Protocol summary

Study aim
To determine the effectiveness of fascia iliaca block on thigh tourniquet pain during unilateral below-knee orthopedic surgeries
Design
A two-arm parallel, randomized controlled clinical trial with concealed randomization sequence and blinded outcome assessment.
Settings and conduct
72 patients are recruited from Akhtar hospital affiliated to Shahid Beheshti University of Medical Sciences after obtaining informed consent. They are randomly divided into two equal groups of spinal anesthesia and fascia iliaca block by a blinded investigator. When a satisfactory block is achieved, a pneumatic thigh tourniquet is inflated in the proximal part of the thigh. The tourniquet pain is assessed by a blinded observer immediately after tourniquet inflation and then every 5 min until the end of surgery with a 5-point verbal rating scale (VRS). If the patient complains of pain or VRS >1, bolus doses of intravenous fentanyl or ketamine are given alternatively. If inadequate, general anesthesia is performed.
Participants/Inclusion and exclusion criteria
Inclusion criteria: AَُSA 1 or 2 patients, aged 14 to 80 years, scheduled for unilateral below-knee orthopedic surgery using a pneumatic thigh tourniquet. Exclusion criteria: Patients with allergy to local anesthetics, coagulation disorders, opium addiction, infection at the block site, previous femoral or popliteal bypass surgery, BMI more than 30, sickle cell anemia, tourniquet inflation time less than 60 minutes, and lack of cooperation.
Intervention groups
In the patients in the control group, the standard method of spinal anesthesia is performed. In the Intervention group, fascia iliaca and popliteal blockades are performed under the guidance of ultrasound
Main outcome variables
Severity of tourniquet pain during surgery; time to perform the block; anesthetic effect time; total doses of analgesics given intraoperatively.

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20131108015322N4
Registration date: 2020-07-25, 1399/05/04
Registration timing: retrospective

Last update: 2020-07-25, 1399/05/04
Update count: 0
Registration date
2020-07-25, 1399/05/04
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
2019-05-12, 1398/02/22
Expected recruitment end date
2020-03-16, 1398/12/26
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the effectiveness of fascia iliaca block plus popliteal block on thigh tourniquet pain in below- knee orthopedic surgery compared with spinal anesthesia
Public title
Effect of fascia iliaca block on thigh tourniquet pain in orthopedic surgery
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
ASA class1 and 2 unilateral surgery
Exclusion criteria:
Allergy to local anesthetics Age> 80 yrs Coagulation disorders Opium addiction Infection at the block site Previous femoral or popliteal bypass surgery BMI ≥30 Sickle cell anemia Tourniquet inflation time less than 60 minutes Uncooperative patients
Age
From 14 years old to 80 years old
Gender
Both
Phase
N/A
Groups that have been masked
  • Investigator
  • Outcome assessor
  • Data analyser
Sample size
Target sample size: 72
Randomization (investigator's opinion)
Randomized
Randomization description
We used a simple random sampling method using a table of random numbers to generate a random sequence of patients. even numbers were considered for the peripheral nerve block group and odd numbers for the spinal anesthesia group. The researcher then touches one of the numbers in the table of random numbers and moves in the right direction of the table, recording the numbers and assigning them to two groups. Each random sequence is recorded on a card. When the eligible participants enter the study, the cards are selected in order of their sequence.
Blinding (investigator's opinion)
Single blinded
Blinding description
Randomization, assignment of patients in each group, and random selection of envelopes is done by an investigator with no involvement in the trial. The person who measures the outcomes is also kept blinded.
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, Shahid Beheshti University of Medical Sciences
City
Tehran
Province
Tehran
Postal code
1985717443
Approval date
2019-03-17, 1397/12/26
Ethics committee reference number
IR.Sbmu.Retech.Rec.1397.1370

Health conditions studied

1

Description of health condition studied
management of acute tourniquet pain during below-knee surgery
ICD-10 code
ICD-10 code description

Primary outcomes

1

Description
The severity of tourniquet pain during surgery
Timepoint
Immediately after tourniquet inflation, and then every 5 min until the end of surgery
Method of measurement
Using a 5-point verbal rating scale (VRS) consisting of; 0 =no pain, 1= mild pain, 2=moderate pain, 3= severe pain, 4=unbearable pain.

Secondary outcomes

1

Description
Block performance time
Timepoint
The time taken from the beginning to the end of the local anesthetic injection
Method of measurement
The interval between the beginning to the end of local anesthetic injection in minutes.

2

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

3

Description
The total doses of fentanyl and ketamine administered.
Timepoint
During surgery
Method of measurement
Intravenous boluses of fentanyl (µg) or ketamine (mg) given during surgery are recorded and the total dose given for each drug is calculated.

Intervention groups

1

Description
Control group: In the patients in the control group, the method of spinal anesthesia is performed. In these patients, 15 mg of 0.5% hyperbaric bupivacaine is injected intrathecally using a 25G Quincke spinal needle.
Category
Treatment - Other

2

Description
Intervention group: In this group, fascia iliaca and popliteal blockades are performed under the guidance of ultrasound (SonoSite S-Nerve, Bothell, WA, USA) using a 6-13 MHz linear transducer. For the popliteal block, 20 ml of lidocaine 1.5% + epinephrine 1:200000 is administered. For fascia iliaca block, 30 ml of the same solution is injected just below the fascia iliaca.
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
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
1985717443
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
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/

Sharing plan

Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
There is no further information
Study Protocol
Undecided - It is not yet known if there will be 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
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
No - There is not a plan to make this available
Data Dictionary
No - There is not a plan to make this available
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