Disorder of Shoulder Clinical Trial
Official title:
Magnetic Resonance Imaging of Local Anesthetic Distribution: A Comparison of 5 and 15 Milliliters of Ropivacaine 0,75% for Ultrasound Guided Interscalene Plexus Blockade
Interscalene plexus block is a widely used technique to provide anesthesia and analgesia for
surgery at the upper extremity (shoulder and upper arm); it is standard-of-care in many
institutions worldwide. Local anesthetic is being injected around the nerves supplying the
arm (Plexus brachialis) at a specific location in the arm (between the scalenus muscles,
thus called "interscalene plexus block"). The optimal volume of injection with regard to
efficacy, safety and avoidance of untoward effects has been subject to intense debate for a
long time. In spite of evidence that small volumes (between 5 and 7 mls) are effective for
adequate postoperative analgesia, larger volumes up to 40 mls are still frequently used in
many practices. However, with the use of such large doses, adverse events are known to occur
with increased frequency, including paralysis of the diaphragm or spread of local anesthetic
to the spinal cord.
This study is intended to help evaluate the effects of small or larger injection of local
anesthetic around the brachial plexus, and to correlate the distribution with clinical
efficacy, block duration, and possible side effects. It is a randomized, controlled,
observer-blinded trial; patients undergoing shoulder or upper arm surgery will be randomly
allocated to receive either 5mls or 20mls of local anesthetic for their interscalene plexus
block. Magnetic resonance imaging will be performed immediately afterwards, followed by a
series of neurological exams during the hospital stay. Test of lung function (spirometry)
and ultrasound of the diaphragm will be used to evaluate effects of the block on respiratory
mechanics.
Background: Interscalene plexus blockade (ISB) is frequently used during surgery of the
upper limb. The use of ultrasound has significantly reduced time of onset and total volume
of local anesthetics in comparison to nerve localization by stimulators. (1-4) The
introduction of this technique has been correlated with decreased volumes of effective local
anesthetics from 40 milliliters and more down to 10 milliliters and less.(3-4) As the
injection site of ISB is located in close proximity to the anatomical structures of the
spinal cord, spread of local anesthetics could potentially cause adverse events, including
contralateral blockade and total spinal anesthesia. Case reports on these complications have
been published previously. (5-11)In a recently published study we showed that the phenomenon
of epidural spread can be reproduced in cadavers and seems to be positively correlated to
injection-volumes exceeding 10 milliliters.(12) Moreover, we observed a trend towards
cranial spread of the contrast agent in all investigated specimens along the course of the
nerval roots towards the spinal cord. In another cadaveric study by Orebauch et al., cranial
epidural spread was also detectable following injection of dye into the nerval roots of the
brachial plexus.(13) Magnetic resonance imaging has not yet been used for visualization of
the spread of local anaesthetics in ISB.
Given that ultrasound provides excellent visualization of target-structures in regional
anesthesia and therefore enables physicians to place injection needles with enormous
accuracy, the question arises whether there is a critical volume for local anesthetics
increasing complications such as epidural spread and in consequence contralateral blockade.
The aim of this study is to confirm the findings of our cadaveric study in vivo and to show
that the frequency of epidural spread correlates with injection of increased volumes of
local anesthetics.
Primary endpoint: Spread of local anesthetics to the epidural space
Secondary endpoints:
- Contralateral epidural spread.
- Spread of local anesthetics to the phrenic nerve.
- Bed side spirometry and ultrasound investigation of the diaphragm in the PACU.
- Oxygen saturation in the PACU
- Self-reported block duration.
- Self reported pain scores for the first 24 postoperative hours
- Time to first analgesic consumption on demand.
- Total analgesic consumption (ropivacaine PCA).
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
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