topical anesthetic drugs, BMI less than 30, patient satisfaction
Non-compliance criterion: having coagulation disorders, the presence of infection at the injection site, having nerve disorders at the foot of the site
Intervention groups
Femoral nerve block and obturator nerve block in the group and spinal anesthesia in the other group of patients
Main outcome variables
The amount and severity of postoperative pain, the patient's satisfaction from analgesia
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20181128041783N1
Registration date:2019-01-19, 1397/10/29
Registration timing:registered_while_recruiting
Last update:2019-01-19, 1397/10/29
Update count:0
Registration date
2019-01-19, 1397/10/29
Registrant information
Name
Mahsa Mahdavi siuki
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 51 3609 1639
Email address
mahdavism941@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-04-22, 1397/02/02
Expected recruitment end date
2019-03-13, 1397/12/22
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of Obturator nerve block and Femoral nerve block with spinal anesthesia for analgesia after elective knee arthroscopy
Public title
Comparison of Obturator nerve block and Femoral nerve block with spinal anesthesia for analgesia after elective knee arthroscopy
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Aged 18 to 50 years
Classification of American Society of Anesthesiology (ASA-1)
Non-sensitivity to local anesthetic drugs
BMI less than 30
patient satisfaction.
Exclusion criteria:
Having coagulation disorders
Infection in the injection site
Having nerve disorders at the foot of the site
Age
From 18 years old to 50 years old
Gender
Both
Phase
N/A
Groups that have been masked
Outcome assessor
Data analyser
Sample size
Target sample size:
72
Randomization (investigator's opinion)
Randomized
Randomization description
Random Software
Blinding (investigator's opinion)
Double blinded
Blinding description
This is a double-blind interventional study (a study is one in which neither the nurse who is in charge of measuring the NRS nor the statistisian know about used analgesia method), all patients in Imam Reza hospital that are candidates for knee arthroscopy can be enrolled in this study after signing the contest form.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Mashhad University of Medical Sciences
Street address
No170, 36th Jalal Al-e-Ahmad Blv,
City
Mashhad
Province
Razavi Khorasan
Postal code
9516133519
Approval date
2018-10-15, 1397/07/23
Ethics committee reference number
IR.MUMS.MEDICAL.REC.1397.145
Health conditions studied
1
Description of health condition studied
Comparison of obturator nerve block and femoral nerve block with spinal anesthesia in analgesia after elective knee arthroscopy
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Severity of pain after surgery
Timepoint
The severity of pain in the recovery at 3, 6, 12 and 24 hours after surgery
Method of measurement
Numeric pain rating scale
Secondary outcomes
empty
Intervention groups
1
Description
1 Intervention group: For the obturator nerve block, the patient's hip should be placed in the abduction and the external rotational position. The ultrasound probe will be placed in the medial segment of the inguinal groove. After detecting the pectinose muscle, the probe head spins 40 to 50 degrees towards the cranial to reveal the hyperecho structure in the posterolateral pectinose (the lower edge of the upper rhomus pubis).Then, in the fascia space between the two muscles of Abductor Longus and the Abductor Brevis anterior branches, and between the abductor brevis and Abdactor magnus, the posterior branch of the obturator nerve is characterized by ultrasound and a stimulator of the nerve with a 0.5mA and proper stimulation of the contraction of the abductor muscles. Linear probe with a frequency of 10 MHz is used for this purpose and the block is performed out of plane. In the vicinity of each anterior and posterior branches of the obturator nerve 5 cc lidocaine 2% with 0.5 cc bicarbonate and 25 micrograms of fentanyl and then 3 cc marcaine 0.5% with epinephrine 1/200000 is injected to increase block length. For the femoral block, after the preparation of the probe area, ultrasound is placed in the ligament of the inguinal lining. The lateral to the femoral artery and the sub facia Iliaka, the femoral nerve is targeted with the help of a nerve stimulus needle and in-plane ultrasound guidance. After a 0.5 mA quadriceps shrinkage, 10 cc lidocaine 2% with 1 cc bicarbonate and 50 micrograms fentanyl and then 6 cc marcaine 0.5% with epinephrine 1/200000 are injected to increase the block length.
Category
Other
2
Description
2 Intervention group: To perform the spinal anesthesia, the patient is placed in setting position. In L4-L5 space, in the midline, with needle number 25, the needle is perpendicular to the Dora axis, after inserting the needle into the subarachnoid space, the needle is 90 degrees Rotate counterclockwise and inject 15 mg of marcaine 0.5% with 25 μg of fentanyl. After the anesthesia, the surface of the block is checked with a pinprick test to ensure that the level of the block reaches l3, which is a suitable level for performing orthoscopy.
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Reza hospital
Full name of responsible person
Mahdavi Siuki Mahsa
Street address
Imam Reza hospital. Ebne sina Ave
City
Mashhad
Province
Razavi Khorasan
Postal code
9137913316
Phone
+98 51 3802 2713
Email
mahdavism941@mums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Mohsen Tafaghodi
Street address
Deputy of Research and Technology, Mashhad university of Medical sciences, Daneshgah Ave
City
Mashhad
Province
Razavi Khorasan
Postal code
9137913131
Phone
+98 51 3841 2081
Email
vcresearch@mums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?