Clinical Trial Details
— Status: Recruiting
Administrative data
| NCT number |
NCT05459792 |
| Other study ID # |
N-52-2022 |
| Secondary ID |
|
| Status |
Recruiting |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
July 18, 2022 |
| Est. completion date |
December 2022 |
Study information
| Verified date |
July 2022 |
| Source |
Kasr El Aini Hospital |
| Contact |
Ahmed nabih, lecturer |
| Phone |
01002773488 |
| Email |
nabihomar100[@]yahoo.com |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical 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 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
1. To evaluate the effect of ultrasound guided median nerve block, radial nerve block and
local infiltration on feasibility of radial artery cannulation
2. 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 .
3. 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
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:
1. 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.
2. 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
1. Patients demographic data will be collected; age, gender, weight, type of surgery and
duration of surgery.
2. 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
