Magnetic Resonance Imaging of Interscalene Plexus Block
Condition: Disorder of Shoulder
Study type: Interventional
Phase: Phase 4

Summary: 
      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.
    

Detailed description: 
      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).
    

Intervention name(s): Interscalene Nerve Block; Ropivacaine 0.75%, 20ml; Gadopentetate-Dimeglumine 0.0125 mmol; Gadopentetate-Dimeglumine 0.05 mmol; Ropivacaine 0.75%, 5ml; Shoulder Surgery
Intervention type(s): Procedure; Drug; Drug; Drug; Drug; Procedure
Intervention description(s): ultrasound guided interscalene plexus block (UISB) immediately before magnetic resonance imaging of the neck.; 20 ml of ropivacaine 0.75%; 0.0125 mmol of gadopentetate-dimeglumine; 0.05 mmol of gadopentetate-dimeglumine; 5 ml of ropivacaine 0.75%; As per individual requirement (patient-dependent)
Other intervention name(s): Naropin; Magnevist; Magnevist; Naropin
Intervention MeSH terms: Ropivacaine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Shoulder surgery