Radial Artery CannulationNCT05459792
Comparative Study Between the Effect of Ultrasound Guided Median Nerve Block , Radial Nerve Block and Local Infiltration on Feasibility of Radial Artery Cannulation
A study testing median nerve block, radial nerve block and local infiltration in people with Radial Artery Cannulation, run by Kasr El Aini Hospital at 2 sites in Egypt.
Trial summary
Arterial line placement is often needed in various critical care settings. It is a basic procedure performed for continuous blood pressure (BP) monitoring and rapid access for repeated arterial blood gas samples, as it is considered to be more precise than measurement of BP by other noninvasive devices, especially in… Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Radial Artery Cannulation
- What is being tested?
- median nerve block, radial nerve block and local infiltration
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 126 participants
- Where
- 2 sitesEgypt
- Study dates
- 18 Jul 2022to Dec 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Gender both males and females
- ASA Class II
- Age 18-70 years
- Patients undergoing surgeries requiring radial arterial cannulation expected to be needed , and in place for the first 24 hours postoperatively as thoracic surgeries(e,g lobectomy, pneumonectomy),major vascular surgeries (carotid end arterctomy,abdominal aneurysm) , or major abdominal surgery .
Who cannot join
- Hypersensitivity or knownallergy to amide local anesthetics
- Pre-existing neurological deficit/peripheral neuropathy and Coagulation disorders.
- Local infection at the site of block and at the planned cannulation site.
- peripheral occlusive vascular disease, surgery for vascular injury or thromboembolic phenomena, cervical rib, and conditions associated with obstruction to arterial or venous flow.
- Emergency operations and occlusion of the ipsilateral ulnar artery
- patients on vasopressors and radial artery cannula removal before 24 hours postoperative.
Trial locations and contacts
2 sites in 1 country.
Egypt2 sites, 2 recruiting
- Recruiting
Kasr Al Ainy
Cairo, 202
- Recruiting
Kasr Alainy, Cairo University
Cairo, 202
Ahmed nabih, lecturer, 01002773488 ext. 202, nabihomar100@yahoo.com
mohamed abdel ghany, lecturer, 01016109777, dr.mohamed.elshazly8686@gmail.com
About this study
Official title: Comparative Study Between the Effect of Ultrasound Guided Median Nerve Block , Radial Nerve Block and Local Infiltration on Feasibility of Radial Artery Cannulation in Patients Undergoing Major Surgeries. A Randomized Control Study
Arterial line placement is often needed in various critical care settings. It is a basic procedure performed for continuous blood pressure (BP) monitoring and rapid access for repeated arterial blood gas samples, as it is considered to be more precise than measurement of BP by other noninvasive devices, especially in the critically ill patients or those on continuous infusions of vasoactive drugs.Arterial line placement is presumed to be a relatively safe procedure, with a rate of major complications that is below 1%. The most common site of cannulation is the radial artery, primarily due to the ease of access owing to the superficial nature of the vessel and the ease with which the site can be maintained. Additional advantages of radial artery cannulation include anatomical reliability and the less complications. However placement of a radial artery catheter can, at times, be difficult because many patients who emergently need a catheter may have a weak arterial pulse due to dehydration or blood loss or may have some form of peripheral vascular disease. Although it is usually a well-tolerated procedure, it is considered more painful than intravenous (i.v.) cannula placement, particularly in case of multiple attempts of cannulation
In this study the investigators will assess the effect of ultrasound guided median nerve block, radial nerve block and local infiltration with lidocaine on feasibility of radial artery cannulation in patients undergoing major surgeries
Read more
Objectives
- To evaluate the effect of ultrasound guided median nerve block, radial nerve block and local infiltration on feasibility of radial artery cannulation
- To determine the effect of ultrasound guided median nerve block, radial nerve block and local infiltration in reducing discomfort and complicationassociated with radial arterial cannulation .
- To evaluate the effect of ultrasound guided median nerve block, radial nerve block and local infiltration in radial artery diameter and blood flow for radial arterial cannulation
Read the detailed description
This a randomized control trial is designed to include (126) patients ASA physical status II patients ranging from(18) to(70)years old scheduled for elective surgery who required arterial cannulation prior to the induction of general anesthesia.
