Protocol summary

Study aim
The effect of combined block of lateral femoral cutaneous nerve and femoral nerve on thigh tourniquet pain during unilateral foot or ankle orthopedic surgery.
Design
A two-arm parallel, randomized controlled clinical trial with concealed blinded randomization sequence and blinded outcome assessment.
Settings and conduct
Sixty patients in Akhtar Hospital affiliated to Shahid Beheshti University of Medical Sciences are randomly enrolled into two equal groups after obtaining informed consent. When a satisfactory level of block is achieved, a thigh tourniquet is inflated in the proximal part of the thigh. The tourniquet pain is assessed by a blinded observer immediately after inflation and then every 5 min with a 5-point verbal rating scale (VRS). If the patient complains of pain or VRS was >1, bolus doses of intravenous fentanyl or ketamine are given alternatively.
Participants/Inclusion and exclusion criteria
AَُSA Ⅰ-Ⅱ patients are included. Patients with allergy to local anesthetics, coagulation disorders, opium addiction, infection at the block site, previous femoral or popliteal bypass surgery, BMI ≥ 30, sickle cell anemia, and lack of cooperation are excluded.
Intervention groups
In the Spinal group, 3 ml of 0.5% hyperbaric bupivacaine is injected intrathecally. In the Peripheral nerve block group, popliteal, femoral nerve (FN), and lateral femoral cutaneous nerve (LFCN) block is performed under the guidance of ultrasound. 20 ml of 1.5% lidocaine with epinephrine 1:200000 + bicarbonate is administered for popliteal block, 15 ml and 5 ml of the same solution for FN and LFCN, respectively. After 20 minutes, sensory block is assessed by the pinprick testing and the motor block by the modified Bromage scale by a blinded observer.
Main outcome variables
Intraoperative tourniquet pain; block performance time; surgical anesthetic effect time; total doses of intraoperative analgesics.

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20131108015322N3
Registration date: 2020-05-25, 1399/03/05
Registration timing: retrospective

Last update: 2020-05-25, 1399/03/05
Update count: 0
Registration date
2020-05-25, 1399/03/05
Registrant information
Name
Shideh Dabir
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 2243 2595
Email address
sdabir@sbmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-05-15, 1398/02/25
Expected recruitment end date
2020-03-15, 1398/12/25
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the effectiveness of combined sciatic –femoral nerve blocks together with lateral femoral cutaneous nerve block on thigh tourniquet pain with spinal anesthesia in foot and ankle orthopedic surgery patients
Public title
"Effect of combined sciatic –femoral nerve blocks and lateral femoral cutaneous nerve on thigh tourniquet pain in foot and ankle orthopedic surgery"
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
ASA class I,II Age 18-70 years Unilateral foot and ankle orthopedic surgery
Exclusion criteria:
ASA class≥ III Allergy to local anesthetics Coagulation disorders opium addiction Uncooperative patient Infection at nerve block site Vascular grafting of femoral or popliteal vessels BMI≥30 Sickle cell anemia Extensive and traumatic surgery of tibia and fibula Tourniquet inflation time less than 60 minutes Patient refusal
Age
From 18 years old to 70 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 50
Randomization (investigator's opinion)
Randomized
Randomization description
Participants are randomly assigned to 1 of 2 groups following simple randomization by using a random numbers table . The allocation sequence was concealed in sequentially numbered, opaque, sealed envelopes. After acceptance of the eligible patient and in the operating room, the numbered envelope is opened by an investigator with no clinical involvement in the trial. Randomization and assignment of patients is done by a person not involved in the study. The person who measures the outcome in two groups is also kept blinded.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Research Ethics Committee of Shahid Beheshti University of Medical Sciences
Street address
Building No. 2, 6th floor, Office of Research Affairs, Shahid Chamran Highway, Yemen St., Arabi St., next to Taleghani Hospital
City
Tehran
Province
Tehran
Postal code
1983963113
Approval date
2019-04-30, 1398/02/10
Ethics committee reference number
IR.SBMU.MSP.REC.1398.058

Health conditions studied

1

Description of health condition studied
Treatment of thigh tourniquet- related acute pain during lower limb surgery
ICD-10 code
ICD-10 code description

Primary outcomes

1

Description
Intraoperative severity of tourniquet pain
Timepoint
Immediately after tourniquet inflation, and then every 5 min until the end of surgery
Method of measurement
Tourniquet pain intensity is evaluated by using a 5-point verbal rating scale (VRS) (0 =no pain, 1= mild pain, 2=moderate pain, 3= severe pain, 4=unbearable pain).

