Clinical Trial Details
— Status: Not yet recruiting
Administrative data
NCT number |
NCT06180941 |
Other study ID # |
brachial plexus block. |
Secondary ID |
|
Status |
Not yet recruiting |
Phase |
N/A
|
First received |
|
Last updated |
|
Start date |
December 2023 |
Est. completion date |
July 2024 |
Study information
Verified date |
December 2023 |
Source |
Assiut University |
Contact |
n/a |
Is FDA regulated |
No |
Health authority |
|
Study type |
Interventional
|
Clinical Trial Summary
Among paediatrics aging 3:12 who are going to have upper limb surgery,does adding clonidine
to bupivacaine improve brachial plexus block outcome in comparison with magnesium sulfate
with bupivacaine?
Description:
In upper extremity surgery, brachial plexus blocks are often preferred due to their
advantages, such as long postoperative analgesic efficacy and shortening the length of
hospital stay. This application reduces the use of opioids for postoperative analgesia and
provides protection from their side effects. However, procedure failure, nerve injury and
intravascular injection are the most common complications in the past years. In recent years,
performing ultrasound-guided blocks has increased the success of the procedure and decreased
the complication rate. Low number of studies, knowledge and experience in paediatric patients
led to worries that complications will be more common and caused less use of regional
techniques. However, good visualization of the anatomy in ultrasound-guided blocks and
successful results in adult patients brought up the application of ultrasound-guided brachial
plexus blocks in children.
Effective postoperative analgesia improves patient's outcome in terms of early ambulation,
decreased complications, and reduced incidence of postoperative chronic pain. Regional
anaesthetics is a safe and effective method for upper limb surgeries. This method can prolong
analgesia and reduce postoperative pain. Nowadays, peripheral nerve block has found an
important role in anaesthesiology. Safety and high success rate have made it a common
technique in outpatient and inpatient anaesthetics. Upper limb surgeries are mostly performed
under peripheral nerve blocks such as brachial plexus block. Brachial plexus may be blocked
in the level above the clavicle as interscalene and supraclavicular blocks or below the
clavicle as infraclavicular and axillary blocks. Supraclavicular brachial plexus block is
used for surgeries of the upper limb below the arm, from elbow to hand. Brachial plexus is
blocked in the level between trunks and divisions. In this level, a small volume of local
anaesthetic is needed for reliable block. The guide of ultrasound allows the
anaesthesiologist to see the subclavian artery as a bold marker and neural structures around
it above the 1st rib Regional anaesthetics may be one of the best solutions for
intraoperative and postoperative paediatric pain management; Supraclavicular brachial plexus
block is considered as one of the most effective anaesthetic methods for upper extremity
surgeries. Its major drawback, especially in children, is the risk of pneumothorax, vascular
puncture, and failure of the procedure due to inaccurate placement of the needle.
Ultrasound-guided needle placement may reduce the risk of complications and increase the
accuracy of block, particularly in paediatric patients. According to the surgeon's preference
and due to the need for a tourniquet at the proximal part of the humerus in all surgeries
regardless of the type of surgery, we considered supraclavicular block to be more suitable
than more distal ones. This block can be done with only one injection around the plexus and
provides sufficient anaesthetics at the tourniquet site as well.
Lignocaine and bupivacaine are the commonly used local anaesthetics in Brachial plexus
blocks. Lidocaine is an aminoamide, moderate acting local anaesthetic that blocks the
peripheral afferents acting on voltage-dependent sodium channels, Bupivacaine is a potent
local anaesthetic with unique characteristics from the amide group of local anaesthetics,
which was first discovered in 1957 and widely used for prolonged local and regional
anaesthetics.
To increase the duration of local anaesthetic effect in the supraclavicular block,Local
anaesthetics provide good anaesthetics in regional blocks, but have shorter duration of
postoperative analgesia. Thereby, various adjuncts like opioids, clonidine, neostigmine,
dexamethasone, alpha-2 agonists, dexmedetomidine, ketorolac, ketamine, and low-level laser
therapy, have been used in regional blocks to achieve desirable analgesia.
In the meantime, epinephrine is mostly used. Although epinephrine reduces the absorption of
local anaesthetics, reduces their toxicity, and prolongs anaesthetic duration, it can cause
hypertension and tachycardia. Therefore, its usage is limited when the patients have
cardiovascular disease or hyperthyroidism Magnesium sulphate is an N-methyl D-aspartate
(NMDA) receptor antagonist in the central nervous system (CNS) and peripheral nervous system
(PNS). The NMDA receptor complex contains binding sites for antagonists such as magnesium.
Magnesium is used as an adjuvant in peripheral nerve block. Anti-nociceptive effects of
magnesium are due to the regulation of calcium influx into the cell and antagonism of the
NMDA receptors. Many clinical studies have demonstrated that magnesium used during general
anaesthetics reduced anaesthetic requirement and postoperative rescue analgesic. Magnesium
has been commonly used as an antihypertensive agent. Magnesium may prevent postoperative
shivering. More recently, it has been shown that magnesium sulfate decreased the effects of
aminoamide local anaesthetics on rat sciatic nerves in vivo.
Recently, alpha-2 receptor-stimulating drugs due to excellent sedative effects, analgesia,
and anaesthetics with hemodynamic stability have been considered These pharmacologic
properties have been employed clinically to achieve the desired effects in regional
anaesthetics.
Clonidine, an a2 adrenergic agonist has sedative, analgesic, perioperative sympatholytic with
cardiovascular stabilizing effects and has been tried in combination with local anaesthetic
drugs to enhance regional anaesthetics.