Patients meeting the inclusion criteria will be randomly assigned to receive either :
Group I :median nerve block technique (n=42) GroupII: radial nerve block technique:(n=42) Group III:local infiltrationtechnique(n=42)
Anesthesia management After arrival to the anaesthetic room, An 18-gauge intravenous cannula will be placed at the forearm on the opposite arm, standard monitoring will be used (non-invasive arterial blood pressure, ECG, pulse oximetry) Parameters like heart rate and mean blood pressure will be recorded at baseline and after 15 min of the block. Premedication will be given intravenously in the form of 0.03 mg/kg midazolam The patient will be in a supine position with the operative arm abducted to 90 and supported on an arm board .
An ultrasound device with a high-frequency linear array probe( siemens acuson x 300 ultrasound with 8-14 MHz) will be used for the measurement of the transverse diameter and peak velocity of the radial artery. The high frequency probe will be kept transeversaly on the radial artery, 1 cm proximal to the radial styloid process.The diameter of the radial artery will be measured as the horizontal distance between the 2 inner walls of the artery using the electronic calliper in the US machine,Transverse diameters will be measured by M-mode ultrasound, and the M mode sample line will always be adjusted to pass through the center of vessels to measure the diameters more precisely. All peak velocities will be measured using the pulsed-wave Doppler ultrasound mode. The Doppler sampling volume will be placed in the center of the blood vessel, and the width of the sampling range gate is 2 mm. Doppler angle correction will be performed when measuring velocity, with the calibration main line parallel to the direction of blood flow and at an angle of 50-60°.this measurment will be noted at baseline and 5 min after successful block or local infilitration, every 30 minutes intraoperative, and every 4 hours for the first 24 hours or till radial cannula is removed which ever is sooner.
Nerve blocks:
the various nerves will be visualised and blocked using 22 G 50 mm insulated nerve Sonoplex needle. All blocks will be given by one researcher using 5 ml 0.25% bupivacaine with 1% lidocaine for each nerve block after negative aspiration for blood so as to cover the nerve circumferentially The various locations of the nerve blocks will be:
- Radial nerve: in the forearm: at the elbow (the radial nerve between the brachioradialis and the biceps muscle). the preferred approach is to start proximally above the elbow and identify the radial nerve as a triangular hyperechoic structure coming off the distal humerus. then following this distally to the antecubital fossa, where the nerve will branch into its superficial and deep branches . the needle will be introduced in-plane view from lateral to medial aimed at the fascial plane adjacent to the radial nerve.
- Median nerve: Mid forearm (between the superficial and deep compartment) A linear transducer will be placed on the ventral aspect of the mid-forearm, where the median nerve is visible in the fascial plane between the flexor digitorum superficialis and flexor digitorum profundus after raising a skin wheal using local anesthetic, the needle will be introduced in-plane view from lateral to medial and aimed at the fascial plane adjacent to the median nerve. local infiltration: Patients in this group received an intradermal infiltration followed by a subcutaneous injection with a total of 3 mL of 0.25% bupivacaine with1% lidocaine with a27- G needle.
Sensory blockade of the median, radial nerves will be graded according to the previously validated 3point scale using a cold test: respectively: 0 = no perception, 1 = decreased sensation, or 2 = normal sensation. it will be measured every 5 min . Blocks will be assumed to be successful if there is absence of sensation to ice (sensory block score = 0) If complete sensory blockade will not be achieved within 30 minutes, the affected subject will be excluded from the study and categorized as a block failure.
The operator will reassess the radial pulse and will grade the change in palpability of radial pulse from 0 to 4 as follows:
Grade 0 : radial pulse not palpable after the injection. Grade 1 : radial pulse become feeble after the injection Grade 2: palpability of radial pulse remains the same after the injection Grade 3: radial pulse become better palpable after the injection Grade 4 : radial pulse become bounding after the injection
Arterial cannulation will be intended to be performed after varification of successful blocks or local infiltiration, the arm will be abducted at an angle of 70 to 90 and the wrist will be hyper extended to facilitate palpation and cannulation of the radial artery. After identification of the optimal site for cannulation of the radial artery, the overlying skin will be disinfected with a swab impregnated with an alcohol- based skin disinfectant solution.