Secondary outcomes

1

Description
Time taken to perform the block
Timepoint
The time taken from the beginning to the end of local anesthetic injection
Method of measurement
The interval ( minutes) between the beginning to the end of local anesthetic injection

2

Description
Anesthetic effect time
Timepoint
Time required from the end of local anesthetic injection to achieve adequate anesthesia
Method of measurement
The interval (minutes) between the end of local anesthetic injection and block success required for surgical anesthesia

3

Description
Intraoperative total doses of fentanyl and ketamin
Timepoint
During operation
Method of measurement
Boluses of intravenous fentanyl (µg) or ketamine (mg) given during surgery are recorded and for each drug, the total dose was calculated.

Intervention groups

1

Description
Control group: In the patients in the control group, the standard method of spinal anesthesia is performed in the lateral position. 3 ml of 0.5% hyperbaric bupivacaine is injected intrathecally using a 25G Quincke spinal needle. Then the patients are placed in the supine position.
Category
Treatment - Other

2

Description
Intervention group:In this group, blockade of popliteal, femoral nerve (FN), and lateral femoral cutaneous nerve (LFCN) block are performed under the guidance of ultrasound (SonoSite S-Nerve, Bothell, WA, USA) using a 6-13 MHz linear transducer and a 22G-bevel 30°, 85 mm block needle (Visioplex®, Vygon, Ecouen, France). In the lateral position, 20 ml of 1.5% lidocaine with epinephrine 1:200000 + bicarbonate is administered for popliteal block . 15 ml and 5 ml of the same solution is injected for block of the FN and LFCN, respectively in the supine position.
Category
Treatment - Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Akhtar Hospital
Full name of responsible person
Faramarz Mosaffa
Street address
Department of Anesthesiology, Akhtar Hospital, Shariati Ave., Pole- Rumi St., Sharifimanesh St., Azar dead end
City
Tehran
Province
Tehran
Postal code
1964714953
Phone
+98 21 2664 0307
Fax
+98 21 2664 0307
Email
faramarzmosaffa@yahoo.com
Web page address
http://amc.sbmu.ac.ir/#

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Afshin Zarghi, phD
Street address
Building No. 2, 5th floor, Office in Research Affairs, shahid Beheshti University of Medical sciences, Shahid Chamran Highway, Yemen St., Arabi St., next to Taleghani Hospital
City
Tehran
Province
Tehran
Postal code
1964714953
Phone
+98 21 2243 9781
Fax
+98 21 2243 9981
Email
Mpajouhesh@sbmu.ac.ir
Web page address
http://retech.sbmu.ac.ir/index.jsp?fkeyid=&siteid=24&pageid=2554
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahid Beheshti 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
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Shideh dabir
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Anesthesiology and Critical care Department, Taleghani Hospital, Arabi St., Yemen St., Velenjak
City
Tehran
Province
Tehran
Postal code
1985717413
Phone
+98 21 2243 2595
Email
shdabir@yahoo.com
Web page address
http://taleghani.sbmu.ac.ir/

Person responsible for scientific inquiries

Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Shideh Dabir
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Anesthesiology and Critical care Department, Taleghani Hospital, Arabi St., Yemen St., Velenjak
City
Tehran
Province
Tehran
Postal code
1985717413
Phone
+98 21 2243 2595
Email
shdabir@yahoo.com
Web page address
http://taleghani.sbmu.ac.ir/

Person responsible for updating data

Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Shideh Dabir
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Department of Anesthesiology, Taleghani Hospital, Aaraabi St., Yaman St., Velenjak
City
Tehran
Province
Tehran
Postal code
1985717413
Phone
+98 21 2243 2595
Fax
Email
sdabir@sbmu.ac.ir
Web page address
http://taleghani.sbmu.ac.ir/

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
Yes - There is a plan to make this available
Statistical Analysis Plan
Not applicable
Informed Consent Form
No - There is not a plan to make this available
Clinical Study Report
No - There is not a plan to make this available
Analytic Code
Not applicable
Data Dictionary
Not applicable
Title and more details about the data/document
Study Protocol: The whole research protocol are to be shared.
When the data will become available and for how long
There is no further information.
To whom data/document is available
There is no further information.
Under which criteria data/document could be used
There is no further information.
From where data/document is obtainable
There is no further information.
What processes are involved for a request to access data/document
There is no further information.
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