Ultrasound-Guided Erector Spinae Plane Block or Interscalen Brachial Plexus Block Following Arthroscopic Shoulder Surgery
Condition: Shoulder Syndrome
Study type: Interventional

Summary: 
      Postoperative pain is important following arthroscopic shoulder surgery. Postoperative
      effective pain treatment provides early mobilization and shorter hospital stay.Ultrasound
      (US)-guided brachial plexus blocks such as interscalen and supraclavicular block are usually
      performed. Interscalen brachial plexus block (ISCB) is one of the most preferred techniques
      among these.

      The US-guided erector spina plane block (ESPB) is a novel interfacial plan block defined by
      Forero et al. Local anesthetic injection is administrated into the deep fascia of erector
      spinae. ESPB provides thoracic analgesia at T5 level, abdominal analgesia at T7-9 level, and
      lumbar analgesia at T10-12, L3 levels. There are a few case reports about the efficacy of
      ESPB for acute and chronic shoulder pain. However, there are no randomized clinical studies.
      The aim of this study is to compare the efficacy of the US-guided ESPB and ISCB for
      postoperative analgesia management after arthroscopic shoulder surgery.
    

Detailed description: 
      Postoperative pain is an important issue in patients underwent arthroscopic shoulder surgery.
      Pain causes a few problems; discomfortable patients, negative outcomes and longer
      rehabilitation. Postoperative effective pain treatment provides early mobilization and
      shorter hospital stay, thus complications due to hospitalization such as infection and
      thromboembolism may be reduced. Various techniques may be used for postoperative pain
      treatment. Opioids are one of the most preferred drugs among the analgesic agents. Parenteral
      opioids are generally performed for patients after surgery. However opioids have undesirable
      adverse events such as nausea, vomiting, itching, sedation and respiratory depression
      (opioid-related adverse events).

      Various methods may be performed to reduce the use of systemic opioids and for effective pain
      treatment following arthroscopic shoulder surgery. Ultrasound (US)-guided brachial plexus
      blocks such as interscalen and supraclavicular block are commonly used. Interscalen brachial
      plexus block (ISCB) is one of the most preferred techniques among these.

      US-guided interfascial plane blocks have been used increasily due to the advantages of
      ultrasound in anesthesia practice. The US-guided erector spina plane block (ESPB) is a novel
      interfacial plan block defined by Forero et al. at 2016. The ESPB contains a local anesthetic
      injection into the deep fascia of erector spinae. This area is away from the pleural and
      neurological structures and thus minimizes the risk of complications due to injury.
      Visualization of sonoanatomy with US is easy, and the spread of local anesthesic agents can
      be easily seen under the erector spinae muscle. Thus, analgesia occurs in several dermatomes
      with cephalad-caudad way. Cadaveric studies have shown that the injection spreads to the
      ventral and dorsal roots of the spinal nerves. ESPB provides thoracic analgesia at T5 level,
      abdominal analgesia at T7-9 level, and lumbar analgesia at T10-12, L3 levels. To the best of
      our knowledge, there have been a few case reports about the efficacy of ESPB for acute and
      chronic shoulder pain. There are no randomized clinical studies, yet.

      The aim of this study is to compare the efficacy of the US-guided ESPB and ISCB for
      postoperative analgesia management after arthroscopic shoulder surgery. The primary aim is to
      compare perioperative and postoperative opioid consumption and the secondary aim is to
      evaluate postoperative pain scores (VAS), adverse effects related with opioids (allergic
      reaction, nausea, vomiting).
    

Intervention name(s): Erector spinae plane block (Group E); Interscalen brachial plexus block (Group I)
Intervention type(s): Other; Other
Intervention description(s): Patients will be administered A 400 mg dose of ibuprofen every 8 hours in the postoperative period. A patient controlled device prepared with 10 mcg/ ml fentanyl will be attached to all patients with a protocol included 10 mcg bolus without infusion dose, 10 min lockout time and 4 hour limit.
Postoperative pain assessment will be performed using the VAS score (0 = no pain, 10 = the most severe pain felt). The VAS scores at rest and during cough will be recorded at postoperative 1, 2, 4, 8, 16, 24 and 48 hours. If the VAS score will be ≥ 4, 0.5 mg/ kg meperidine IV will be administered. Sedation level will be assessed with a 4-point sedation scale (0 = awake, eyes open, 1 = sleepy but responding to verbal stimulus, 2 = sleepy and hard to evoke, 3 = sleepy, not aroused by shaking). The first time of the use of rescue analgesic, intraoperative and postoperative opioid consumption, side effects such as nausea, vomiting, itching and block related complications will be recorded.; Patients will be administered A 400 mg dose of ibuprofen every 8 hours in the postoperative period. A patient controlled device prepared with 10 mcg/ ml fentanyl will be attached to all patients with a protocol included 10 mcg bolus without infusion dose, 10 min lockout time and 4 hour limit.
Postoperative pain assessment will be performed using the VAS score (0 = no pain, 10 = the most severe pain felt). The VAS scores at rest and during cough will be recorded at postoperative 1, 2, 4, 8, 16, 24 and 48 hours. If the VAS score will be ≥ 4, 0.5 mg/ kg meperidine IV will be administered. Sedation level will be assessed with a 4-point sedation scale (0 = awake, eyes open, 1 = sleepy but responding to verbal stimulus, 2 = sleepy and hard to evoke, 3 = sleepy, not aroused by shaking). The first time of the use of rescue analgesic, intraoperative and postoperative opioid consumption, side effects such as nausea, vomiting, itching and block related complications will be recorded.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: There are two models for this study. The first group is erector spinae plane block group. The second one is interscalen brachial plexus block.
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Shoulder surgery; Postoperative pain management; Erector spina plane block