An arterial line will be then placed in the usual fashion using a standard Arrow kit, which will conclude the subject's participation in this study. The start time will be defined as the initial needle penetration through the skin. The time to successful arterial cannulation will be measured as removal of the metal needle and continuation of a flash of arterial blood. Failure to cannulate will be quantified as numbers of needle tips completely withdrawn from the skin . The success rate will be defined as successful cannulation of the radial artery in 3 attempts or fewer.
Patients will be asked to rate their discomfort using a number from 0 meaning no discomfort to 10 meaning strongest imaginable discomfort." In case of an unsuccessful cannulation or a failure cannulation will be started at an alternative site. Further cannulation attempts at an alternative site will not be assessed.
Post cannulation complication will be recorded such as arterial spasm, ischemia, thrombosis and hematoma formation.
Measurement tools
- Patients demographic data will be collected; age, gender, weight, type of surgery and duration of surgery.
- The ultrasound measurements (The peak velocity (mm/s)and transverse diameter(mm) values of radial artery at base line , 5 min after successful blocks or local infilitration, every 30 minutes intra operative, and every 4 hours for the first 24 hours or till radial cannula is removed which ever is sooner.
3 -Parameters like heart rate and mean blood pressure will be recorded at baseline and 5 min after successful blocks or local infilitration, every 30 minutes intraoperative.
4- feasability of cannulation: defined as number of attempts of cannulation, and time taken in seconds till successful cannulation.
5- Incidence of post cannulation complication such as arterial spasm , ischemia ,thrombosis and hematoma formation in the first 24 hours postoperative.
6- The degree of palpability of radial pulse
- Conditions
- Radial Artery Cannulation
- Being tested
- median nerve block, radial nerve block, local infiltration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
median nerve blockProcedure or surgery
Also called peripheral nerve block
It will be given by one researcher using 5 ml 0.25% bupivacaine with 1% lidocaine for each nerve block after negative aspiration for blood so as to cover the nerve circumferentially
radial nerve blockProcedure or surgery
Also called peripheral nerve block
It will be given by one researcher using 5 ml 0.25% bupivacaine with 1% lidocaine for each nerve block after negative aspiration for blood so as to cover the nerve circumferentially
local infiltrationProcedure or surgery
Also called bupivacaine and lidocaine infiltration
intradermal infiltration followed by a subcutaneous injection with a total of 3 mL of 0.25% bupivacaine with1% lidocaine with a27- G needle
| Study group | Role | What they receive |
|---|---|---|
| ultrasound guided median nerve block | Experimental | A linear transducer will be placed on the ventral aspect of the mid-forearm, where the median nerve is visible in the fascial plane between the flexor digitorum superficialis and flexor digitorum profundus after raising a skin wheal using local anesthetic, the needle will be introduced in-plane view from lateral to medial and aimed at the fascial plane adjacent to the median nerve. Receives: Procedure: median nerve block |
| ultrasound guided radial nerve block | Experimental | A linear transducer will be placed on the forearm: at the elbow (the radial nerve between the brachioradialis and the biceps muscle). the preferred approach is to start proximally above the elbow and identify the radial nerve as a triangular hyperechoic structure coming off the distal humerus. then following this distally to the antecubital fossa, where the nerve will branch into its superficial and deep branches. the needle will be introduced in-plane view from lateral to medial aimed at the fascial plane adjacent to the radial nerve. Receives: Procedure: radial nerve block |
| local infiltration | Placebo comparator | Intradermal infiltration followed by a subcutaneous injection with a total of 3 mL of 0.25% bupivacaine with1% lidocaine with a27- G needle. Receives: Procedure: local infiltration |
What is being measured
The primary outcome is the main question the study is designed to answer.
The time to successful radial arterial cannulation
It is measured from the initial needle penetration through the skin to removal of the metal needle and continuation of a flash of arterial blood in seconds
Measured: It will be measured from the initial needle penetration through the skin to removal of the metal needle and continuation of a flash of arterial blood in seconds at base line (15 minutes )before surgery
Secondary outcomes (1)
Incidence of post cannulation complication such as arterial spasm , ischemia ,thrombosis and hematoma formation in the first 24 hours postoperative
arterial spasm , ischemia ,thrombosis and hematoma formation
Measured: It will be measured in the first 24 hours postoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jul 2022
- Study start18 Jul 2022
- Primary completionDec 2022 (estimated)
- Study completionDec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Radial Artery CannulationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 126 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kasr El Aini Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmed nabih youssef, Kasr El Aini Hospital
- Investigators
- Amr ahmed abdel kader, lecturer, Study director, Anesthesia department , Cairo university
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05459792
- Sponsor's protocol ID
- N-52-2022
- Status last verified
- Jul 2022
- First submitted
- 12 Jul 2022
- Last updated
- 20 Jul 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Study Between the Effect of Ultrasound Guided Median Nerve Block , Radial Nerve Block and Local Infiltration on Feasibility of Radial Artery Cannulation in Patients Undergoing Major Surgeries. A Randomized Control Study
- ClinicalTrials.gov ID
- NCT05459792
- Acronym / sponsor ID
- N-52-2022
- Conditions
- Radial Artery Cannulation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 126 participants (estimated)
- Lead sponsor
- Kasr El Aini HospitalUniversity, hospital or other
- Study start
- 18 Jul 2022 (actual)
- Primary completion
- Dec 2022 (estimated)
- Study completion
- Dec 2022 (estimated)
- First posted
- 15 Jul 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Arterial line placement is often needed in various critical care settings. It is a basic procedure performed for continuous blood pressure (BP) monitoring and rapid access for repeated arterial blood gas samples, as it is considered to be more precise than measurement of BP by other noninvasive devices, especially in the critically ill patients or those on continuous infusions of vasoactive drugs.Arterial line placement is presumed to be a relatively safe procedure, with a rate of major complications that is below 1%. The most common site of cannulation is the radial artery, primarily due to the ease of access owing to the superficial nature of the vessel and the ease with which the site can be maintained. Additional advantages of radial artery cannulation include anatomical reliability and the less complications. However placement of a radial artery catheter can, at times, be difficult because many patients who emergently need a catheter may have a weak arterial pulse due to dehydration or blood loss or may have some form of peripheral vascular disease. Although it is usually a well-tolerated procedure, it is considered more painful than intravenous (i.v.) cannula placement, particularly in case of multiple attempts of cannulation
In this study the investigators will assess the effect of ultrasound guided median nerve block, radial nerve block and local infiltration with lidocaine on feasibility of radial artery cannulation in patients undergoing major surgeries
Objectives
- To evaluate the effect of ultrasound guided median nerve block, radial nerve block and local infiltration on feasibility of radial artery cannulation
- To determine the effect of ultrasound guided median nerve block, radial nerve block and local infiltration in reducing discomfort and complicationassociated with radial arterial cannulation .
- To evaluate the effect of ultrasound guided median nerve block, radial nerve block and local infiltration in radial artery diameter and blood flow for radial arterial cannulation
Detailed description
This a randomized control trial is designed to include (126) patients ASA physical status II patients ranging from(18) to(70)years old scheduled for elective surgery who required arterial cannulation prior to the induction of general anesthesia.
Patients meeting the inclusion criteria will be randomly assigned to receive either :
Group I :median nerve block technique (n=42) GroupII: radial nerve block technique:(n=42) Group III:local infiltrationtechnique(n=42)
Anesthesia management After arrival to the anaesthetic room, An 18-gauge intravenous cannula will be placed at the forearm on the opposite arm, standard monitoring will be used (non-invasive arterial blood pressure, ECG, pulse oximetry) Parameters like heart rate and mean blood pressure will be recorded at baseline and after 15 min of the block. Premedication will be given intravenously in the form of 0.03 mg/kg midazolam The patient will be in a supine position with the operative arm abducted to 90 and supported on an arm board .
An ultrasound device with a high-frequency linear array probe( siemens acuson x 300 ultrasound with 8-14 MHz) will be used for the measurement of the transverse diameter and peak velocity of the radial artery. The high frequency probe will be kept transeversaly on the radial artery, 1 cm proximal to the radial styloid process.The diameter of the radial artery will be measured as the horizontal distance between the 2 inner walls of the artery using the electronic calliper in the US machine,Transverse diameters will be measured by M-mode ultrasound, and the M mode sample line will always be adjusted to pass through the center of vessels to measure the diameters more precisely. All peak velocities will be measured using the pulsed-wave Doppler ultrasound mode. The Doppler sampling volume will be placed in the center of the blood vessel, and the width of the sampling range gate is 2 mm. Doppler angle correction will be performed when measuring velocity, with the calibration main line parallel to the direction of blood flow and at an angle of 50-60°.this measurment will be noted at baseline and 5 min after successful block or local infilitration, every 30 minutes intraoperative, and every 4 hours for the first 24 hours or till radial cannula is removed which ever is sooner.
Nerve blocks:
the various nerves will be visualised and blocked using 22 G 50 mm insulated nerve Sonoplex needle. All blocks will be given by one researcher using 5 ml 0.25% bupivacaine with 1% lidocaine for each nerve block after negative aspiration for blood so as to cover the nerve circumferentially The various locations of the nerve blocks will be:
- Radial nerve: in the forearm: at the elbow (the radial nerve between the brachioradialis and the biceps muscle). the preferred approach is to start proximally above the elbow and identify the radial nerve as a triangular hyperechoic structure coming off the distal humerus. then following this distally to the antecubital fossa, where the nerve will branch into its superficial and deep branches . the needle will be introduced in-plane view from lateral to medial aimed at the fascial plane adjacent to the radial nerve.
- Median nerve: Mid forearm (between the superficial and deep compartment) A linear transducer will be placed on the ventral aspect of the mid-forearm, where the median nerve is visible in the fascial plane between the flexor digitorum superficialis and flexor digitorum profundus after raising a skin wheal using local anesthetic, the needle will be introduced in-plane view from lateral to medial and aimed at the fascial plane adjacent to the median nerve. local infiltration: Patients in this group received an intradermal infiltration followed by a subcutaneous injection with a total of 3 mL of 0.25% bupivacaine with1% lidocaine with a27- G needle.
Sensory blockade of the median, radial nerves will be graded according to the previously validated 3point scale using a cold test: respectively: 0 = no perception, 1 = decreased sensation, or 2 = normal sensation. it will be measured every 5 min . Blocks will be assumed to be successful if there is absence of sensation to ice (sensory block score = 0) If complete sensory blockade will not be achieved within 30 minutes, the affected subject will be excluded from the study and categorized as a block failure.
The operator will reassess the radial pulse and will grade the change in palpability of radial pulse from 0 to 4 as follows:
Grade 0 : radial pulse not palpable after the injection. Grade 1 : radial pulse become feeble after the injection Grade 2: palpability of radial pulse remains the same after the injection Grade 3: radial pulse become better palpable after the injection Grade 4 : radial pulse become bounding after the injection
Arterial cannulation will be intended to be performed after varification of successful blocks or local infiltiration, the arm will be abducted at an angle of 70 to 90 and the wrist will be hyper extended to facilitate palpation and cannulation of the radial artery. After identification of the optimal site for cannulation of the radial artery, the overlying skin will be disinfected with a swab impregnated with an alcohol- based skin disinfectant solution.
An arterial line will be then placed in the usual fashion using a standard Arrow kit, which will conclude the subject's participation in this study. The start time will be defined as the initial needle penetration through the skin. The time to successful arterial cannulation will be measured as removal of the metal needle and continuation of a flash of arterial blood. Failure to cannulate will be quantified as numbers of needle tips completely withdrawn from the skin . The success rate will be defined as successful cannulation of the radial artery in 3 attempts or fewer.
Patients will be asked to rate their discomfort using a number from 0 meaning no discomfort to 10 meaning strongest imaginable discomfort." In case of an unsuccessful cannulation or a failure cannulation will be started at an alternative site. Further cannulation attempts at an alternative site will not be assessed.
Post cannulation complication will be recorded such as arterial spasm, ischemia, thrombosis and hematoma formation.
Measurement tools
- Patients demographic data will be collected; age, gender, weight, type of surgery and duration of surgery.
- The ultrasound measurements (The peak velocity (mm/s)and transverse diameter(mm) values of radial artery at base line , 5 min after successful blocks or local infilitration, every 30 minutes intra operative, and every 4 hours for the first 24 hours or till radial cannula is removed which ever is sooner.
3 -Parameters like heart rate and mean blood pressure will be recorded at baseline and 5 min after successful blocks or local infilitration, every 30 minutes intraoperative.
4- feasability of cannulation: defined as number of attempts of cannulation, and time taken in seconds till successful cannulation.
5- Incidence of post cannulation complication such as arterial spasm , ischemia ,thrombosis and hematoma formation in the first 24 hours postoperative.
6- The degree of palpability of radial pulse
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| ultrasound guided median nerve block | Experimental | Procedure: median nerve blockA linear transducer will be placed on the ventral aspect of the mid-forearm, where the median nerve is visible in the fascial plane between the flexor digitorum superficialis and flexor digitorum profundus after raising a skin wheal using local anesthetic, the needle will be introduced in-plane view from lateral to medial and aimed at the fascial plane adjacent to the median nerve. |
| ultrasound guided radial nerve block | Experimental | Procedure: radial nerve blockA linear transducer will be placed on the forearm: at the elbow (the radial nerve between the brachioradialis and the biceps muscle). the preferred approach is to start proximally above the elbow and identify the radial nerve as a triangular hyperechoic structure coming off the distal humerus. then following this distally to the antecubital fossa, where the nerve will branch into its superficial and deep branches. the needle will be introduced in-plane view from lateral to medial aimed at the fascial plane adjacent to the radial nerve. |
| local infiltration | Placebo comparator | Procedure: local infiltrationIntradermal infiltration followed by a subcutaneous injection with a total of 3 mL of 0.25% bupivacaine with1% lidocaine with a27- G needle. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Gender both males and females
- ASA Class II
- Age 18-70 years
- Patients undergoing surgeries requiring radial arterial cannulation expected to be needed , and in place for the first 24 hours postoperatively as thoracic surgeries(e,g lobectomy, pneumonectomy),major vascular surgeries (carotid end arterctomy,abdominal aneurysm) , or major abdominal surgery .
Key exclusion criteria (6 listed)
- Hypersensitivity or knownallergy to amide local anesthetics
- Pre-existing neurological deficit/peripheral neuropathy and Coagulation disorders.
- Local infection at the site of block and at the planned cannulation site.
- peripheral occlusive vascular disease, surgery for vascular injury or thromboembolic phenomena, cervical rib, and conditions associated with obstruction to arterial or venous flow.
- Emergency operations and occlusion of the ipsilateral ulnar artery
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| median nerve blockAlso: peripheral nerve blockIt will be given by one researcher using 5 ml 0.25% bupivacaine with 1% lidocaine for each nerve block after negative aspiration for blood so as to cover the nerve circumferentially | Procedure or surgery | ultrasound guided median nerve block |
| radial nerve blockAlso: peripheral nerve blockIt will be given by one researcher using 5 ml 0.25% bupivacaine with 1% lidocaine for each nerve block after negative aspiration for blood so as to cover the nerve circumferentially | Procedure or surgery | ultrasound guided radial nerve block |
| local infiltrationAlso: bupivacaine and lidocaine infiltrationintradermal infiltration followed by a subcutaneous injection with a total of 3 mL of 0.25% bupivacaine with1% lidocaine with a27- G needle | Procedure or surgery | local infiltration |
Primary outcome
The time to successful radial arterial cannulation
Time frame: It will be measured from the initial needle penetration through the skin to removal of the metal needle and continuation of a flash of arterial blood in seconds at base line (15 minutes )before surgery
It is measured from the initial needle penetration through the skin to removal of the metal needle and continuation of a flash of arterial blood in seconds
1 secondary outcome
Incidence of post cannulation complication such as arterial spasm , ischemia ,thrombosis and hematoma formation in the first 24 hours postoperative
Time frame: It will be measured in the first 24 hours postoperative
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jul 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Amr ahmed abdel kader, lecturer study director
Anesthesia department , Cairo university
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing median nerve block, radial nerve block and local infiltration in people with Radial Artery Cannulation, run by Kasr El Aini Hospital at 2 sites in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 20 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ahmed nabih, lecturer (01002773488 ext. 202, nabihomar100@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The time to successful radial arterial cannulation (time frame: It will be measured from the initial needle penetration through the skin to removal of the metal needle and continuation of a flash of arterial blood in seconds at base line (15 minutes )before surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Jul 2022.